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NCT Number: NCT05491356

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

tissue plasminogen activator

Drug

Dosage of 1mg/mL mixed in 0.9% saline solution, intra-catheter administration, sterile

Placebo

Drug

0.9% saline solution, intra-catheter administration, sterile

Primary outcomes

  1. Study Feasibility

    Time frame: 8 months

    Patient recruitment rate, eligibility of patients, protocol adherence, unexpected events

Secondary outcomes

  1. Reoperation rate

    Time frame: 8 months

    Reoperation rate or reintervention in the first 6 weeks post drainage

  2. Volume of chronic subdural hematoma

    Time frame: 8 months

    Volume, as measured in 3 intervals: pre-procedure, post-procedure at 24hrs and 6 weeks

  3. Rate of adverse events

    Time frame: 8 months

    Rate of adverse events in the first 6 weeks post procedure, including CNS infection, seizure, post-op hemorrhage

  4. Length of hospital stay

    Time frame: 8 months

    length of hospital stay in days

Sponsors and collaborators

Lead sponsor

Hamilton Health Sciences Corporation

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 8, 2022
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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