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

Last updated: March 14, 2025
Sponsor: Hamilton Health Sciences Corporation
Overall Status: Completed

Phase

4

Condition

Hemorrhage

Treatment

Tissue Plasminogen Activator

Placebo

Clinical Study ID

NCT05491356
14724
  • Ages 18-100
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  1. Patients at increased risk of bleeding such as patients taking anticoagulationmedication that required reversal at time of intervention، or those withcoagulopathic disorder.

  2. Patients on antiplatelets or anticoagulation medications (DOACs or warfarin) withappropriate holding period prior to drainage, those who are eventually minimized toa regular bleeding risk compared to the normal population, will be included in thestudy.

  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 hrinterval scan.

  6. Patients who are not expected to live more than three months.

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Tissue Plasminogen Activator
Phase: 4
Study Start date:
May 11, 2023
Estimated Completion Date:
May 30, 2024

Study Description

A chronic subdural hematoma (CSDH) is a collection of blood overlying the brain that can be seen, usually in the elderly with even minimal head trauma. These are usually treated by removing the collection of blood. This can be done through a small drill hole in the skull or by larger holes (one or two) the size of a nickel. Sometimes a larger piece of skull is removed to be able to remove the CSDH. The standard practice at our center is to do these procedures under local anesthesia with a twist drill craniostomy (small drill hole through the skull). In some cases, all the CSDH can not be removed the first time, requiring a second procedure or a larger procedure. This study plans to use a type of medication that breaks down the solid blood clot, enabling more of it to drain. This medication (tpa) is already used in other surgeries and is safe to use in humans. Our preliminary experience and that of others suggests very low risk at the dosages being used. We hope that using this new drug will decrease the chance of the CSDH collecting again and reduce the overall length of your stay in the hospital and reduce the need for further surgery.

Connect with a study center

  • Hamilton General Hospital

    Hamilton, Ontario L8L 2X2
    Canada

    Site Not Available

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