Traumatic Intracranial HemorrhagePhase 3NCT05000060
Restart TICrH AP Pilot Trial
A Phase 3 study testing Timing/1 week and Timing/3 weeks in people with Traumatic Intracranial Hemorrhage, run by University of Texas at Austin.
Trial summary
A Prospective Randomized Open-Label Blinded Endpoint (PROBE) Pilot Trial of restarting antiplatelet therapy at 1 week versus 3 weeks after traumatic intracranial hemorrhage with a primary composite endpoint of major bleeding and vascular occlusive events. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Traumatic Intracranial Hemorrhage
- What is being tested?
- Timing/1 week and Timing/3 weeks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2022to 1 Oct 2023
- Phase
- Phase 3
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute traumatic intracranial hemorrhage on either mono or dual antiplatelet therapy
- History of stroke, vascular stent or coronary or peripheral arterial disease as indication for antiplatelet *Restarting dual platelet therapy requires one of the following indications: 1) Acute myocardial infarction in the last year; 2) Coronary stent in the last year; 3) Non-cardioembolic stroke in the last 21 days (with switch to monotherapy at 21 days post stroke) 4) Peripheral arterial stent in the past month (with switch to monotherapy at one month post stent placement).
Who cannot join
- SDH >8 mm maximum width or any midline shift at any time point or more than one SDH
- Physician plan to start/restart anticoagulant therapy during trial period
- Abbreviated Injury Scale other than head >3
- Pregnancy
- Inability to understand need for adherence to study protocol
- Any active pathological bleeding (no acute blood on most recent CT)
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- Hypersensitivity to drug or other label contraindication
- Any bleeding that the investigator deems unsafe to restart at 1 week post injury
- Inability to swallow
Trial locations and contacts
No sites are listed yet.
Ashkan J Shoamanesh, MD PhD contact
About this study
Official title: A Prospective Randomized Open-Label Blinded Endpoint (PROBE) Pilot Trial of Early Restarting Antiplatelet Therapy Versus Usual Care After Traumatic Intracranial Hemorrhage.
A Prospective Randomized Open-Label Blinded Endpoint (PROBE) Pilot Trial of restarting antiplatelet therapy at 1 week versus 3 weeks after traumatic intracranial hemorrhage with a primary composite endpoint of major bleeding and vascular occlusive events.
- Conditions
- Traumatic Intracranial Hemorrhage
- Being tested
- Timing/1 week, Timing/3 weeks
- Keywords
- restart, antiplatelet, traumatic intracranial hemorrhage
- Medical subject headings
- Intracranial Hemorrhage, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Timing/1 weekOther
Time of restart of antiplatelet therapy is one week after injury
Timing/3 weeksOther
Time of restart of antiplatelet therapy is left to treating clinician discretion
| Study group | Role | What they receive |
|---|---|---|
| 1 week restart | Experimental | Restart of mono or dual antiplatelet therapy one week post injury in TICrH patients Receives: Other: Timing/1 week |
| 3 week restart | Active comparator | Usual Care for restart of mono or dual antiplatelet therapy after TICrH at clinician's discretion Receives: Other: Timing/3 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
major bleeding
Recurrent ICrH or other major bleeding defined by BARC3A
Measured: 60 days
Major Vascular Occlusive events
Ischemic stroke; myocardial infarction; mesenteric ischemia; peripheral arterial occlusion; deep vein thrombosis; pulmonary embolism; and carotid, coronary, or peripheral arterial revascularization procedures. Major vascular events defined by the Antithrombotic Trialists' Collaboration
Measured: Baseline (gambles performed pre-randomization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start1 Oct 2022 (estimated)
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Intracranial HemorrhageStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective Randomized Open Label Blinded Endpoint pilot trial of 100 patients
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Truman J Milling Jr, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05000060
- Sponsor's protocol ID
- UT 101
- Status last verified
- Sep 2021
- First submitted
- 26 Jul 2021
- Last updated
- 7 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data sharing with NIH BIOLINCC
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Open-Label Blinded Endpoint (PROBE) Pilot Trial of Early Restarting Antiplatelet Therapy Versus Usual Care After Traumatic Intracranial Hemorrhage.
- ClinicalTrials.gov ID
- NCT05000060
- Acronym / sponsor ID
- UT 101
- Conditions
- Traumatic Intracranial Hemorrhage
- Keywords
- restart, antiplatelet, traumatic intracranial hemorrhage
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 11 Aug 2021 (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.
A Prospective Randomized Open-Label Blinded Endpoint (PROBE) Pilot Trial of restarting antiplatelet therapy at 1 week versus 3 weeks after traumatic intracranial hemorrhage with a primary composite endpoint of major bleeding and vascular occlusive events.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective Randomized Open Label Blinded Endpoint pilot trial of 100 patients
| Arm | Type | Receives |
|---|---|---|
| 1 week restart | Experimental | Other: Timing/1 weekRestart of mono or dual antiplatelet therapy one week post injury in TICrH patients |
| 3 week restart | Active comparator | Other: Timing/3 weeksUsual Care for restart of mono or dual antiplatelet therapy after TICrH at clinician's discretion |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Acute traumatic intracranial hemorrhage on either mono or dual antiplatelet therapy
- History of stroke, vascular stent or coronary or peripheral arterial disease as indication for antiplatelet *Restarting dual platelet therapy requires one of the following indications: 1) Acute myocardial infarction in the last year; 2) Coronary stent in the last year; 3) Non-cardioembolic stroke in the last 21 days (with switch to monotherapy at 21 days post stroke) 4) Peripheral arterial stent in the past month (with switch to monotherapy at one month post stent placement).
Key exclusion criteria (9 listed)
- SDH >8 mm maximum width or any midline shift at any time point or more than one SDH
- Physician plan to start/restart anticoagulant therapy during trial period
- Abbreviated Injury Scale other than head >3
- Pregnancy
- Inability to understand need for adherence to study protocol
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 |
|---|---|---|
| Timing/1 weekTime of restart of antiplatelet therapy is one week after injury | Other | 1 week restart |
| Timing/3 weeksTime of restart of antiplatelet therapy is left to treating clinician discretion | Other | 3 week restart |
Primary outcome
major bleeding
Time frame: 60 days
Recurrent ICrH or other major bleeding defined by BARC3A
Major Vascular Occlusive events
Time frame: Baseline (gambles performed pre-randomization)
Ischemic stroke; myocardial infarction; mesenteric ischemia; peripheral arterial occlusion; deep vein thrombosis; pulmonary embolism; and carotid, coronary, or peripheral arterial revascularization procedures. Major vascular events defined by the Antithrombotic Trialists' Collaboration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2021.
- Individual participant dataSharing planned: Yes. Data sharing with NIH BIOLINCC
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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.
Ashkan J Shoamanesh, MD PhD contact
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Timing/1 week and Timing/3 weeks in people with Traumatic Intracranial Hemorrhage, run by University of Texas at Austin.
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 2 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 7 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Truman J Milling, MD (15124969742, tjmilling@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
major bleeding (time frame: 60 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Oct 2021.