Hematoma, SubduralPhase 4NCT05491356
Use of Tissue Plasminogen Activator in the Clearance of Chronic Subdural Hematomas
A Phase 4 study testing Tissue Plasminogen Activator in people with Hematoma, Subdural and Fibrinolytic; Hemorrhage, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Hematoma, Subdural, Fibrinolytic; Hemorrhage
- What is being tested?
- Tissue Plasminogen Activator
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 11 May 2023to 30 May 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (18 yrs or older)
- Admitted to neurosurgery wing at the hospital
- Symptomatic patients requiring surgical drainage by twist drill craniostomy
Who cannot join
- Patients at increased risk of bleeding such as patients taking anticoagulation medication that required reversal at time of intervention، or those with coagulopathic disorder.
- 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.
- Patients with subdural empyema.
- Redo twist drill craniostomy for residual cSDH within the same admission.
- Drain accidentally removed during nursing care or patient transport before 24 hr interval scan.
- Patients who are not expected to live more than three months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Utility of Intra-Catheter Fibrinolytics in Draining Chronic Subdural Hematomas: A Randomized Controlled Trial Pilot Study
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.
Read the 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
- Being tested
- Tissue Plasminogen Activator, Placebo
- Medical subject headings
- Hematoma, Subdural, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue Plasminogen ActivatorDrug
Dosage of 1mg/mL mixed in 0.9% saline solution, intra-catheter administration, sterile
PlaceboDrug
0.9% saline solution, intra-catheter administration, sterile
| Study group | Role | What they receive |
|---|---|---|
| Intervention - tPA administered | Experimental | This group will receive 2mL of intra-catheter tPA during twist drill craniostomy procedure Receives: Drug: Tissue Plasminogen Activator |
| Placebo Control | Placebo comparator | This group will receive 2mL of intra-catheter saline solution during twist drill craniostomy procedure Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study Feasibility
Patient recruitment rate, eligibility of patients, protocol adherence, unexpected events
Measured: 8 months
Secondary outcomes (4)
Reoperation rate
Reoperation rate or reintervention in the first 6 weeks post drainage
Measured: 8 months
Volume of chronic subdural hematoma
Volume, as measured in 3 intervals: pre-procedure, post-procedure at 24hrs and 6 weeks
Measured: 8 months
Rate of adverse events
Rate of adverse events in the first 6 weeks post procedure, including CNS infection, seizure, post-op hemorrhage
Measured: 8 months
Length of hospital stay
length of hospital stay in days
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start11 May 2023
- Primary completion30 Mar 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hematoma, SubduralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Kesava Reddy, Principal investigator, Hamilton Health Sciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05491356
- Sponsor's protocol ID
- 14724
- Status last verified
- Mar 2024
- First submitted
- 4 Aug 2022
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Neils DM, Singanallur PS, Wang H, Tracy P, Klopfenstein J, Dinh D, Elwood PW, Fassett D, McCall T, Lin J, Tsung A. Recurrence-free chronic subdural hematomas: a retrospective analysis of the instillation of tissue plasminogen activator in addition to twist drill or burr hole drainage in the treatment of chronic subdural hematomas. World Neurosurg. 2012 Jul;78(1-2):145-9. doi: 10.1016/j.wneu.2011.08.032. Epub 2011 Nov 7.
PubMed 22120294Brazdzionis J, Patchana T, Wiginton JG 4th, Wacker MR, Menoni R, Miulli DE. Intracatheter Tissue Plasminogen Activator for Chronic Subdural Hematomas after Failed Bedside Twist Drill Craniostomy: A Retrospective Review. Cureus. 2019 Dec 26;11(12):e6472. doi: 10.7759/cureus.6472.
PubMed 32025399O YM, Tsang SL, Leung GK. Fibrinolytic-Facilitated Chronic Subdural Hematoma Drainage-A Systematic Review. World Neurosurg. 2021 Jun;150:e408-e419. doi: 10.1016/j.wneu.2021.03.029. Epub 2021 Mar 17.
PubMed 33722722
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility of Intra-Catheter Fibrinolytics in Draining Chronic Subdural Hematomas: A Randomized Controlled Trial Pilot Study
- ClinicalTrials.gov ID
- NCT05491356
- Acronym / sponsor ID
- 14724
- Conditions
- Hematoma, Subdural, Fibrinolytic; Hemorrhage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Study start
- 11 May 2023 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 8 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention - tPA administered | Experimental | Drug: Tissue Plasminogen ActivatorThis group will receive 2mL of intra-catheter tPA during twist drill craniostomy procedure |
| Placebo Control | Placebo comparator | Drug: PlaceboThis group will receive 2mL of intra-catheter saline solution during twist drill craniostomy procedure |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients (18 yrs or older)
- Admitted to neurosurgery wing at the hospital
- Symptomatic patients requiring surgical drainage by twist drill craniostomy
Key exclusion criteria (6 listed)
- Patients at increased risk of bleeding such as patients taking anticoagulation medication that required reversal at time of intervention، or those with coagulopathic disorder.
- 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.
- Patients with subdural empyema.
- Redo twist drill craniostomy for residual cSDH within the same admission.
- Drain accidentally removed during nursing care or patient transport before 24 hr interval scan.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tissue Plasminogen ActivatorDosage of 1mg/mL mixed in 0.9% saline solution, intra-catheter administration, sterile | Drug | Intervention - tPA administered |
| Placebo0.9% saline solution, intra-catheter administration, sterile | Drug | Placebo Control |
Primary outcome
Study Feasibility
Time frame: 8 months
Patient recruitment rate, eligibility of patients, protocol adherence, unexpected events
4 secondary outcomes
Reoperation rate
Time frame: 8 months
Volume of chronic subdural hematoma
Time frame: 8 months
Rate of adverse events
Time frame: 8 months
Length of hospital stay
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Background: PubMed 22120294Neils DM, Singanallur PS, Wang H, Tracy P, Klopfenstein J, Dinh D, Elwood PW, Fassett D, McCall T, Lin J, Tsung A. Recurrence-free chronic subdural hematomas: a retrospective analysis of the instillation of tissue plasminogen activator in addition to twist drill or burr hole drainage in the treatment of chronic subdural hematomas. World Neurosurg. 2012 Jul;78(1-2):145-9. doi: 10.1016/j.wneu.2011.08.032. Epub 2011 Nov 7.
- Background: PubMed 32025399Brazdzionis J, Patchana T, Wiginton JG 4th, Wacker MR, Menoni R, Miulli DE. Intracatheter Tissue Plasminogen Activator for Chronic Subdural Hematomas after Failed Bedside Twist Drill Craniostomy: A Retrospective Review. Cureus. 2019 Dec 26;11(12):e6472. doi: 10.7759/cureus.6472.
- Background: PubMed 33722722O YM, Tsang SL, Leung GK. Fibrinolytic-Facilitated Chronic Subdural Hematoma Drainage-A Systematic Review. World Neurosurg. 2021 Jun;150:e408-e419. doi: 10.1016/j.wneu.2021.03.029. Epub 2021 Mar 17.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Kesava Reddy principal investigator
Hamilton Health Sciences Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tissue Plasminogen Activator in people with Hematoma, Subdural and Fibrinolytic; Hemorrhage, run by Hamilton Health Sciences Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study Feasibility (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05491356, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.