Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2025-12-24 @ 11:41 PM
NCT ID:
NCT06718751
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
95 Years
Study:
NCT06718751
Study Brief:
Protocol Section:
NCT06718751