Your session is about to expire
← Back to Search
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time of hospital admission, day1, day2, day 3, day 4, day 5, day6, day 7
Awards & highlights
TRAIT Trial 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.Check my eligibility
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.See study design
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.
TRAIT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have multiple severe injuries or a major bone fracture.
Select...
I have been admitted to the trauma ICU or Surgical Intermediate Care Unit.
TRAIT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time of hospital admission, day1, day2, day 3, day 4, day 5, day6, day 7
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time of hospital admission, day1, day2, day 3, day 4, day 5, day6, day 7
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with incidence of antifactor Xa (anti-FXa) of ≥0.2 IU/mL
Number of participants with incidences of venous thromboembolism (VTE )
Secondary outcome measures
Antithrombin (AT) activity level
Change in level of Inflammatory marker Interferon -gamma (INFg) as assessed by a blood test
Change in level of Inflammatory marker Interleukin-1 alpha (IL1a) as assessed by a blood test
+15 moreTRAIT 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
903 Previous Clinical Trials
320,663 Total Patients Enrolled
2 Trials studying Deep Vein Thrombosis
51 Patients Enrolled for Deep Vein Thrombosis
Grifols Shared Services North America, Ind.UNKNOWN
Grifols Therapeutics LLCIndustry Sponsor
57 Previous Clinical Trials
5,494 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been using blood thinners before being hospitalized.I have multiple severe injuries or a major bone fracture.I have been admitted to the trauma ICU or Surgical Intermediate Care Unit.I have a blood or immune system disorder.People who are currently in prison.Over 20% of my body has been burned.You have head injuries that are not survivable.I was first treated with a specific blood thinner for clot prevention.You have experienced a very serious injury or have been sent to the highest level trauma center for treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Thrombate infusion
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you explain the potential hazards of Thrombate infusion?
"Our team rated Thrombate infusion a 2 on the safety scale, as it is currently in Phase 2 of its trial and has some evidence backing up its safety but none for efficacy."
Answered by AI
Are there still opportunities to join this clinical trial?
"Based on the information hosted by clinicaltrials.gov, this trial is not presently enrolling patients; however, it was first posted in April 1st 2023 and last updated on March 28th of that same year. There are 844 other trials actively seeking participants at this current time."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger