NCT05491356

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Hamilton Health Sciences Corporation · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Hematoma, Subdural
• Fibrinolytic; Hemorrhage

Interventions

Type	Name	Description
DRUG	Tissue Plasminogen Activator	Dosage of 1mg/mL mixed in 0.9% saline solution, intra-catheter administration, sterile
DRUG	Placebo	0.9% saline solution, intra-catheter administration, sterile

Timeline

• Start date: 2023-05-11
• Primary completion: 2024-03-30
• Completion: 2024-05-30
• First posted: 2022-08-08
• Last updated: 2026-03-12

Locations

1 site across 1 country: Canada