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โ† Trials
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Tranexamic Acid to Prevent OpeRation in Chronic Subdural Hematoma

RecruitingPhase 3Ages 50 Years - anyAllAcademisch Medisch Centrum - Universiteit van Amsโ€ฆ
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In plain words

What the trial is, and whether it could suit you

Rationale: Chronic subdural hematoma (cSDH) is a frequently occurring disease, occurring mainly in the elderly. Surgical evacuation is effective, but also associated with life-threatening risks. In these old, often frail, patients with multi-comorbidity, surgery also comes with significant risks for future cognitive functioning and therefore, loss of independency. In five small retrospective series, tranexamic acid (TXA), an antifibrinolytic drug, showed a beneficial effect on the spontaneous resolution of the hematoma and, with that, the necessity for surgery. This randomised, placebo-controlled clinical trial aims to prove the efficacy of TXA. Objectives: Primarily to evaluate the efficacy of TXA to prevent surgery for cSDH. Secondarily to evaluate the efficacy of TXA to reduce cSDH volume, neurological impairment (mNIHSS), the incidence of falling incidents, the mortality rate, the u

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 \>150ฮผmol/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;
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What it tests

  • Tranexamic Acid 500Mg Tablet
  • Placebo oral capsule
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Where

1 site
Academic Medical Center
Amsterdam, Netherlands
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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