Platelet Transfusion and Repeat TEG-PM in Patients With Severe TBI on Antiplatelet Therapy (Repea… (NCT06433622) | Clinical Trial Compass
By InvitationNot Applicable
Platelet Transfusion and Repeat TEG-PM in Patients With Severe TBI on Antiplatelet Therapy (Repeat TEG-PM)
United States225 participantsStarted 2023-12-01
Plain-language summary
The aim of this study is to see if administering platelets (cells in our blood that stop or prevent bleeding) results in improved platelet function and slows/stops the progression of a head bleed for patients who have a traumatic head bleed and are on antiplatelet therapy (medications that stop blood cells from forming a blood clot) prior to admission.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria for Interventional Portion of Study:
* Patients ≥ 18 years of age who present with TICH meeting Brain Injury Guidelines (BIG) 2 or 3 head bleed criteria
* Currently on antiplatelet medication on admission
* Must have taken this antiplatelet medication within the past 48 hours prior to presentation
* Patients who have AA and/or ADP inhibition of 70% or greater and Maximum Amplitude (MA) \<50 will then receive a platelet transfusion and a repeat TEG-PM 1hr after transfusion
Exclusion Criteria for Interventional Portion of Study:
* Under 18 years of age
* Have a known bleeding diatheses
* Current therapeutic anticoagulation use
* Do not know the time of their last antiplatelet medication dose
* Patients or their proxy who are unable to provide consent
* Patients with concomitant long bone fractures or solid organ injuries
Inclusion Criteria for Retrospective Portion of Study:
• Patients with a TICH who are 18 years of age or older
Exclusion Criteria for Retrospective Portion of Study:
* Abbreviated Injury Scale (AIS) \>1 in body regions other than head because of concomitant long bone fracture or solid organ injury
* Under 18 years of age
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Repeat TEG
Timeframe: 1 hour after platelets given
2
Repeat Head CT
Timeframe: From the time of interventional platelet administration until the time of patient discharge from their index admission, assessed up to 100 weeks.