Actively Recruiting
Adjuvant Tranexamic Acid (TXA) Versus Surgery Alone for Adult Patients With Chronic Subdural Hematoma (CSDH)
Led by St. Olavs Hospital · Updated on 2025-12-08
274
Participants Needed
1
Research Sites
181 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
This study is an open label randomized controlled trial. Patients with a symptomatic Chronic Subdural Hematoma (CSDH) confirmed on radiological imaging, planned for surgery, age over 18, free from other intracranial pathologies and no previous intracranial surgery, will be recruited at time of admission. Patients eligible for inclusion will be randomized to receive treatment with Tranexamic acid (TXA) as an adjunct to surgery or surgery alone. Surgical evacuation will be performed using a single or double burr hole and 24 hours postoperative drainage. The primary endpoint will be recurrent hematoma requiring repeat surgery within 90 days. Secondary outcomes will be modified Rankin Scale at 90 days, EQ-5D-5L, complications and adverse events, and 90-day mortality.
CONDITIONS
Official 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
- Adults aged 18 years or older
- Scheduled for single or double burr hole evacuation surgery
- No contraindications for tranexamic acid (TXA) treatment
You will not qualify if you...
- Presence of mechanical heart valve
- Pulmonary embolism or myocardial infarction diagnosed within the last 12 months requiring antithrombotic treatment
- Intracranial surgery within the last 6 months
- Pregnancy or 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 occurrence
- Unfit for participation as judged by the physician
- Severe kidney impairment (eGFR less than 30 ml/min or serum creatinine above 150 µmol/L)
- Known allergy or hypersensitivity to tranexamic acid
- Inability to provide informed consent or have a legal representative provide consent
AI-Screening
AI-Powered Screening
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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
CONTACT
P
Pravin Salunke, Professor, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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