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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-11

Study Completion Date

2024-05-30

Brief Summary

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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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Detailed Description

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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

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Hematoma, Subdural Fibrinolytic; Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Intervention - tPA administered

This group will receive 2mL of intra-catheter tPA during twist drill craniostomy procedure

Group Type EXPERIMENTAL

Tissue Plasminogen Activator

Intervention Type DRUG

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

Placebo Control

This group will receive 2mL of intra-catheter saline solution during twist drill craniostomy procedure

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

0.9% saline solution, intra-catheter administration, sterile

Interventions

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Tissue Plasminogen Activator

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

Intervention Type DRUG

Placebo

0.9% saline solution, intra-catheter administration, sterile

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No