A Phase 2/3 interventional study of Tranexamic Acid (Cyklokapron) in Chronic Subdural Hematoma, sponsored by St. Olavs Hospital. Recruiting at 1 site in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-17.
Sponsored by St. Olavs Hospital · Phase 2/3, Interventional, and Treatment
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.
This study is a prospective single-center open-label randomized controlled trial (RCT) investigating whether the administration of tranexamic acid (TXA) as an adjuvant to surgery reduces the recurrence rate of chronic subdural hematoma (CSDH) compared to surgery alone.
CSDH is a frequent neurosurgical condition, especially among elderly patients, and carries a substantial risk of recurrence after surgical evacuation. Despite standardized procedures such as burr hole drainage and postoperative irrigation with 24-hour drainage, reoperation rates remain high (5-20%). There is currently a need for adjunctive therapies to reduce recurrence and improve clinical outcomes.
Tranexamic acid is a well-established antifibrinolytic agent that inhibits plasminogen activation and stabilizes blood clots. While observational studies and limited randomized trials have suggested a potential benefit of TXA in CSDH patients, conclusive evidence remains lacking.
This trial (RATATA) randomly assigns eligible adult patients with symptomatic CSDH confirmed via CT or MRI to receive either standard surgical treatment or surgery plus adjuvant TXA. Participants in the intervention arm receive a total of 2g IV TXA (1g \<12h pre-op and 1g 12h post-op) and continue with oral TXA 500 mg twice daily for four weeks.
The primary endpoint is recurrence of the ipsilateral CSDH requiring repeat surgery within 90 days of the index operation. Recurrence is defined by both clinical deterioration and radiologically confirmed hematoma. Secondary endpoints include functional outcomes measured by the Modified Rankin Scale (mRS), health-related quality of life assessed using EQ-5D-5L, complication and adverse event rates, and 90-days mortality.
Imaging assessments will be conducted at baseline and during follow-up (post-operatively, week 4 and at surgeons´ discretion 12 weeks if indicated). The study also includes robust safety monitoring for thromboembolic and other TXA-related adverse events.
Randomization is stratified by age (≥60 vs. \<60) and gender using a computer-generated block randomization scheme. Allocation concealment is ensured via sealed opaque envelopes, and outcomes assessors for imaging and functional scores are blinded to treatment assignment.
Sample size was calculated to detect a 12% absolute reduction in recurrence (from 18% to 6%), requiring 274 patients (137 per group) with 80% power and a two-sided alpha of 0.05, accounting for a 20% loss to follow-up.
The study follows Good Clinical Practice guidelines and the Declaration of Helsinki.
114 studies on the registry are indexed under Hematoma, Subdural, Chronic; 48 are open to participants now.
This study's planned enrollment of 274 is above the median of 164 across 87 interventional studies indexed under Hematoma, Subdural, Chronic.
Browse Hematoma, Subdural, Chronic studies →St. Olavs Hospital is the lead sponsor of 165 studies on the registry; 30 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria
Surgical evacuation with tranexamic acid. Preoperative administration of 1g IV with additional 1g administrated postoperatively. Followed by 500mg two times a day for a total of 28 days.
Drug: Tranexamic Acid (Cyklokapron)
Surgically evacuation of chronic subdural hematoma without adjuntive medical therapy
Patients randomized to the treatment group will receive 1g of TXA pre and postoperative intravenously administrated followed by a 28 days treatment course of 500mg x2 of TXA orally
Recurrence of symptomatic chronic subdural hematoma requiring repeat surgery within 90 days
Number of patients with a radiological and clinical significant recurrent hematoma withing 90 days
Time frame: 90 days
Functional outcome
Functional outcome measured with the modified Rankin Scale (mRS) score, range 0 (no symptoms) to 6 (death)
Time frame: 90 days
Health-related Quality Of Life
Change from baseline in generic health-related quality of life measured with the five dimensional EuroQol questionnaire (EQ-5D-L)
Time frame: 90 days
Headache
Change in headache intensity measured with numerical rating scale (1-10)
Time frame: 90 days
Complications and adverse events
Complications and adverse events
Time frame: 90 days
Mortality
Mortality
Time frame: 90 days
Plan to share: No
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