Antithrombin for Traumatic Injury-related Blood Clots

(TRAIT Trial)

Enrolling by invitation 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether Thrombate, an antithrombin infusion, can reduce blood clot risk in individuals with major traumatic injuries, such as multiple broken bones. Participants will receive either Thrombate or a placebo to determine if the treatment prevents clotting complications after a serious accident. It targets those admitted to a trauma unit with significant injuries. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Thrombate infusions, containing the protein antithrombin, are safe and effective for patients with burns. These infusions increase antithrombin levels, which can be low in injured individuals. The FDA has already approved Thrombate for other uses, such as preventing blood clots in certain conditions, indicating it is generally well-tolerated. Studies reviewed report no major side effects, suggesting that Thrombate appears to be a safe option for those with traumatic injuries. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for traumatic injury-related blood clots, which often involve anticoagulants like heparin or warfarin, Thrombate infusion is unique because it specifically targets and replenishes antithrombin, a protein that helps regulate blood clotting. This new approach can be particularly beneficial for patients who may have reduced levels of antithrombin due to their injuries. Researchers are excited because Thrombate infusion not only offers a targeted mechanism of action but also has the potential to stabilize clot formation more effectively, reducing the risk of complications associated with standard anticoagulants.

What evidence suggests that Thrombate infusion might be an effective treatment for blood clots related to traumatic injury?

Research shows that Thrombate infusions, containing the protein antithrombin, effectively reduce blood clots in patients with severe burns. Antithrombin prevents abnormal clotting in blood vessels. Studies have shown that patients with insufficient antithrombin often suffer more severe injuries and increased bleeding. Clinical studies also indicate that Thrombate reliably treats clotting problems. In this trial, some participants will receive Thrombate infusions to evaluate their effectiveness in reducing the risk of dangerous blood clots in patients who have experienced major trauma. ^{1 2 3 6 7}

Who Is on the Research Team?

Bryan A Cotton, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11327888/

Antithrombin III Levels and Outcomes Among Patients With ... In this cohort study of patients with trauma, antithrombin III deficiency was associated with greater injury severity, increased hemorrhage, and ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39145978/

Antithrombin III Levels and Outcomes Among Patients With ... In this cohort study of patients with trauma, antithrombin III deficiency was associated with greater injury severity, increased hemorrhage, and increased ...

3. withpower.com withpower.com/trial/phase-2-wounds-and-injuries-3-2023-3ef6a

Antithrombin 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 ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05794165

Study Details | NCT05794165 | Antithrombin to Improve ... The purpose of this study is to determine if additional interventions will assist with decreasing the risk and/or severity of thromboembolism (clotting ...

5. thrombate.com thrombate.com/en/thrombate-iii

THROMBATE III (antithrombin III [human]) | Official HCP Site Clinical studies have shown that THROMBATE III is an effective choice for patients with hATd and for the treatment and prevention of thromboembolism, ...

6. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/2793540

Association of Changes in Antithrombin Activity Over Time ... Recent data show that 20% to 70% of trauma patients have acquired antithrombin deficiency on admission, defined as antithrombin activity below ...

7. researchgate.net researchgate.net/publication/383154630_Antithrombin_III_Levels_and_Outcomes_Among_Patients_With_Trauma

Antithrombin III Levels and Outcomes Among Patients With ... Conclusions and Relevance In this cohort study of patients with trauma, antithrombin III deficiency was associated with greater injury severity, increased ...