A Phase 4 interventional study of Tissue Plasminogen Activator and Placebo in Hematoma, Subdural and Fibrinolytic; Hemorrhage, sponsored by Hamilton Health Sciences Corporation. Completed at 1 site in Canada. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-03-12.
Sponsored by Hamilton Health Sciences Corporation · Phase 4, Interventional, and Treatment
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.
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.
44 studies on the registry are indexed under Hematoma, Subdural; 15 are open to participants now.
This study's enrollment of 40 is below the median of 105 across 30 interventional studies indexed under Hematoma, Subdural.
Browse Hematoma, Subdural studies →Hamilton Health Sciences Corporation is the lead sponsor of 242 studies on the registry; 38 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
This group will receive 2mL of intra-catheter tPA during twist drill craniostomy procedure
Drug: Tissue Plasminogen Activator
This group will receive 2mL of intra-catheter saline solution during twist drill craniostomy procedure
Drug: Placebo
Dosage of 1mg/mL mixed in 0.9% saline solution, intra-catheter administration, sterile
0.9% saline solution, intra-catheter administration, sterile
Study Feasibility
Patient recruitment rate, eligibility of patients, protocol adherence, unexpected events
Time frame: 8 months
Reoperation rate
Reoperation rate or reintervention in the first 6 weeks post drainage
Time frame: 8 months
Volume of chronic subdural hematoma
Volume, as measured in 3 intervals: pre-procedure, post-procedure at 24hrs and 6 weeks
Time frame: 8 months
Rate of adverse events
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
length of hospital stay in days
Time frame: 8 months
Plan to share: Undecided — 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.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Tissue Plasminogen Activator
Hamilton Health Sciences Corporation →