Chronic Subdural HematomaSUPERDURANCT06621407
A National Study Examining the Most Effective Drainage Method After Burr Hole Evacuation of Chronic Subdural Hematoma
A study testing 24 hours active subperiostal drainage and 24 hours passive subdural drainage in people with Chronic Subdural Hematoma and Surgical Procedures, Operative, run by Aalborg University Hospital at 4 sites in Denmark.
Trial summary
Chronic subdural hematoma (CSDH) is a common disease. The main treatment is neurosurgical evacuation and subsequent hematoma drainage. However, consensus on the optimal drain placement site, and whether the drainage should be active or passive, is lacking. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Subdural Hematoma, Surgical Procedures, Operative, Recurrence
- What is being tested?
- 24 hours active subperiostal drainage and 24 hours passive subdural drainage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 354 participants
- Where
- 4 sitesDenmark
- Study dates
- 1 Sep 2025to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (≥ 18 years).
- Patients with symptomatic CSDH confirmed on brain CT- or magnetic resonance imaging (MRI), admitted to a Danish neurosurgical department for surgical treatment.
- Patients undergoing a single burr-hole evacuation.
- Informed written and oral consent is taken prior to surgery.
Who cannot join
- Patients who are mentally incapacitated
- Patients with known abnormalities in their cerebrospinal fluid (protein and glucose levels, cell count, and type)
- Patients with changes or abnormalities in their normal cerebrospinal fluid dynamics, e.g., obstructive hydrocephalus, normal pressure hydrocephalus, intracranial hypotension, and ventricular peritoneal shunt.
- Patients with additional/previously intracranial pathology that requires/has required neurosurgical treatment (e.g., brain tumor, vascular malformation, abscess).
- Patients with recurrent CSDH or with previous craniotomy or other transcranial surgery (for any reason)
- Patients unable to give consent prior to surgery
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark4 sites, 4 recruiting
- Recruiting
Department of Neurosurgery, Aalborg University Hospital
Aalborg, 9000
Carsten R Bjarkam, MD, PhD, DMSc, 45 + 21167118, c.bjarkam@rn.dk
Rares Miscov, MD, 45 + 27831360, ram@rn.dk
- Recruiting
Department of Neurosurgery, Aarhus University Hospital
Aarhus, 8000
Anders R Korshøj, MD, PhD, 45 + 23882226, andekors@rm.dk
- Recruiting
Department of Neurosurgery, Copenhagen University Hospital Rigshospitalet
Copenhagen, 2100
Thorbjørn R Jensen, MD, PhD, 45 + 35456031, thorbjoern.soeren.roenn.jensen.01@regionh.dk
- Recruiting
Department of Neurosurgery, Odense University Hospital
Odense, 5100
Frantz R Poulsen, MD, PhD,, 45 + 65413600, frantz.r.poulsen@rsyd.dk
About this study
Official title: Active 24 Hours Subperiostal vs. 24 Hours Passive Subdural Drainage Following Burr Hole Evacuation of Chronic Subdural Hematoma (the SUPERDURA Trial) - Protocol for a Nationwide Randomized Clinical Non-inferiority Trial
Chronic subdural hematoma (CSDH) is a common disease. The main treatment is neurosurgical evacuation and subsequent hematoma drainage. However, consensus on the optimal drain placement site, and whether the drainage should be active or passive, is lacking.
The aim of the current study is to test the hypothesis that 24 hours active subperiosteal drainage is non-inferior to 24 hours passive subdural drainage after single burr hole evacuation of a unilateral CSDH.
Read more
The study is a multicenter randomized non-inferiority trial encompassing all neurosurgical units in Denmark.
Adult patients with symptomatic CSDH admitted to a Danish neurosurgical unit for single burr hole evacuation will be screened for inclusion. Patients who are not able to give informed consent, and patients with recurrent CSDH, known cerebrospinal fluid abnormalities, and other known brain pathologies will be excluded. Patients with bilateral CSDH will be registered as one case and treated similarly on both sides.
Before surgical hematoma evacuation patients will be randomized to 24-hour passive subdural drainage or 24-hour active subperiosteal drainage.
The patients included and the two study statisticians will be blinded. The primary outcome is a composite outcome of 90-day mortality and symptomatic CSDH recurrence.
Secondary outcomes are 90-day simplified modified Rankin score (smRSq), and complications related to surgery or occurring during admission, including intracerebral hemorrhage due to misplaced drains, acute subdural hematoma, tension pneumocephalus, wound infection, drain seepage, subperiosteal hematoma, thromboembolic events, infections and seizures.
Sample size simulations of non-inferiority with a threshold of 7% increased relative risk show that a total of 354 participants will be required to demonstrate a relative risk reduction of recurrent CSDH and mortality of 30% for the cohort receiving active subperiosteal drainage given a stable power above 80% with an alpha of 5%. The study inclusion period is estimated to last 2 years.
Ethics approval for inclusion of competent patients has been obtained (N-20240009).
Read the detailed description
The incidence of symptomatic chronic subdural hematoma (CSDH) is sharply on the rise due to an ageing population, and population risk factors such as alcohol misuse, falls, and use of anticoagulants and -platelets. The treatment of symptomatic CSDH is neurosurgical hematoma evacuation followed by drain placement to facilitate subsequent postoperative drainage. Accordingly, in many general neurosurgical departments this is the most common cranial procedure performed on a daily basis. However, no consensus exists on the actual surgical technique (hematoma evacuation by one burr hole, more burr holes or a larger cranial opening (craniotomy), hematoma irrigation method, drain placement site (subdural or subperiostal), and drainage method (time, active versus passive). This was also the case in Denmark where the actual CDSH evacuation technique differed vastly between departments and between neurosurgeons at the same department, although there only were four neurosurgical units in Denmark treating patients with symptomatic CSDH. Accordingly, in 2012 on the initiative of the four Danish neurosurgical departments the Danish Chronic Subdural Hematoma group (DACSUHS) was established in order to generate evidence based guidelines for the treatment of CSDH, standardize the treatment, and conduct national multicenter CSDH research. The first national CSDH treatment guideline was based on data collected retrospectively from 2010 to 2012, rigorous literature search, and a concluding Delphi process in the DACSUHS consortium, before it was finally published in 2018. It reflects the best available evidence regarding 10 aspects of CSDH management, including preoperative evaluation, surgical approach, postoperative mobilization, and use of postoperative head CT. Furthermore, it enabled the standardization of the CSDH treatment in all Danish departments by requiring the use of the same operative technique, drains, fixation technique for drains, and written patient information. The standardized CSDH approach enabled also the initiation of two larger prospective national multicenter trials evaluating the optimal postoperative drainage time in relation to CSDH recurrence rate and patient mortality. These above-mentioned process steps haves resulted in the current Danish CSDH treatment algorithm recommending evacuation of symptomatic CSDH by a single perforator made 13-mm burr hole above the maximum width of the hematoma followed by subdural temperate isotonic saline irrigation and subsequent placement of a subdural drain for 24 hours.
The subdural drain placement has, however, been much debated as drain placement through the skull burr hole in the subdural space in direct proximity to the brain may result in brain lesions, bleeding, seizures, and intracranial infections.
Therefore, burr hole craniostomy with subperiosteal drainage (also known as subgaleal drainage) has been suggested as an equally safe and effective treatment of CSDH due to less invasiveness and lower risk of drain inflicted brain parenchyma injury.
Neurosurgeons have generally been reluctant to use active (vacuum) drainage on subdural drains due to their proximity to the brain, whereas active drainage is more common active with subperiostal drainage has been more common. Although a direct comparison is lacking, it has been shown in a paper comparing three different Scandinavian centers using active subperiostal drainage, passive subdural drainage, and subdural drainage with continuously irrigation, that patients receiving passive drainage had the highest recurrence rate (20% vs. 11%) and on average a slightly higher complication rate (8.1% vs. 7.3%) and mortality rate (7.3% vs. 5.8%) compared to active subperiostal drainage which had a recurrence rate of 11.1% and a complication and mortality rate of 7.3% and 5.8%, respectively. Similarly, Post-hoc analysis of the cSDH-Drain and the TOSCAN studies have likewise revealed a higher recurrence rate (23.1% vs 14.1%) in patients receiving passive compared to active drainage.
Accordingly, as active subperiostal drainage might seem to be more safe and more efficient, the investigators find it justified to examine if 24 hours active subperiostal drainage is non-inferior to our current gold standard of 24 hours passive subdural drainage in a randomized clinical trial (the SuperDura trial).
The obtained results from the SuperDura trial will not only have major relevance for neurosurgical praxis as the investigators perform the first direct comparison between two commonly used drainage methods on a national level.
- Conditions
- Chronic Subdural Hematoma, Surgical Procedures, Operative, Recurrence, Mortality, Drainage, Drainage/Methods
- Being tested
- 24 hours active subperiostal drainage, 24 hours passive subdural drainage
- Medical subject headings
- Hematoma, Subdural, Chronic, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
24 hours active subperiostal drainageProcedure or surgery
24 hours active subperiostal drainage after single burr hole evacuation of a chronic subdural hematoma
24 hours passive subdural drainageProcedure or surgery
24 hours passive subdural drainage after single burr hole evacuation of a chronic subdural hematoma
| Study group | Role | What they receive |
|---|---|---|
| 24 hours active subperiostal drainage | Experimental | 24 hours active subperiostal drainage after single burr hole evacuation of a chronic subdural hematoma Receives: Procedure: 24 hours active subperiostal drainage |
| 24 hours passive subdural drainage | Experimental | 24 hours passive subdural drainage after single burr hole evacuation of a chronic subdural hematoma Receives: Procedure: 24 hours passive subdural drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite outcome of 90-day mortality and recurrent CSDH on the same side as the primary operation requiring reoperation within the 90-day observation period
The primary outcome measure is a composite outcome of 90-day mortality and recurrent CSDH on the same side as the primary operation requiring reoperation within the 90-day observation period. Recurrent CSDH is defined as a re-accumulation of the previously treated CSDH requiring ipsilateral or bilateral reoperation following symptom improvement after the first operation. For both unilateral and bilateral hematomas, recurrence will be considered as one reoperation.
Measured: From enrollment to 90-days postsurgery
Secondary outcomes (9)
90-day simplified modified Rankin scale
The scores on the simplified modified Rankin scale will be assessed with the use of the simplified mRS validated questionnaire, which will be completed over the telephone by the patients or next of kin at 90 (80-100) days after surgery. The results will be dichotomized and analyzed with 0-2 as favourable clinical outcome and 3-6 as unfavourable outcome.
Measured: 90 days after enrollment
90-day serious adverse events (SAE)
Serious adverse events (SAE) necessitating new hospitalization in the 90 days postoperative period
Measured: From time of surgery to 90-days postoperative
Complications related to surgery
Complications related to surgery encompasing intracerebral hemorrhage due to misplaced drains, acute subdural hematoma, tension pneumocephalus, wound infection, drain seepage, subperiostal hematoma, and seizures.
Measured: From enrollment to 90-days postsurgery
Postoperative adverse events during the admission
Postoperative adverse events during the admission emcompassing thromboembolic events and/or infections.
Measured: From enrollment to admission from hospital assessed up to 90-days postsurgery
Length of hospitalization
Length (days) of admission to neurosurgical department. Length (days) of hospitalization in total after surgical CSDH evacuation
Measured: From enrollment to admission from neurosurgical department, and from surgical CSDH evacuation to discarge to home or nursing facility, assessed up to 90-days postsurgery
Simplified mRSq as an ordinal outcome
Ordinal predentation of the 90-day simplified mRSq.
Measured: 90-days postoperative
90-day mortality and registered cause of death.
Mortality within 90 days of the performed surgery
Registred cause of death
Measured: From enrollment to 90-days postsurgery
90-day recurrent symptomatic CSDH requiring ipsilateral or bilateral reoperation within 90 days.
Recurrent symptomatic CSDH requiring ipsilateral or bilateral reoperation within 90 days. For both unilateral and bilateral hematomas, recurrence will be considered as one reoperation.
Measured: From surgery to 90-day postsurgery
Discharge destination
Discharge destination after completed neurosurgical CSDH evacuation encompassing home, nursing home, other hospital department
Measured: From enrollment to 90-days postsurgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start1 Sep 2025
- Primary completionAug 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Subdural HematomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized multicenter clinical non-inferiority trial encompassing all neurosurgical units in Denmark. All adult patients with symptomatic unilateral CSDH admitted to a Danish neurosurgical unit for single burr hole evacuation will be considered for inclusion. Before surgical hematoma evacuation patients will be randomized to 24 hours passive subdural drainage or 24 hours active subperiostal drainage, and the drain placed accordingly at the end of the hematoma evacuation procedure. The primary end point is a composite outcome of 90-day mortality, and recurrent CSDH on the same side as the primary operation requiring reoperation within the 90-day follow-up period.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 354 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital, Copenhagen University Hospital, Rigshospitalet, Aarhus University Hospital
- Responsible party
- Principal investigator, Carsten Reidies Bjarkam, Aalborg University Hospital
- Investigators
- Carsten R Bjarkam, MD, PhD, DMSc, Study director, Department of Neurosurgery, Aalborg University Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06621407
- Sponsor's protocol ID
- N-20240009
- Acronym
- SUPERDURA
- Status last verified
- Nov 2025
- First submitted
- 19 Sep 2024
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data will be shared in annonymized form.
Publications
Hjortdal Gronhoj M, Jensen TSR, Miscov R, Sindby AK, Debrabant B, Hundsholt T, Bjarkam CR, Bergholt B, Fugleholm K, Poulsen FR; DACSUHS group. Optimal drainage time after evacuation of chronic subdural haematoma (DRAIN TIME 2): a multicentre, randomised, multiarm and multistage non-inferiority trial in Denmark. Lancet Neurol. 2024 Aug;23(8):787-796. doi: 10.1016/S1474-4422(24)00175-3. Epub 2024 Jun 12.
PubMed 38878790Miscov R, Gronhoj M, Ronn Jensen TS, Schack AE, Korshoej AR, Haldrup M, Olsen MH, Holmen Terkelsen J, Poulsen FR, Fugleholm K, Bjarkam C. Active subperiosteal versus passive subdural 24-hour drainage following single burr hole evacuation of chronic subdural haematoma (the SUPERDURA trial): protocol for a multicentre, randomised non-inferiority trial. BMJ Open. 2026 Apr 15;16(4):e102410. doi: 10.1136/bmjopen-2025-102410.
PubMed 41985955Holmen Terkelsen J, Miscov R, Gronhoj MH, Soren Ronn Jensen T, Schack A, Haldrup M, Harboe Olsen M, Rosendal Korshoj A, Rom Poulsen F, Fugleholm K, Reidies Bjarkam C. Subperiosteal Drain Insertion and Anchorage after Single Burr Hole Evacuation of Chronic Subdural Hematoma. J Vis Exp. 2026 Jan 16;(227). doi: 10.3791/69808.
PubMed 41628070Terkelsen JH, Miscov R, Jensen TSR, Schack A, Gronhoj MH, Korshoj AR, Haldrup M, Poulsen FR, Fugleholm K, Bjarkam CR, Olsen MH. Active subperiosteal vs. passive subdural 24-h drainage following single burr hole evacuation of chronic subdural hematoma: statistical analysis plan for the multicenter, randomized, non-inferiority clinical trial SUPERDURA. Trials. 2026 Jan 17;27(1):129. doi: 10.1186/s13063-026-09434-8.
PubMed 41546119
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active 24 Hours Subperiostal vs. 24 Hours Passive Subdural Drainage Following Burr Hole Evacuation of Chronic Subdural Hematoma (the SUPERDURA Trial) - Protocol for a Nationwide Randomized Clinical Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT06621407
- Acronym / sponsor ID
- SUPERDURA / N-20240009
- Conditions
- Chronic Subdural Hematoma, Surgical Procedures, Operative, Recurrence, Mortality, Drainage, Drainage/Methods
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 354 participants (estimated)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Collaborators
- Odense University Hospital, Copenhagen University Hospital, Rigshospitalet, Aarhus University Hospital
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic subdural hematoma (CSDH) is a common disease. The main treatment is neurosurgical evacuation and subsequent hematoma drainage. However, consensus on the optimal drain placement site, and whether the drainage should be active or passive, is lacking.
The aim of the current study is to test the hypothesis that 24 hours active subperiosteal drainage is non-inferior to 24 hours passive subdural drainage after single burr hole evacuation of a unilateral CSDH.
The study is a multicenter randomized non-inferiority trial encompassing all neurosurgical units in Denmark.
Adult patients with symptomatic CSDH admitted to a Danish neurosurgical unit for single burr hole evacuation will be screened for inclusion. Patients who are not able to give informed consent, and patients with recurrent CSDH, known cerebrospinal fluid abnormalities, and other known brain pathologies will be excluded. Patients with bilateral CSDH will be registered as one case and treated similarly on both sides.
Before surgical hematoma evacuation patients will be randomized to 24-hour passive subdural drainage or 24-hour active subperiosteal drainage.
The patients included and the two study statisticians will be blinded. The primary outcome is a composite outcome of 90-day mortality and symptomatic CSDH recurrence.
Secondary outcomes are 90-day simplified modified Rankin score (smRSq), and complications related to surgery or occurring during admission, including intracerebral hemorrhage due to misplaced drains, acute subdural hematoma, tension pneumocephalus, wound infection, drain seepage, subperiosteal hematoma, thromboembolic events, infections and seizures.
Sample size simulations of non-inferiority with a threshold of 7% increased relative risk show that a total of 354 participants will be required to demonstrate a relative risk reduction of recurrent CSDH and mortality of 30% for the cohort receiving active subperiosteal drainage given a stable power above 80% with an alpha of 5%. The study inclusion period is estimated to last 2 years.
Ethics approval for inclusion of competent patients has been obtained (N-20240009).
Detailed description
The incidence of symptomatic chronic subdural hematoma (CSDH) is sharply on the rise due to an ageing population, and population risk factors such as alcohol misuse, falls, and use of anticoagulants and -platelets. The treatment of symptomatic CSDH is neurosurgical hematoma evacuation followed by drain placement to facilitate subsequent postoperative drainage. Accordingly, in many general neurosurgical departments this is the most common cranial procedure performed on a daily basis. However, no consensus exists on the actual surgical technique (hematoma evacuation by one burr hole, more burr holes or a larger cranial opening (craniotomy), hematoma irrigation method, drain placement site (subdural or subperiostal), and drainage method (time, active versus passive). This was also the case in Denmark where the actual CDSH evacuation technique differed vastly between departments and between neurosurgeons at the same department, although there only were four neurosurgical units in Denmark treating patients with symptomatic CSDH. Accordingly, in 2012 on the initiative of the four Danish neurosurgical departments the Danish Chronic Subdural Hematoma group (DACSUHS) was established in order to generate evidence based guidelines for the treatment of CSDH, standardize the treatment, and conduct national multicenter CSDH research. The first national CSDH treatment guideline was based on data collected retrospectively from 2010 to 2012, rigorous literature search, and a concluding Delphi process in the DACSUHS consortium, before it was finally published in 2018. It reflects the best available evidence regarding 10 aspects of CSDH management, including preoperative evaluation, surgical approach, postoperative mobilization, and use of postoperative head CT. Furthermore, it enabled the standardization of the CSDH treatment in all Danish departments by requiring the use of the same operative technique, drains, fixation technique for drains, and written patient information. The standardized CSDH approach enabled also the initiation of two larger prospective national multicenter trials evaluating the optimal postoperative drainage time in relation to CSDH recurrence rate and patient mortality. These above-mentioned process steps haves resulted in the current Danish CSDH treatment algorithm recommending evacuation of symptomatic CSDH by a single perforator made 13-mm burr hole above the maximum width of the hematoma followed by subdural temperate isotonic saline irrigation and subsequent placement of a subdural drain for 24 hours.
The subdural drain placement has, however, been much debated as drain placement through the skull burr hole in the subdural space in direct proximity to the brain may result in brain lesions, bleeding, seizures, and intracranial infections.
Therefore, burr hole craniostomy with subperiosteal drainage (also known as subgaleal drainage) has been suggested as an equally safe and effective treatment of CSDH due to less invasiveness and lower risk of drain inflicted brain parenchyma injury.
Neurosurgeons have generally been reluctant to use active (vacuum) drainage on subdural drains due to their proximity to the brain, whereas active drainage is more common active with subperiostal drainage has been more common. Although a direct comparison is lacking, it has been shown in a paper comparing three different Scandinavian centers using active subperiostal drainage, passive subdural drainage, and subdural drainage with continuously irrigation, that patients receiving passive drainage had the highest recurrence rate (20% vs. 11%) and on average a slightly higher complication rate (8.1% vs. 7.3%) and mortality rate (7.3% vs. 5.8%) compared to active subperiostal drainage which had a recurrence rate of 11.1% and a complication and mortality rate of 7.3% and 5.8%, respectively. Similarly, Post-hoc analysis of the cSDH-Drain and the TOSCAN studies have likewise revealed a higher recurrence rate (23.1% vs 14.1%) in patients receiving passive compared to active drainage.
Accordingly, as active subperiostal drainage might seem to be more safe and more efficient, the investigators find it justified to examine if 24 hours active subperiostal drainage is non-inferior to our current gold standard of 24 hours passive subdural drainage in a randomized clinical trial (the SuperDura trial).
The obtained results from the SuperDura trial will not only have major relevance for neurosurgical praxis as the investigators perform the first direct comparison between two commonly used drainage methods on a national level.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized multicenter clinical non-inferiority trial encompassing all neurosurgical units in Denmark. All adult patients with symptomatic unilateral CSDH admitted to a Danish neurosurgical unit for single burr hole evacuation will be considered for inclusion. Before surgical hematoma evacuation patients will be randomized to 24 hours passive subdural drainage or 24 hours active subperiostal drainage, and the drain placed accordingly at the end of the hematoma evacuation procedure. The primary end point is a composite outcome of 90-day mortality, and recurrent CSDH on the same side as the primary operation requiring reoperation within the 90-day follow-up period.
| Arm | Type | Receives |
|---|---|---|
| 24 hours active subperiostal drainage | Experimental | Procedure: 24 hours active subperiostal drainage24 hours active subperiostal drainage after single burr hole evacuation of a chronic subdural hematoma |
| 24 hours passive subdural drainage | Experimental | Procedure: 24 hours passive subdural drainage24 hours passive subdural drainage after single burr hole evacuation of a chronic subdural hematoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients (≥ 18 years).
- Patients with symptomatic CSDH confirmed on brain CT- or magnetic resonance imaging (MRI), admitted to a Danish neurosurgical department for surgical treatment.
- Patients undergoing a single burr-hole evacuation.
- Informed written and oral consent is taken prior to surgery.
Key exclusion criteria (6 listed)
- Patients who are mentally incapacitated
- Patients with known abnormalities in their cerebrospinal fluid (protein and glucose levels, cell count, and type)
- Patients with changes or abnormalities in their normal cerebrospinal fluid dynamics, e.g., obstructive hydrocephalus, normal pressure hydrocephalus, intracranial hypotension, and ventricular peritoneal shunt.
- Patients with additional/previously intracranial pathology that requires/has required neurosurgical treatment (e.g., brain tumor, vascular malformation, abscess).
- Patients with recurrent CSDH or with previous craniotomy or other transcranial surgery (for any reason)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 24 hours active subperiostal drainage24 hours active subperiostal drainage after single burr hole evacuation of a chronic subdural hematoma | Procedure or surgery | 24 hours active subperiostal drainage |
| 24 hours passive subdural drainage24 hours passive subdural drainage after single burr hole evacuation of a chronic subdural hematoma | Procedure or surgery | 24 hours passive subdural drainage |
Primary outcome
Composite outcome of 90-day mortality and recurrent CSDH on the same side as the primary operation requiring reoperation within the 90-day observation period
Time frame: From enrollment to 90-days postsurgery
The primary outcome measure is a composite outcome of 90-day mortality and recurrent CSDH on the same side as the primary operation requiring reoperation within the 90-day observation period. Recurrent CSDH is defined as a re-accumulation of the previously treated CSDH requiring ipsilateral or bilateral reoperation following symptom improvement after the first operation. For both unilateral and bilateral hematomas, recurrence will be considered as one reoperation.
9 secondary outcomes
90-day simplified modified Rankin scale
Time frame: 90 days after enrollment
90-day serious adverse events (SAE)
Time frame: From time of surgery to 90-days postoperative
Complications related to surgery
Time frame: From enrollment to 90-days postsurgery
Postoperative adverse events during the admission
Time frame: From enrollment to admission from hospital assessed up to 90-days postsurgery
Length of hospitalization
Time frame: From enrollment to admission from neurosurgical department, and from surgical CSDH evacuation to discarge to home or nursing facility, assessed up to 90-days postsurgery
Simplified mRSq as an ordinal outcome
Time frame: 90-days postoperative
90-day mortality and registered cause of death.
Time frame: From enrollment to 90-days postsurgery
90-day recurrent symptomatic CSDH requiring ipsilateral or bilateral reoperation within 90 days.
Time frame: From surgery to 90-day postsurgery
Discharge destination
Time frame: From enrollment to 90-days postsurgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Background: PubMed 38878790Hjortdal Gronhoj M, Jensen TSR, Miscov R, Sindby AK, Debrabant B, Hundsholt T, Bjarkam CR, Bergholt B, Fugleholm K, Poulsen FR; DACSUHS group. Optimal drainage time after evacuation of chronic subdural haematoma (DRAIN TIME 2): a multicentre, randomised, multiarm and multistage non-inferiority trial in Denmark. Lancet Neurol. 2024 Aug;23(8):787-796. doi: 10.1016/S1474-4422(24)00175-3. Epub 2024 Jun 12.
- Derived from this study: PubMed 41985955Miscov R, Gronhoj M, Ronn Jensen TS, Schack AE, Korshoej AR, Haldrup M, Olsen MH, Holmen Terkelsen J, Poulsen FR, Fugleholm K, Bjarkam C. Active subperiosteal versus passive subdural 24-hour drainage following single burr hole evacuation of chronic subdural haematoma (the SUPERDURA trial): protocol for a multicentre, randomised non-inferiority trial. BMJ Open. 2026 Apr 15;16(4):e102410. doi: 10.1136/bmjopen-2025-102410.
- Derived from this study: PubMed 41628070Holmen Terkelsen J, Miscov R, Gronhoj MH, Soren Ronn Jensen T, Schack A, Haldrup M, Harboe Olsen M, Rosendal Korshoj A, Rom Poulsen F, Fugleholm K, Reidies Bjarkam C. Subperiosteal Drain Insertion and Anchorage after Single Burr Hole Evacuation of Chronic Subdural Hematoma. J Vis Exp. 2026 Jan 16;(227). doi: 10.3791/69808.
- Derived from this study: PubMed 41546119Terkelsen JH, Miscov R, Jensen TSR, Schack A, Gronhoj MH, Korshoj AR, Haldrup M, Poulsen FR, Fugleholm K, Bjarkam CR, Olsen MH. Active subperiosteal vs. passive subdural 24-h drainage following single burr hole evacuation of chronic subdural hematoma: statistical analysis plan for the multicenter, randomized, non-inferiority clinical trial SUPERDURA. Trials. 2026 Jan 17;27(1):129. doi: 10.1186/s13063-026-09434-8.
- Individual participant dataSharing planned: Yes. All collected data will be shared in annonymized form.
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Middle Meningeal Artery Embolization (MMAE) Outcomes for Chronic Subdural Hematoma (cSDH)
Chronic Subdural Hematoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carsten R Bjarkam, MD, PhD, DMSc study director
Department of Neurosurgery, Aalborg University Hospital, Denmark
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 24 hours active subperiostal drainage and 24 hours passive subdural drainage in people with Chronic Subdural Hematoma and Surgical Procedures, Operative, run by Aalborg University Hospital at 4 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carsten R Bjarkam, Professor, Ph.D., DMSc. (45+ 211671, c.bjarkam@rn.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite outcome of 90-day mortality and recurrent CSDH on the same side as the primary operation requiring reoperation within the 90-day observation period (time frame: From enrollment to 90-days postsurgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06621407, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.