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

NCT07245264 | Recruiting Phase 2 DMC

• 1 other identifier: CHG-090891
• Study Type: interventional
• Target: 274
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Chronic subdural hematoma; Tranexamic acid; Neurosurgery

Outcome Measures

Primary Outcomes (1)

• 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

  90 days

Secondary Outcomes (5)

• Functional outcome

  90 days

• Health-related Quality Of Life

  90 days

• Headache

  90 days

• Complications and adverse events

  90 days

• Mortality

  90 days

Study Arms (2)

Standard surgical treatment with adjunctive treatment with tranexamic acid

ACTIVE COMPARATOR

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)

Standard surgical treatment

NO INTERVENTION

Surgically evacuation of chronic subdural hematoma without adjuntive medical therapy

Interventions

Tranexamic Acid (Cyklokapron) DRUG

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

Standard surgical treatment with adjunctive treatment with tranexamic acid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Mechanical heart valve
• Newly diagnosed (last 12 months) pulmonary embolism, myocardial infarction, and strong indication for antithrombotic treatment
• Intracranial surgery within last 6 months
• Pregnancy and woman\<40 years
• Participation in any other clinical trial
• Life expectancy of less than one year.
• A score on the modified Rankin scale, designed to assess functional independence, of 4 or 5 (scores range from 0 \[no symptoms\] to 6 \[death\]) before the hematoma occurred.
• Unfit for participations for any other reason as evaluated by the including physician.
• History of severe impairment of renal function (eGFR \<30ml/min or serum creatinine \>150μmol/L)
• Known hypersensitivity or allergy to TXA
• Inability to obtain informed consent from the patient or legal representative

Sponsors & Collaborators

• St. Olavs Hospital: lead
• Post Graduate Institute of Medical Education and Research, Chandigarh: collaborator

Study Sites (1)

Post Graduate Institute of Medical Education & Research

Chandigarh, 160012, India

RECRUITING

MeSH Terms

Conditions

Hematoma, Subdural, Chronic

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Hematoma, Subdural; Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematoma; Hemorrhage; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Chandrashekhar Gendle, MD PhD

  Postgraduate Institute of Medical Education & Research (PGIMER)

  STUDY CHAIR

• Mattis A Madsbu, MD PhD

  St. Olavs University Hospital, Department of Neurosurgery

  PRINCIPAL INVESTIGATOR

• Sasha Gulati, Professor

  St. Olavs University Hospital, Department of Neurosurgery

  STUDY CHAIR

Central Study Contacts

Chandrashekhar Gendle, MD PhD

CONTACT

+91 98781 52589; chandrashekhargonde@gmail.com

Pravin Salunke, Professor, MD

CONTACT

+91 99155 04994; drpravin_salunke@yahoo.co.uk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 24, 2025
• Study Start: December 10, 2025
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)