Clot-Busting drug may help clear brain bleeds during surgery
NCT ID NCT05491356
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether giving a clot-busting drug called tPA directly into a chronic subdural hematoma (a slow brain bleed) helps drain it better during surgery. Forty adults who needed a twist-drill drainage procedure took part. The main goal was to see if the approach is feasible and safe, not yet to prove it works better than standard care.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tissue plasminogen activator (tPA)
- What this could lead to
- If it works, this could lead to a better way to clear blood clots from the brain, possibly reducing the need for repeat surgeries.
- What could go wrong
- This is a small pilot study with only 40 people, so results may not apply widely. tPA also carries a risk of bleeding, especially in patients on blood thinners.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
40 people
The number who actually took part.
- Started
-
May 2023
- Finished
-
May 2024
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 100 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2, Canada
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