The Utility of Intra-Catheter Fibrinolytics in Draining Chronic Subdural Hematomas: A Randomized Controlled Trial Pilot Study

14724

To determine the utility of tissue plasminogen activator (tPA) in the clearance of chronic subdural hematomas (CSDH). Intra-catheter tPA will be administered during surgical procedure and allowed to break down blood clot to assist with removal/drainage during twist drill craniostomy procedure.

2023-05-11

2024-06-30

2024-07-30

Recruiting

Early phase I

40

Inclusion Criteria: 1. Adult patients (18 yrs or older) 2. Admitted to neurosurgery wing at the hospital 3. Symptomatic patients requiring surgical drainage by twist drill craniostomy Exclusion Criteria: 1. Patients at increased risk of bleeding such as patients taking anticoagulation medication that required reversal at time of intervention، or those with coagulopathic disorder. 2. Patients on antiplatelets or anticoagulation medications (DOACs or warfarin) with appropriate holding period prior to drainage, those who are eventually minimized to a regular bleeding risk compared to the normal population, will be included in the study. 3. Patients with subdural empyema. 4. Redo twist drill craniostomy for residual cSDH within the same admission. 5. Drain accidentally removed during nursing care or patient transport before 24 hr interval scan. 6. Patients who are not expected to live more than three months.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}

2024-03-28