Using Tranexamic Acid to Prevent Surgery for Chronic Subdural Hematoma

Tranexamic Acid to Prevent OpeRation in Chronic Subdural Hematoma. A Double-blind, Placebo-controlled, Multicentre, Randomized Controlled Clinical Trial

This study is testing if tranexamic acid can help older patients with chronic subdural hematoma avoid surgery and improve their overall health.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 554 (estimated)
• Ages: 50 Years and up
• Sex: All
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Academic / other)
• Locations: 1 site (Amsterdam)
• Trial ID: NCT03582293 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of tranexamic acid (TXA), an antifibrinolytic agent, in preventing the need for surgical intervention in patients with chronic subdural hematoma (cSDH). The study is randomized and placebo-controlled, focusing on elderly patients who are at risk for surgery-related complications. It aims to evaluate not only the necessity for surgery but also the impact of TXA on hematoma volume, neurological function, and overall health outcomes. The trial will assess various secondary endpoints, including cognitive functioning and healthcare costs associated with treatment.

Who should consider this trial

Good fit: Ideal candidates for this study are elderly patients diagnosed with chronic subdural hematoma who are stable and not requiring immediate surgical intervention.

Not a fit: Patients with severe symptoms requiring immediate surgical treatment or those with contraindications to tranexamic acid will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the need for surgery in elderly patients with chronic subdural hematoma, thereby minimizing associated risks and improving quality of life.

How similar studies have performed: Previous smaller studies have shown promising results with tranexamic acid in similar contexts, suggesting potential efficacy, though this trial aims to provide more definitive evidence.

Eligibility criteria

Inclusion Criteria:

* On CT confirmed cSDH
* Primary conservative treatment, based on clinical symptoms: Glasgow Coma Scale score \>=14, mNIHSS score \<=4 and a stable neurological deficit (no new, or progression of, symptoms between the assessment by the neurologist and the assessment by the neurosurgeon).

Exclusion Criteria:

Primary surgical treatment based on one or more of the following symptoms or parameters: medically intractable headache, midline shift \>10mm, imminent death within 24 hours;

* Structural causes for subdural haemorrhage, e.g. arachnoid cysts, cortical vascular malformations and a history of cranial surgery \<1year;
* Aneurysmal subarachnoid haemorrhage;
* Active treatment for deep vein thrombosis, pulmonary embolism or cerebral thrombosis (secondary prophylaxis is not considered to be active treatment);
* Active intravascular clotting or disseminated intravascular coagulation;
* Known hypersensitivity or allergy to TXA or to any of the ingredients;
* History of a blood coagulation disorder (hypercoagulability disorder);
* History of severe impairment of renal function (eGFR \<30ml/min or serum creatinine \>150μmol/L);
* History of anaemia (haemoglobin \<6mmol/L);
* History of convulsions;
* History of inability to safely swallow oral medication.
* Inability to obtain informed consent from the patient or legal representative (when the patient has a depressed level of consciousness as described in paragraph 11.2), including language barrier;

Where this trial is running

Amsterdam

• Academic Medical Center — Amsterdam, Netherlands (Recruiting)

Study contacts

• Study coordinator: William P Vandertop, MD PhD

Conditions Hematoma, Subdural, Chronic; Tranexamic Acid; Antifibrinolytic Agents