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

March 26, 2024 updated by: Hamilton Health Sciences Corporation

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Dr. Kesava Reddy
  • Phone Number: 905-521-0061
  • Email: reddy@hhsc.ca

Study Contact Backup

  • Name: Jessy Moore, MSc
  • Phone Number: 289-686-8827
  • Email: moorej@hhsc.ca

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Recruiting
        • Hamilton General Hospital
        • Contact:
          • Dr. Kesava Reddy
          • Phone Number: 905-521-2100
          • Email: reddy@hhsc.ca
        • Contact:
        • Principal Investigator:
          • Dr. Kesava Reddy
        • Sub-Investigator:
          • Dr. Mohamed Alhantoobi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention - tPA administered
This group will receive 2mL of intra-catheter tPA during twist drill craniostomy procedure
Drug: Tissue Plasminogen Activator
Dosage of 1mg/mL mixed in 0.9% saline solution, intra-catheter administration, sterile
Placebo Comparator: Placebo Control
This group will receive 2mL of intra-catheter saline solution during twist drill craniostomy procedure
Drug: Placebo
0.9% saline solution, intra-catheter administration, sterile

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Study Feasibility
Time Frame: 8 months
Patient recruitment rate, eligibility of patients, protocol adherence, unexpected events
8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reoperation rate
Time Frame: 8 months
Reoperation rate in the first 6 weeks post drainage
8 months
Volume of chronic subdural hematoma
Time Frame: 8 months
Volume, as measured in 3 intervals: pre-procedure, post-procedure at 24hrs and 6 weeks
8 months
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
8 months
Length of hospital stay
Time Frame: 8 months
length of hospital stay in days
8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hamilton Health Sciences Corporation

Investigators

  • Principal Investigator: Dr. Kesava Reddy, Hamilton Health Sciences Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 11, 2023

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

July 30, 2024

Study Registration Dates

First Submitted

August 4, 2022

First Submitted That Met QC Criteria

August 4, 2022

First Posted (Actual)

August 8, 2022

Study Record Updates

Last Update Posted (Actual)

March 28, 2024

Last Update Submitted That Met QC Criteria

March 26, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14724

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Patient data will be de-identified and the data will be analyzed as a whole before becoming available to other researchers.

De-identified IPD may be shared with other researchers if necessary based on occurrence of adverse events occurrence, circumstantial findings, etc.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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