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:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
NCT ID:
NCT03280212
Eligibility Criteria:
Inclusion Criteria:
* Patients diagnosed with chronic subdural hematoma, and have a planned or have received a unilateral or bilateral burr-hole craniostomy or mini-craniotomy
* Written informed consent (patient, power of attorney or substitute decision maker)
* Competence to take study medication properly and regularly or access to care giver that is able to comply with accurate study medication administration
Exclusion Criteria:
* Hypersensitivity to TXA or any of the ingredients
* Pregnancy
* Irregular menstrual bleeding with unidentified cause
* Acquired colour vision disturbances
* Acute and chronic renal insufficiency indicated by glomerular filtration rate (GFR) ≤ 30 mL/min
* Hematuria, caused by diseases of renal parenchyma
* Current alcohol abuse (as indicated by an Alcohol Use Disorders Identification Test (AUDIT) score of 10 or higher) drug abuse, or recreational drug use
* Concomitant intake of hormonal contraceptives, factor IX complex concentrates, and anti-inhibitor coagulant concentrates (factor VII, activated factor IX)
* Active, history, or increased risk of thrombotic events (including deep vein thrombosis, pulmonary embolism, cerebral venous thrombosis, arterial thrombotic events), symptomatic carotid stenosis, myocardial infarction, acute coronary syndrome, coronary artery disease, or consumption coagulopathy within the past 2 years
* History of angioplasty with cardiac stent placement or mechanical heart valve
* Active or history of brain pathologies such as stroke (hemorrhagic and ischemic), subarachnoid hemorrhage, or malignant brain tumors (glioma, metastasis and others) as well as history of seizures within the past 2 years
* Contraindication to stopping full therapeutic doses of non-acetylsalicylic acid (ASA) antiplatelets, warfarin, rivaroxaban, apixaban, dabigatran, or other anticoagulant for 2 weeks after surgery
* Patients requiring immediate revision surgery (as defined by attending surgeon)
* Inability of oral drug intake or missing support to guarantee oral drug intake
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03280212
Study Brief:
Protocol Section:
NCT03280212