Tranexamic Acid Therapy For The Treatment of Subdural Hematomas

Launched by BAYLOR COLLEGE OF MEDICINE · Dec 2, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Tranexamic Acid (TXA) to see if it can help treat chronic subdural hematomas (cSDH), which are collections of blood on the brain that have been present for a long time. The trial will involve patients who do not need surgery for their cSDH. Participants will be randomly assigned to either take TXA or a placebo (a pill with no active medication) for 21 weeks. Throughout the study, patients will have regular check-ups that include neurological tests and imaging to monitor their condition.

To be eligible for this trial, patients must have a CT scan showing a chronic subdural hematoma and must be evaluated by a neurosurgeon who determines that surgery is not necessary. They should also be able to take the medication correctly or have someone who can help them. However, individuals who require surgery, have certain medical conditions, or are pregnant or breastfeeding will not be eligible to participate. This trial aims to find out if TXA is a safe and effective way to manage cSDH without surgery, potentially improving outcomes for patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • CT scan demonstrating existence of a subdural hematoma, unilateral or bilateral, containing a chronic component
• • Neurosurgeon evaluation deemed patient to not need surgery
• • Diagnosis within the last 14 days
• • Signed informed consent
• • Competence to take study medications properly and regularly or access to care giver that is able to comply with accurate study medication administration
• Exclusion Criteria:
• • Planned surgery, burr-hole craniostomy or mini-craniotomy for their chronic subdural hematoma based on one or more of the following symptoms: medically intractable headache, midline shift \>5mm, SDH thickness \>10mm, increased ICP, imminent death within 24 hours
• • Structural causes for subdural hemorrhage (arachnoid cysts, cortical vascular malformations)
• • Recent ischemic stroke
• • Other concomitant intracranial pathology (intracranial malignancy)
• • Active malignancy
• • Need for chronic therapeutic anticoagulation (i.e. atrial fibrillation)
• • Acute subdural hematoma with no chronic component
• • Active treatment for deep vein thrombosis, pulmonary embolism or cerebral thrombosis (secondary prophylaxis is not considered to be active treatment)
• • Known hereditary thrombophilia, including Factor V Leiden, Antithrombin III mutation, Protein C deficiency, Protein S deficiency
• • History of thrombosis or thromboembolism, including retinal vein or artery occlusions
• • An intrinsic risk of thrombosis or thromboembolism
• • Aneurysmal subarachnoid hemorrhage
• • Concurrent use of Factor IX complex concentrate or anti-inhibitor coagulant concentrates
• • Concurrent use of all-trans retinoic acid
• • Active intravascular clotting or disseminated intravascular coagulation
• • Need for tissue plasminogen activators
• • Known hypersenstivity to TXA or any of the ingredients
• • Acute and chronic renal insufficiency indicated by glomerular filtration rate (GFR) \< 60 mL/min or creatinine \> 2.8 mg/dL
• • Hematuria, caused by diseases of renal parenchyma
• • Pregnancy or breastfeeding\*
• • Concomitant hormonal contraception\*
• • History of convulsions
• • History of angioplasty with cardiac stent placement or mechanical heart valve
• • Any concern from the attending physician