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Anticoagulant

Antithrombin for Traumatic Injury-related Blood Clots (TRAIT Trial)

Phase 2
Waitlist Available
Led By Bryan A Cotton, MD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Polytraumatic injuries OR pelvic/long bone fracture
Admission to trauma ICU or Surgical Intermediate Care Unit (SIMU)
Must not have
Known prehospital anticoagulant use
Known hematologic or immunologic disorders
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years

Summary

This trial will study if extra treatments can help reduce the risk and/or seriousness of blood clots after a major injury. #health

Who is the study for?
This trial is for patients in the trauma ICU or SIMU after a major injury, like multiple traumas or fractures. They must consent to participate and not be pregnant, have blood/immune disorders, take prehospital anticoagulants, have allergies to Antithrombin, be in another study without approval, be prisoners directly admitted from jail, have severe burns (>20% TBSA), or non-survivable head injuries.
What is being tested?
The study is testing if Thrombate (an antithrombin infusion) can reduce clotting issues better than a placebo in people who've had serious injuries. Participants will randomly receive either Thrombate or a placebo as part of their care.
What are the potential side effects?
Thrombate may cause allergic reactions, bleeding problems due to reduced clot formation ability and potential interactions with other drugs that affect blood clotting.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have multiple severe injuries or a major bone fracture.
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I have been admitted to the trauma ICU or Surgical Intermediate Care Unit.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been using blood thinners before being hospitalized.
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I have a blood or immune system disorder.
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Over 20% of my body has been burned.
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I was first treated with a specific blood thinner for clot prevention.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Thrombate infusionExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
957 Previous Clinical Trials
347,808 Total Patients Enrolled
Grifols Shared Services North America, Ind.UNKNOWN
Grifols Therapeutics LLCIndustry Sponsor
58 Previous Clinical Trials
5,794 Total Patients Enrolled
Bryan A Cotton, MDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
1 Previous Clinical Trials
1,604 Total Patients Enrolled

Media Library

Thrombate infusion (Anticoagulant) Clinical Trial Eligibility Overview. Trial Name: NCT05794165 — Phase 2
Blood Clot Research Study Groups: Thrombate infusion, Placebo
Blood Clot Clinical Trial 2023: Thrombate infusion Highlights & Side Effects. Trial Name: NCT05794165 — Phase 2
Thrombate infusion (Anticoagulant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05794165 — Phase 2
~187 spots leftby Nov 2026
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