CompletedPhase 4

Use of Tissue Plasminogen Activator in the Clearance of Chronic Subdural Hematomas

Canada40 participantsStarted 2023-05-11

Plain-language summary

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.

Who can participate

Age range18 Years – 100 Years

SexALL

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Inclusion criteria

✓. Adult patients (18 yrs or older)
✓. Admitted to neurosurgery wing at the hospital
✓. Symptomatic patients requiring surgical drainage by twist drill craniostomy

Exclusion criteria

✕. Patients at increased risk of bleeding such as patients taking anticoagulation medication that required reversal at time of intervention، or those with coagulopathic disorder.
✕. 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.
✕. Patients with subdural empyema.
✕. Redo twist drill craniostomy for residual cSDH within the same admission.
✕. Drain accidentally removed during nursing care or patient transport before 24 hr interval scan.
✕. Patients who are not expected to live more than three months.

What they're measuring

Study Feasibility

Timeframe: 8 months

Trial details

NCT IDNCT05491356

SponsorHamilton Health Sciences Corporation

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03-30

View on ClinicalTrials.gov More Hematoma, Subdural trials