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Adjuvant Tranexamic Acid (TXA) Versus Surgery Alone for Adult Patients With Chronic Subdural Hematoma (CSDH)

NCT07245264 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 274

Last updated 2025-12-08

No results posted yet for this study

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.

Conditions

  • Chronic Subdural Hematoma

Interventions

DRUG

Tranexamic Acid (Cyklokapron)

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

Sponsors & Collaborators

  • Post Graduate Institute of Medical Education and Research, Chandigarh

    collaborator OTHER

  • St. Olavs Hospital

    lead OTHER

Principal Investigators

  • Chandrashekhar Gendle, MD PhD · Postgraduate Institute of Medical Education & Research (PGIMER)

  • Mattis A Madsbu, MD PhD · St. Olavs University Hospital, Department of Neurosurgery

  • Sasha Gulati, Professor · St. Olavs University Hospital, Department of Neurosurgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-10
Primary Completion
2028-11-01
Completion
2029-06-01

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07245264 on ClinicalTrials.gov