RECRUITINGPhase 2 / Phase 3INTERVENTIONAL

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

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Symptomatic chronic subdural hematoma confirmed on computer tomography (CT) or magnetic resonance imaging (MRI) measuring greater than 10 mm thickness. 2. Adult patient ≥18 years 3. Scheduled for single or double burr hole for evacuation. 4. No contraindication for TXA Exclusion criteria 1. Mechanical heart valve 2. Newly diagnosed (last 12 months) pulmonary embolism, myocardial infarction, and strong indication for antithrombotic treatment 3. Intracranial surgery within last 6 months 4. Pregnancy and woman\<40 years 5. Participation in any other clinical trial 6. Life expectancy of less than one year. 7. 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. 8. Unfit for participations for any other reason as evaluated by the including physician. 9. History of severe impairment of renal function (eGFR \<30ml/min or serum creatinine \>150μmol/L) 10. Known hypersensitivity or allergy to TXA 11. Inability to obtain willing to sign a consent form from the patient or legal representative Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Symptomatic chronic subdural hematoma confirmed on computer tomography (CT) or magnetic resonance imaging (MRI) measuring greater than 10 mm thickness. 2. Adult patient ≥18 years 3. Scheduled for single or double burr hole for evacuation. 4. No contraindication for TXA Exclusion criteria 1. Mechanical heart valve 2. Newly diagnosed (last 12 months) pulmonary embolism, myocardial infarction, and strong indication for antithrombotic treatment 3. Intracranial surgery within last 6 months 4. Pregnancy and woman\<40 years 5. Participation in any other clinical trial 6. Life expectancy of less than one year. 7. 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. 8. Unfit for participations for any other reason as evaluated by the including physician. 9. History of severe impairment of renal function (eGFR \<30ml/min or serum creatinine \>150μmol/L) 10. Known hypersensitivity or allergy to TXA 11. Inability to obtain informed consent from the patient or legal representative

Treatments Being Tested

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

Locations (1)

Post Graduate Institute of Medical Education & Research

Chandigarh, India