Hamilton General Hospital
Hamilton, Ontario, L8L 2X2, Canada
NCT Number: NCT05491356
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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Notify Me18 year–100 year
All sexes
Interventional
Phase 4
Hamilton, Ontario, L8L 2X2, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Dosage of 1mg/mL mixed in 0.9% saline solution, intra-catheter administration, sterile
0.9% saline solution, intra-catheter administration, sterile
Time frame: 8 months
Patient recruitment rate, eligibility of patients, protocol adherence, unexpected events
Time frame: 8 months
Reoperation rate or reintervention in the first 6 weeks post drainage
Time frame: 8 months
Volume, as measured in 3 intervals: pre-procedure, post-procedure at 24hrs and 6 weeks
Time frame: 8 months
Rate of adverse events in the first 6 weeks post procedure, including CNS infection, seizure, post-op hemorrhage
Time frame: 8 months
length of hospital stay in days
Hamilton Health Sciences Corporation
Other
The Utility of Intra-Catheter Fibrinolytics in Draining Chronic Subdural Hematomas: A Randomized Controlled Trial Pilot Study
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