Chronic Subdural HematomaNCT07688473
Surgical Management of Chronic Subdural Hematoma: Clinical Outcomes Following Single VS Double Burr Holes Evacuation
A study testing Chronic Subdural Hematoma Evacuation in people with Chronic Subdural Hematoma, run by Sohag University at 1 site in Egypt.
Trial summary
This study aims to evaluate and compare the clinical and radiological outcomes of patients with chronic subdural hematoma (CSDH) undergoing surgical evacuation using either single or double burr-hole craniostomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Subdural Hematoma
- What is being tested?
- Chronic Subdural Hematoma Evacuation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 31 Dec 2026
- 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
- Patients aged ≥18 years
- Radiologically confirmed chronic subdural hematoma by CT and/or MRI
- Symptomatic patients indicated for surgical evacuation
- Patients treated by burr-hole craniostomy (single or double)
Who cannot join
- Acute or subacute subdural hematomas
- Patients managed by craniotomy flap
- Uncorrected coagulopathy
- Patients on anticoagulant or antiplatelet therapy without proper perioperative management
- Patients with severe comorbid conditions significantly affecting outcomes
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to evaluate and compare the clinical and radiological outcomes of patients with chronic subdural hematoma (CSDH) undergoing surgical evacuation using either single or double burr-hole craniostomy.
The comparison focuses on key outcome measures including recurrence rate, postoperative complications, neurological improvement, length of hospital stay, and overall functional recovery, in order to determine the most effective and safe surgical technique.
- Conditions
- Chronic Subdural Hematoma
- Being tested
- Chronic Subdural Hematoma Evacuation
- 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.
Chronic Subdural Hematoma EvacuationProcedure or surgery
Single burr-hole technique: A single burr hole was made over the maximum thickness of the hematoma followed by dural opening, irrigation with warm saline, and placement of a drain.
Double burr-hole technique: Two burr holes were created (frontal and parietal), allowing more extensive irrigation and evacuation of the hematoma, followed by drain placement.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Patients who underwent single burr-hole craniostomy Receives: Procedure: Chronic Subdural Hematoma Evacuation |
| Group B | Active comparator | Patients who underwent double burr-hole craniostomy Receives: Procedure: Chronic Subdural Hematoma Evacuation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence
re-accumulation requiring re-operation
Measured: 6 months
Secondary outcomes (5)
Infection
invasion and multiplication of pathogenic microorganisms in a host, causing a local or systemic immune response, which may or may not result in clinical disease.
Measured: 6 months
Seizures
sudden, uncontrolled electrical disturbance in the brain that can cause changes in behavior, movement, sensation, consciousness, or autonomic function
Measured: 6 months
Pneumocephalus
presence of air within the intracranial cavity
Measured: 6 months
Glasgow Coma Scale
evaluate the level of consciousness in patients with acute brain injury by assessing three components: eye opening, verbal response, and motor response.score ranges from 3 to 15, with lower scores indicating more severe impairment of consciousness.
Measured: 6 months
Motor Power
strength generated by voluntary contraction of a muscle or muscle group and is assessed during neurological examination to evaluate the integrity of the motor system. It is commonly graded using the Medical Research Council (MRC) Muscle Strength Scale.ranging from 0 (no contraction) to 5 (normal strength), with higher vlaues indicating better outcomes.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start1 Jan 2022
- Primary completion31 Dec 2025
- Study completion31 Dec 2026 (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 Sohag UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatem Yousry, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07688473
- Sponsor's protocol ID
- Soh-Med-26-6-14MS
- Status last verified
- Jun 2026
- First submitted
- 23 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kumar D, Kumar A, Anwer M, Khan AV, Kumar H, Sridhar R, Hakeem A, Kumar A, Kumar A. Effectiveness of Single Versus Double Burr Hole for Chronic Subdural Hematoma: A Randomized Controlled Trial. Korean J Neurotrauma. 2026 Mar 6;22(2):149-158. doi: 10.13004/kjnt.2026.22.e11. eCollection 2026 Apr.
PubMed 42111450Sale D. Single versus Double Burr Hole for Drainage of Chronic Subdural Hematoma: Randomized Controlled Study. World Neurosurg. 2021 Feb;146:e565-e567. doi: 10.1016/j.wneu.2020.10.140. Epub 2020 Oct 28.
PubMed 33130139
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Management of Chronic Subdural Hematoma: Clinical Outcomes Following Single VS Double Burr Holes Evacuation
- ClinicalTrials.gov ID
- NCT07688473
- Acronym / sponsor ID
- Soh-Med-26-6-14MS
- Conditions
- Chronic Subdural Hematoma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 7 Jul 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.
This study aims to evaluate and compare the clinical and radiological outcomes of patients with chronic subdural hematoma (CSDH) undergoing surgical evacuation using either single or double burr-hole craniostomy.
The comparison focuses on key outcome measures including recurrence rate, postoperative complications, neurological improvement, length of hospital stay, and overall functional recovery, in order to determine the most effective and safe surgical technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Procedure: Chronic Subdural Hematoma EvacuationPatients who underwent single burr-hole craniostomy |
| Group B | Active comparator | Procedure: Chronic Subdural Hematoma EvacuationPatients who underwent double burr-hole craniostomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged ≥18 years
- Radiologically confirmed chronic subdural hematoma by CT and/or MRI
- Symptomatic patients indicated for surgical evacuation
- Patients treated by burr-hole craniostomy (single or double)
Key exclusion criteria (5 listed)
- Acute or subacute subdural hematomas
- Patients managed by craniotomy flap
- Uncorrected coagulopathy
- Patients on anticoagulant or antiplatelet therapy without proper perioperative management
- Patients with severe comorbid conditions significantly affecting outcomes
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 |
|---|---|---|
| Chronic Subdural Hematoma EvacuationSingle burr-hole technique: A single burr hole was made over the maximum thickness of the hematoma followed by dural opening, irrigation with warm saline, and placement of a drain. Double burr-hole technique: Two burr holes were created (frontal and parietal), allowing more extensive irrigation and evacuation of the hematoma, followed by drain placement. | Procedure or surgery | Group A, Group B |
Primary outcome
Recurrence
Time frame: 6 months
re-accumulation requiring re-operation
5 secondary outcomes
Infection
Time frame: 6 months
Seizures
Time frame: 6 months
Pneumocephalus
Time frame: 6 months
Glasgow Coma Scale
Time frame: 6 months
Motor Power
Time frame: 6 months
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 7 Jul 2026.
- Background: PubMed 42111450Kumar D, Kumar A, Anwer M, Khan AV, Kumar H, Sridhar R, Hakeem A, Kumar A, Kumar A. Effectiveness of Single Versus Double Burr Hole for Chronic Subdural Hematoma: A Randomized Controlled Trial. Korean J Neurotrauma. 2026 Mar 6;22(2):149-158. doi: 10.13004/kjnt.2026.22.e11. eCollection 2026 Apr.
- Background: PubMed 33130139Sale D. Single versus Double Burr Hole for Drainage of Chronic Subdural Hematoma: Randomized Controlled Study. World Neurosurg. 2021 Feb;146:e565-e567. doi: 10.1016/j.wneu.2020.10.140. Epub 2020 Oct 28.
- Individual participant dataSharing planned: Undecided
Related trials for Chronic Subdural Hematoma
RecruitingObservational study
Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence
Chronic Subdural Hematoma
Recruiting
Middle Meningeal Artery Embolisation in Chronic Subdural Hematoma
Chronic Subdural Hematoma
Not yet recruitingPhase 4
Propofol Target-Controlled Infusion Versus Dexmedetomidine for Sedation During Chronic Subdural Hematoma Surgery Under Local Anesthesia
Chronic Subdural Hematoma
RecruitingObservational study
Study On Histoacryl Used For Embolization Of Middle Meningeal Artery (MMA) In Chronic Subdural Hematoma (CSDH)
Subdural Hematoma, Subdural Hematoma, Chronic
Recruiting
MMA Embolization With NeoCast for Subacute and Chronic Subdural Hematoma
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chronic Subdural Hematoma Evacuation in people with Chronic Subdural Hematoma, run by Sohag University at 1 site in Egypt.
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 5 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: under way, not looking for participants, as of the sponsor's last update on 7 Jul 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 Egypt. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence (time frame: 6 months). 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 NCT07688473, 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 7 Jul 2026.