Antithrombin for Traumatic Injury-related Blood Clots

(TRAIT Trial)

Recruiting at 3 trial locations

Overseen By Jeanette M Podbielski

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Bryan Cotton

Must not be taking: Anticoagulants, Unfractionated heparin

Disqualifiers: Pregnancy, Burns, Head injuries, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

314 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine if additional interventions will assist with decreasing the risk and/or severity of thromboembolism (clotting complications) in patients who have experienced a major traumatic event.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those who are already using anticoagulants (blood thinners) before hospital admission.

What data supports the effectiveness of the drug Thrombate infusion for traumatic injury-related blood clots?

Research shows that Thrombate infusions, which contain antithrombin, are safe and effective in patients with thermal injuries (burns), helping to increase antithrombin levels in the blood. This suggests that Thrombate might also help manage blood clot issues in trauma patients. ^{1 2 3 4 5}

Is antithrombin safe for use in humans?

A study on antithrombin in trauma patients suggests that decreased antithrombin activity is linked to fluid leakage from blood vessels, but not due to its consumption, indicating a need for further research on its safety and effects. ^{2 4 6 7 8}

How is Thrombate infusion different from other treatments for traumatic injury-related blood clots?

Thrombate infusion, which involves antithrombin (a protein that helps prevent blood clots), is unique because it can be used without heparin (a common blood thinner), potentially reducing the risk of bleeding complications. This treatment is administered intravenously (through a vein) and has shown effectiveness in conditions like disseminated intravascular coagulation, making it a novel option for managing blood clots related to traumatic injuries. ^{1 2 9 10 11}

Research Team

Bryan A Cotton, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

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.

Inclusion Criteria

Informed consent obtained

I have multiple severe injuries or a major bone fracture.

I have been admitted to the trauma ICU or Surgical Intermediate Care Unit.

Exclusion Criteria

I have been using blood thinners before being hospitalized.

I have a blood or immune system disorder.

Known allergy to Antithrombin or its components

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Thrombate infusion or placebo to assess the impact on thromboembolism risk

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Placebo
• Thrombate infusion

Trial Overview 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.

Participant Groups

Group I: Thrombate infusion Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Bryan Cotton

Lead Sponsor

Trials

1

Recruited

1,600+

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Grifols Shared Services North America, Ind.

Collaborator

Trials

1

Recruited

310+

Grifols Therapeutics LLC

Industry Sponsor

Trials

59

Recruited

6,000+

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of Antithrombin III Administration on the Prognosis of Severe Trauma Patients with Disseminated Intravascular Coagulation. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Decreased antithrombin activity in the early phase of trauma is strongly associated with extravascular leakage, but not with antithrombin consumption: a prospective observational study. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Antithrombin(H) concentrate infusions are safe and effective in patients with thermal injuries. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Early venous thromboembolism prophylaxis with enoxaparin in patients with blunt traumatic brain injury. [2016]

5. India pubmed.ncbi.nlm.nih.gov

Clinical Characteristics, Management Practices, and In-hospital Outcomes among Trauma Patients with Venous Thromboembolism. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Association of timing of initiation of pharmacologic venous thromboembolism prophylaxis with outcomes in trauma patients. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

A comparison of low-dose heparin with low-molecular-weight heparin as prophylaxis against venous thromboembolism after major trauma. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Antifactor Xa levels in four patients with burn injuries who received enoxaparin to prevent venous thromboembolism. [2004]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Antithrombin (human) concentrate infusion in pediatric patients with >50% TBSA burns. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Recombinant human antithrombin inhibits thrombin formation and interleukin 6 release in human endotoxemia. [2015]

11. United States pubmed.ncbi.nlm.nih.gov

High dose of intravenous antithrombin III without heparin in the treatment of disseminated intravascular coagulation and organ failure in four children. [2004]