Randomized Trial Comparing Adjuvant Tranexamic Acid Versus Surgery Alone For Chronic Subdural Hematoma

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Symptomatic chronic subdural hematoma confirmed on computer tomography (CT) or magnetic resonance imaging (MRI) measuring greater than 10 mm thickness.

• Adult patient ≥18 years

• Scheduled for single or double burr hole for evacuation.

• No contraindication for TXA

Locations
Other Locations
India
Post Graduate Institute of Medical Education & Research
RECRUITING
Chandigarh
Contact Information
Primary
Chandrashekhar Gendle, MD PhD
chandrashekhargonde@gmail.com
+91 98781 52589
Backup
Pravin Salunke, Professor, MD
drpravin_salunke@yahoo.co.uk
+91 99155 04994
Time Frame
Start Date: 2025-12-10
Estimated Completion Date: 2029-06-01
Participants
Target number of participants: 274
Treatments
Active_comparator: Standard surgical treatment with adjunctive treatment with tranexamic acid
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.
No_intervention: Standard surgical treatment
Surgically evacuation of chronic subdural hematoma without adjuntive medical therapy
Sponsors
Leads: St. Olavs Hospital
Collaborators: Post Graduate Institute of Medical Education and Research, Chandigarh

This content was sourced from clinicaltrials.gov

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