Chronic Subdural HematomaNCT07368101
Outcome of Chronic Subdural Hematoma Management With Double Burr Hole Craniotomy Versus Single Burr Hole Craniotomy and Subdural Drain Evacuation
A study testing Single Burr hole Craniotomy and Double Burr hole Craniotomy in people with Chronic Subdural Hematoma, run by Services Institute of Medical Sciences, Pakistan at 1 site in Pakistan.
Trial summary
The goal of this clinical trial is to compare the outcome of double burr hole versus single burr hole in patients of chronic subdural hematoma undergoing subdural drain evacuation. The main questions it aims to answers are 1. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Chronic Subdural Hematoma
- What is being tested?
- Single Burr hole Craniotomy and Double Burr hole Craniotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 4 Oct 2024to 9 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 20-70 years both genders diagnosed with subdural hematoma
Who cannot join
- • Patients in shock (BP≤100/60 mmHg) or history of seizures
- Patients with bleeding disorder (PT>15 sec) or intake of anti-coagulants
- Patients undergoing or already had ventriculoperitoneal shunt
- Patients with epilepsy, or obsessive compulsive decoder
- Patients with already operated for subdural hematoma
- Patients with post-cerebrospinal fluid diversion subdural hematoma
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Services Institute of Medical Sciences / Services Hospital
Lahore, Punjab Province, 54770
About this study
Official title: Outcome of Chronic Subdural Hematoma: Double Burr Hole Versus Single Burr Hole With Subdural Drain Evacuation
The goal of this clinical trial is to compare the outcome of double burr hole versus single burr hole in patients of chronic subdural hematoma undergoing subdural drain evacuation.
The main questions it aims to answers are
Read more
- Which one of the surgical method i.e single burr hole or double burr hole is clinically superior with better post operative prognosis for the drainage of chronic subdural hematoma.
2 Compare the post operative complications in both the techniques in term of wound infection hospital stay duration , recurrence and mortality.
participants will be divided in two groups one group will be treated with single burr hole technique second group will be treated with double burr hole technique.
After procedure, patients will be followed-up in hospital until discharge and total hospital stay will be noted. Patients will be followed-up further in OPD . During follow-up, patients will be evaluated for wound infection, recurrence and mortality.
- Conditions
- Chronic Subdural Hematoma
- Being tested
- Single Burr hole Craniotomy, Double Burr hole Craniotomy
- 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.
Single Burr hole CraniotomyProcedure or surgery
Single Burr hole made at the point of highest collection of hematoma in subdural space in brain.
Double Burr hole CraniotomyProcedure or surgery
Two burr hole made in skull each at parietal eminence and around superior temporal line to drain chronic subdural hematoma
| Study group | Role | What they receive |
|---|---|---|
| Double burr Hole Arm | Experimental | this arm includes patient who receive double burr hole craniotomy surgical procedure for drainage of chronic subdural hematoma Receives: Procedure: Double Burr hole Craniotomy |
| Single Burr Hole Arm | Experimental | this arm includes patient who receive single burr hole craniotomy surgical procedure for drainage of chronic subdural hematoma Receives: Procedure: Single Burr hole Craniotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence Of Chronic Subdural Hematoma
recurrence rate of chronic subdural hematoma evaluated if volume of sdh >15ml or significant mass effect on CT brain within 3 months post operatively
Measured: From date of surgery until radiologically confirmed recurrence (defined as subdural hematoma volume >15 mL or significant mass effect on CT brain) requiring repeat intervention, assessed up to 3 months postoperatively
quantity of hematoma evacuated
Intraoperatively evacuated hematoma quantity measured in millilitres and also includes the quantity obtained in subdural drain till 72 hours postoperatively
Measured: Measured intraoperatively at the time of surgery and cumulatively measured postoperatively from surgery until removal of the subdural drain, assessed up to 72 hours postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start4 Oct 2024
- Primary completion7 Mar 2025
- Study completion9 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Services Institute of Medical Sciences, Pakistan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Muhammad Hassan tabish, Services Institute of Medical Sciences, Pakistan
- Investigators
- Muhammad Hassan Tabish, MBBS, Principal investigator, Services Hospital / Services Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07368101
- Sponsor's protocol ID
- IRB/2024/1395/SIMS
- Status last verified
- Jan 2026
- First submitted
- 12 Jan 2026
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Chronic Subdural Hematoma: Double Burr Hole Versus Single Burr Hole With Subdural Drain Evacuation
- ClinicalTrials.gov ID
- NCT07368101
- Acronym / sponsor ID
- IRB/2024/1395/SIMS
- Conditions
- Chronic Subdural Hematoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Services Institute of Medical Sciences, PakistanOther government
- Study start
- 4 Oct 2024 (actual)
- Primary completion
- 7 Mar 2025 (actual)
- Study completion
- 9 May 2025 (actual)
- First posted
- 26 Jan 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.
The goal of this clinical trial is to compare the outcome of double burr hole versus single burr hole in patients of chronic subdural hematoma undergoing subdural drain evacuation.
The main questions it aims to answers are
- Which one of the surgical method i.e single burr hole or double burr hole is clinically superior with better post operative prognosis for the drainage of chronic subdural hematoma.
2 Compare the post operative complications in both the techniques in term of wound infection hospital stay duration , recurrence and mortality.
participants will be divided in two groups one group will be treated with single burr hole technique second group will be treated with double burr hole technique.
After procedure, patients will be followed-up in hospital until discharge and total hospital stay will be noted. Patients will be followed-up further in OPD . During follow-up, patients will be evaluated for wound infection, recurrence and mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Double burr Hole Arm | Experimental | Procedure: Double Burr hole Craniotomythis arm includes patient who receive double burr hole craniotomy surgical procedure for drainage of chronic subdural hematoma |
| Single Burr Hole Arm | Experimental | Procedure: Single Burr hole Craniotomythis arm includes patient who receive single burr hole craniotomy surgical procedure for drainage of chronic subdural hematoma |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 20-70 years both genders diagnosed with subdural hematoma
Key exclusion criteria (6 listed)
- • Patients in shock (BP≤100/60 mmHg) or history of seizures
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 |
|---|---|---|
| Single Burr hole CraniotomySingle Burr hole made at the point of highest collection of hematoma in subdural space in brain. | Procedure or surgery | Single Burr Hole Arm |
| Double Burr hole CraniotomyTwo burr hole made in skull each at parietal eminence and around superior temporal line to drain chronic subdural hematoma | Procedure or surgery | Double burr Hole Arm |
Primary outcome
Recurrence Of Chronic Subdural Hematoma
Time frame: From date of surgery until radiologically confirmed recurrence (defined as subdural hematoma volume >15 mL or significant mass effect on CT brain) requiring repeat intervention, assessed up to 3 months postoperatively
recurrence rate of chronic subdural hematoma evaluated if volume of sdh >15ml or significant mass effect on CT brain within 3 months post operatively
quantity of hematoma evacuated
Time frame: Measured intraoperatively at the time of surgery and cumulatively measured postoperatively from surgery until removal of the subdural drain, assessed up to 72 hours postoperatively.
Intraoperatively evacuated hematoma quantity measured in millilitres and also includes the quantity obtained in subdural drain till 72 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Muhammad Hassan Tabish, MBBS principal investigator
Services Hospital / Services Institute of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single Burr hole Craniotomy and Double Burr hole Craniotomy in people with Chronic Subdural Hematoma, run by Services Institute of Medical Sciences, Pakistan at 1 site in Pakistan.
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 1 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: finished, as of the sponsor's last update on 26 Jan 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 Pakistan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Of Chronic Subdural Hematoma (time frame: From date of surgery until radiologically confirmed recurrence (defined as subdural hematoma volume >15 mL or significant mass effect on CT brain) requiring repeat intervention, assessed up to 3 months postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jan 2026.