Using Tranexamic Acid to Prevent Surgery for Chronic Subdural Hematoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Academic Medical Center
  Amsterdam, Netherlands Recruiting

Study contacts

• Study coordinator: William P Vandertop, MD PhD
• Email: w.p.vandertop@amsterdamumc.nl
• Phone: +31205669111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.