Tranexamic Acid Mechanisms and Pharmacokinetics in Traumatic Injury

• Status: Completed
• Trial end date: 2017-07-07
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effects of TXA on the immune system, its pharmacokinetics, as well as safety and efficacy in severely injured trauma patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Collaborator: United States Department of Defense
• Treatments: Tranexamic Acid

Criteria

Inclusion Criteria:

1. Patients with traumatic injury that are ordered to receive at least 1 blood product and/or

2. Patients admitted to the Emergency Department with a traumatic injury and require immediate transfer to the operating room to control the bleeding

3. Able to receive the study drug within 2 hours from estimated time of injury **Please note that in circumstances where the patient initially met inclusion/exclusion criteria (i.e. received blood products in the ED before a full evaluation of their injuries is complete) but is later found to only have a soft tissue involved injury or does not have a traumatic bleeding source), the Investigator may determine that the patient should not be randomized into the trial and the patient should be considered a screen failure

Exclusion Criteria:

1. Patients known to be < 18 years of age

2. Suspected Acute MI or stroke(thromboembolic and/or hemorrhagic) on admission

3. Known inherited coagulation disorders

4. Known history of thromboembolic events (DVT, PE, MI, Stroke)

• Please note that past medical history of hemorrhagic stroke is permitted, but not current admission with hemorrhagic stroke

5. Known history of seizures and/or seizure after injury/on admission related to this hospitalization

6. Suspected or known pregnancy

7. Known to be lactating

8. Suspected or known prisoners

9. Futile care

10. Known current state of immunosuppression (i.e. on high dose steroids, chemotherapeutics, etc.)

11. Unknown estimated time of injury 12). Patients wearing an "Opt Out" TAMPITI Study bracelet 13). Known presence of subarachnoid hemorrhage.

14.) Isolated injuries to hands and/or feet (distal) 15.) Administration of antifibrinolytics pre-hospital and/or during this ED admission prior to enrollment