Actively Recruiting
Randomized Trial Comparing Adjuvant Tranexamic Acid Versus Surgery Alone For Chronic Subdural Hematoma
Led by St. Olavs Hospital · Updated on 2025-12-08
274
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
Sponsors
S
St. Olavs Hospital
Lead Sponsor
P
Post Graduate Institute of Medical Education and Research, Chandigarh
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of tranexamic acid (TXA) as an additional treatment to surgery for adults with symptomatic Chronic Subdural Hematoma (CSDH), a condition where blood collects on the brain's surface. This trial aims to see if adding TXA can reduce the chance of the hematoma returning after surgery. The study is a randomized controlled trial conducted at a single center, focusing on patients over 18 who are planned for surgical evacuation and have no other brain conditions or prior brain surgeries. Participants are randomly assigned to one of two groups: one receives standard surgery plus TXA, and the other receives surgery alone. Those in the TXA group get 1 gram of the drug intravenously before surgery, another 1 gram after surgery, and then continue with 500 mg twice daily by mouth for four weeks. Surgery is performed using one or two burr holes with drainage for 24 hours after the operation. The study tracks participants for 90 days to monitor for hematoma recurrence requiring repeat surgery and other health outcomes. Throughout the study, participants undergo imaging tests like CT or MRI scans at the start, after surgery, and at follow-up visits around four and possibly twelve weeks. Researchers also assess functional independence, quality of life, headache symptoms, complications, and mortality up to 90 days after surgery. Safety monitoring includes watching for blood clot-related side effects. The total participation duration covers the initial treatment and follow-up period, ensuring careful observation of outcomes and adverse events.
CONDITIONS
Brief Title
Adjuvant Tranexamic Acid (TXA) Versus Surgery Alone for Adult Patients With Chronic Subdural Hematoma (CSDH)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Symptomatic chronic subdural hematoma confirmed on CT or MRI measuring greater than 10 mm thickness
- Adult patient aged 18 years or older
- Scheduled for single or double burr hole evacuation
- No contraindication for tranexamic acid
You will not qualify if you...
- Mechanical heart valve
- Recent pulmonary embolism, myocardial infarction, or strong indication for antithrombotic treatment within the last 12 months
- Intracranial surgery within the last 6 months
- Pregnancy and women under 40 years old
- Participation in any other clinical trial
- Life expectancy less than one year
- Modified Rankin scale score of 4 or 5 before hematoma occurred
- Unfit for participation as evaluated by the physician
- Severe kidney impairment (eGFR less than 30 ml/min or serum creatinine over 150 µmol/L)
- Known allergy or hypersensitivity to tranexamic acid
- Inability to provide informed consent from patient or legal representative
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants undergo surgical evacuation of chronic subdural hematoma. Those in the treatment group receive tranexamic acid before and after surgery, followed by oral tranexamic acid twice daily for 4 weeks.
1 surgery visit and weekly visits for up to 4 weeks
Duration - Up to 90 days after surgery
Participants are monitored for recurrence of hematoma, functional outcomes, quality of life, and adverse events up to 90 days after surgery.
Imaging assessments at post-operative, week 4, and possibly week 12 visits
Trial Site Locations
Total: 1 location
1
Post Graduate Institute of Medical Education & Research
Chandigarh, India, 160012
Actively Recruiting
Research Team
C
Chandrashekhar Gendle, MD PhD
P
Pravin Salunke, Professor, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here