Chronic Subdural HematomaERP-cSDHNCT07421453
Implementation of an Enhanced Recovery Pathway for Burr-hole Drainage in Patients With a Chronic Subdural Hematoma
An observational study of Chronic Subdural Hematoma and Chronic Subdural Hematomas, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
A chronic subdural hematoma (cSDH) is a type of intracranial hematoma that primarily affects older adults. The rising incidence of this condition, coupled with the high healthcare burden of this disease, calls for an update of the medical care program. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Subdural Hematoma, Chronic Subdural Hematomas
- How many people
- 150 participants
- Where
- 1 siteBelgium
- Study dates
- 23 Dec 2024to 31 Jul 2028
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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
Study population: All patients of 18 years or older with a chronic subdural hematoma for which burr-hole drainage is scheduled.
Who may be able to join
- Age 18 years or older
- Existence of a chronic subdural hematoma requiring burr-hole drainage
- Written informed consent to participate in the study must be obtained from the subject. If the subject is not capable of self-consent, all efforts will be made to locate a legally acceptable representative to act on behalf of the subject. When the patient is considered capable to consent but physically unable to sign an informed consent form and a representative is not available an impartial witness can attend the informed consent process.
Who cannot join
- Existence of an important underlying cerebral lesion (e.g. a vascular lesion, tumor)
- History of treatment (surgical or by middle meningeal artery embolization) of a same sided cSDH
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
University Hospitals Leuven
Leuven, 3000
Siebe Orolé, Medical degree, +32 16 34 42 90, neurochirurgie@uzleuven.be
About this study
Official title: Enhanced Recovery Pathway for Chronic Subdural Hematoma
A chronic subdural hematoma (cSDH) is a type of intracranial hematoma that primarily affects older adults. The rising incidence of this condition, coupled with the high healthcare burden of this disease, calls for an update of the medical care program. We introduced an enhanced recovery protocol (ERP) at our center for patients undergoing surgical treatment (by means of burr-hole drainage) for a cSDH. Our ERP includes guidelines for treatment decisions (surgery or middle meningeal artery embolization), modifications in surgical techniques, and standardized postoperative management strategies. This study prospectively analyses the safety and efficacy of this enhanced recovery protocol for patients undergoing burr hole drainage of a chronic subdural hematoma. Safety and efficacy outcomes will be compared with outcomes of a historical patient cohort. Safety of the protocol will be measured in terms of recurrence rate (6-month follow-up, primary outcome), complication incidence, and 30-day mortality. Efficacy of the enhanced recovery protocol will be represented by the length-of-stay.
- Keywords
- Chronic subdural hematoma, Burr-hole drainage, Enhanced recovery protocol
- Medical subject headings
- Hematoma, Subdural, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ERP-cohort | Cohort of patients treated after ERP-implementation, prospective data collection | |
| Pre-ERP-cohort | Patients treated before ERP-implementation, retrospective identified |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate
Recurrence is defined as persistent deficits, clinical deterioration or radiographic hematoma enlargement requiring ipsilateral re-intervention (surgical or by means of middle meningeal artery embolization), assessed until 6 months after index surgery.
Measured: 6 months after surgery
Secondary outcomes (5)
Length-of-stay
Measured: Up to 6 months after surgery
Complication incidence
Complications will be classified as medical complications (any nonsurgical complication occurring during the hospital stay after the surgery) and surgical complications. Medical complications are considered minor if complete recovery is to be expected (eg, electrolyte disturbances or urinary tract infection) and major in case of potential serious consequences and partial or no recovery (eg, stroke, severe pneumonia, or pulmonary embolism). Surgical complications are defined as every complication directly related to the surgery. Epileptic seizures in the postoperative period will be considered separately.
Measured: 30 days after surgery
Mortality
30-day mortality
Measured: 30 days after surgery
5-level EQ-5D (EQ-5D-5L)
The EQ-5D-5L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).
The descriptive systems score ranges from 5 to 25, with a higher score meaning worse health. De EQ VAS is scored from 0 to 100, with a higher score meaning better self-rated health.
Measured: 6 months after surgery
modified Rankin Scale (mRS)
Scale measuring degree of disability or dependence in daily activities, with scores ranging from 0 (no symptoms at all) to 5 (dead).
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start23 Dec 2024
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Subdural HematomaStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Siebe Orolé, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Thomas Decramer, MD, PhD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07421453
- Sponsor's protocol ID
- S68819
- Acronym
- ERP-cSDH
- Status last verified
- Feb 2026
- First submitted
- 1 Sep 2025
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Link TW, Rapoport BI, Paine SM, Kamel H, Knopman J. Middle meningeal artery embolization for chronic subdural hematoma: Endovascular technique and radiographic findings. Interv Neuroradiol. 2018 Aug;24(4):455-462. doi: 10.1177/1591019918769336. Epub 2018 May 2.
PubMed 29720020Feghali J, Yang W, Huang J. Updates in Chronic Subdural Hematoma: Epidemiology, Etiology, Pathogenesis, Treatment, and Outcome. World Neurosurg. 2020 Sep;141:339-345. doi: 10.1016/j.wneu.2020.06.140. Epub 2020 Jun 25.
PubMed 32593768
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Recovery Pathway for Chronic Subdural Hematoma
- ClinicalTrials.gov ID
- NCT07421453
- Acronym / sponsor ID
- ERP-cSDH / S68819
- Keywords
- Chronic subdural hematoma, Burr-hole drainage, Enhanced recovery protocol
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 23 Dec 2024 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 19 Feb 2026 (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.
A chronic subdural hematoma (cSDH) is a type of intracranial hematoma that primarily affects older adults. The rising incidence of this condition, coupled with the high healthcare burden of this disease, calls for an update of the medical care program. We introduced an enhanced recovery protocol (ERP) at our center for patients undergoing surgical treatment (by means of burr-hole drainage) for a cSDH. Our ERP includes guidelines for treatment decisions (surgery or middle meningeal artery embolization), modifications in surgical techniques, and standardized postoperative management strategies. This study prospectively analyses the safety and efficacy of this enhanced recovery protocol for patients undergoing burr hole drainage of a chronic subdural hematoma. Safety and efficacy outcomes will be compared with outcomes of a historical patient cohort. Safety of the protocol will be measured in terms of recurrence rate (6-month follow-up, primary outcome), complication incidence, and 30-day mortality. Efficacy of the enhanced recovery protocol will be represented by the length-of-stay.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERP-cohort | – | –Cohort of patients treated after ERP-implementation, prospective data collection |
| Pre-ERP-cohort | – | –Patients treated before ERP-implementation, retrospective identified |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients of 18 years or older with a chronic subdural hematoma for which burr-hole drainage is scheduled.
Key inclusion criteria (3 listed)
- Age 18 years or older
- Existence of a chronic subdural hematoma requiring burr-hole drainage
- Written informed consent to participate in the study must be obtained from the subject. If the subject is not capable of self-consent, all efforts will be made to locate a legally acceptable representative to act on behalf of the subject. When the patient is considered capable to consent but physically unable to sign an informed consent form and a representative is not available an impartial witness can attend the informed consent process.
Key exclusion criteria (2 listed)
- Existence of an important underlying cerebral lesion (e.g. a vascular lesion, tumor)
- History of treatment (surgical or by middle meningeal artery embolization) of a same sided cSDH
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Recurrence rate
Time frame: 6 months after surgery
Recurrence is defined as persistent deficits, clinical deterioration or radiographic hematoma enlargement requiring ipsilateral re-intervention (surgical or by means of middle meningeal artery embolization), assessed until 6 months after index surgery.
5 secondary outcomes
Length-of-stay
Time frame: Up to 6 months after surgery
Complication incidence
Time frame: 30 days after surgery
Mortality
Time frame: 30 days after surgery
5-level EQ-5D (EQ-5D-5L)
Time frame: 6 months after surgery
modified Rankin Scale (mRS)
Time frame: 6 months after surgery
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 19 Feb 2026.
- Background: PubMed 29720020Link TW, Rapoport BI, Paine SM, Kamel H, Knopman J. Middle meningeal artery embolization for chronic subdural hematoma: Endovascular technique and radiographic findings. Interv Neuroradiol. 2018 Aug;24(4):455-462. doi: 10.1177/1591019918769336. Epub 2018 May 2.
- Background: PubMed 32593768Feghali J, Yang W, Huang J. Updates in Chronic Subdural Hematoma: Epidemiology, Etiology, Pathogenesis, Treatment, and Outcome. World Neurosurg. 2020 Sep;141:339-345. doi: 10.1016/j.wneu.2020.06.140. Epub 2020 Jun 25.
- Individual participant dataSharing planned: Undecided
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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.
Thomas Decramer, MD, PhD principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Subdural Hematoma and Chronic Subdural Hematomas, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 3 inclusion and 2 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 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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 Siebe Orolé, Medical degree (+32 16 34 42 90, neurochirurgie@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate (time frame: 6 months after surgery). 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 NCT07421453, which also lists 2 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 19 Feb 2026.