Phase 2
N=150
Tranexamic Acid Mechanisms and Pharmacokinetics in Traumatic Injury
Hemorrhage · Shock · Wounds and Injuries
Bottom Line
View on ClinicalTrials.gov: NCT02535949 ↗Enrolled (actual)
150
Serious AEs
30.2%
Results posted
Aug 2021
Primary outcome: Primary: Change in HLA-DR Expression on Monocytes 72 Hours After Drug or Placebo Administration in Patient Groups (0g TXA (Placebo); 2g TXA; 4g TXA)." — 0.503; 0.509; 0.532 fold change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Tranexamic Acid (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Jul 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in HLA-DR Expression on Monocytes 72 Hours After Drug or Placebo Administration in Patient Groups (0g TXA (Placebo); 2g TXA; 4g TXA)." |
0.503; 0.509; 0.532 | — |
| SECONDARY Differences in Cytokine Profiles Between the Three Study Groups |
34.24; 32.75; 29.34; 25.67; 21.69; 21.58 | — |
| SECONDARY Differences in Leukocyte Function Parameters Between the Three Study Groups |
0.875; 0.967; 0.844; 0.917; 0.870; 0.817 | — |
| SECONDARY Total Transfusion Volume CL |
0.03 | — |
| SECONDARY Determine the Incidence of Thromboembolic Events (DVT, MI, PE, Stroke) in All Three Study Groups. |
13; 16; 6 | — |
| SECONDARY Determine the Incidence of Seizures at 24 Hours in All Three Study Groups. |
0; 1; 0 | — |
| SECONDARY Determine the Incidence of All Adverse Events in All Three Study Groups |
168; 264; 138 | — |
| SECONDARY Platelet Count CL |
0.45 | — |
| SECONDARY Near Infrared Spectroscopy CL |
-0.27 | — |
| SECONDARY Creatinine Count CL |
-0.084 | — |
| SECONDARY V2- Peripheral Volume (L/70kg) |
1080 | — |
| SECONDARY Q- Intercompartmental Clearance (L/70kg) |
174 | — |
| SECONDARY V1- Central Volume (L/70kg) |
1160 | — |
| SECONDARY CL- Clearance of TXA (mL/(Min*70kg)) |
109 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Patients with traumatic injury that are ordered to receive at least 1 blood product and/or
- Patients admitted to the Emergency Department with a traumatic injury and require immediate transfer to the operating room to control the bleeding
- 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
- Patients known to be < 18 years of age
- Suspected Acute MI or stroke(thromboembolic and/or hemorrhagic) on admission
- Known inherited coagulation disorders
- 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
- Known history of seizures and/or seizure after injury/on admission related to this hospitalization
- Suspected or known pregnancy
- Known to be lactating
- Suspected or known prisoners
- Futile care
- Known current state of immunosuppression (i.e. on high dose steroids, chemotherapeutics, etc.)
- 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
Data sourced from ClinicalTrials.gov (NCT02535949). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.