Tranexamic Acid in Chronic Subdural Hematomas

Launched by CENTRE DE RECHERCHE DU CENTRE HOSPITALIER UNIVERSITAIRE DE SHERBROOKE · Oct 1, 2015

Keywords

ClinConnect Summary

The TRACS trial is studying whether a medication called Tranexamic Acid (TXA) can help people with chronic subdural hematomas (CSDH), which are collections of blood on the brain that can cause serious problems. This trial aims to find out if TXA can help these blood collections go away faster, reduce the need for surgeries, and lower the chances of them coming back after surgery. The trial will involve about 130 patients who have been diagnosed with CSDH within the last two weeks. To participate, patients must meet certain criteria, such as having a CT scan that shows their condition and not having specific health issues that could complicate their treatment.

Participants will receive either TXA or a placebo (an inactive treatment) for up to 20 weeks, during which their CSDH will be monitored through regular CT scans. They will also complete tests to assess their cognitive function, quality of life, and daily living skills at the start of the study and during follow-ups. The trial is designed to be safe and to gather valuable information that could lead to a larger study in the future. It is important to know that this is the first study looking at TXA for CSDH, and it could pave the way for new treatments for this condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • CT scan demonstrating the existence of a subdural hematoma containing a chronic component
• • Diagnosis within the last 14 days
• Exclusion Criteria:
• • Acute subdural hematoma with no chronic component;
• • Active thrombotic, thromboembolic or atheroembolic disease, including deep venous thrombosis within the last six months, cerebral thrombosis within the last six months, symptomatic carotid stenosis who did not undergo surgery or stroke within the last year;
• • Past history of unprovoked deep venous thrombosis or idiopathic pulmonary embolism;
• • Known hereditary thrombophilia, including Factor V Leiden, Antithrombin III mutation, Protein C deficiency, Protein S deficiency;
• • Atrial fibrillation (unless under successful rhythm control therapy);
• • Metallic heart valve;
• • Vascular stenting procedure within the last year;
• • Cardiac or vascular surgical procedure within the last 6 months, including endarterectomy, bypass or angioplasty;
• • Ongoing investigation for suspected malignancy;
• • Confirmed active malignancy;
• • Concomitant hormone therapy for malignancy;
• • Concomitant hormone contraceptive pill;
• • Macroscopic hematuria;
• • Known or suspected tranexamic acid allergy;
• • Pregnancy or breastfeeding;
• • Concomitant use of anticoagulant medication;
• • Any concern from the attending physician.