Traumatic Hemorrhage Clinical Trial
— STAAMPOfficial title:
Study of Tranexamic Acid During Air and Ground Medical Prehospital Transport Trial For Trauma Patients At Risk Of Hemorrhage (STAAMP Trial); Phase III Multicenter, Prospective, Randomized, Double Blind, Interventional Trial
Verified date | September 2020 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine if 1 gram of prehospital tranexamic acid given during emergency medical transport to a level 1 trauma center in patients at risk of hemorrhage is associated with lower 30 day mortality.
Status | Completed |
Enrollment | 903 |
Est. completion date | November 2019 |
Est. primary completion date | November 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria: 1. Blunt or penetrating injured patients at risk of bleeding being transported via air or ground medical services from the scene of injury or from referring hospital to a definitive trauma center that is participating in the trial AND 2. Within 2 hours of time of injury AND 3. Hypotension (Systolic Blood Pressure (SBP) < 90mmHg) - At scene of injury or during air or ground medical transport - Documented at referring hospital prior to air or ground medical transport arrival OR 4. Tachycardia (heart rate >110 beats per minute) - At scene of injury or during air or ground medical transport - Documented at referring hospital prior to air or ground medical transport arrival Exclusion Criteria: 1. Age > 90 or < 18 years of age 2. Inability to obtain intravenous access or intraosseous 3. Documented (radiographic evidence) cervical cord injury with motor deficit 4. Known prisoner 5. Known pregnancy 6. Traumatic arrest with > 5 minutes CPR without return of vital signs 7. Penetrating cranial injury 8. Traumatic brain injury with brain matter exposed 9. Isolated drowning or hanging victims 10. Wearing an opt out bracelet. 11. Isolated fall from standing 12. Patient or Family Objection at scene |
Country | Name | City | State |
---|---|---|---|
United States | University of Pittsburgh | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Jason Sperry | The University of Texas at San Antonio, University of Arizona, University of Utah |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 30 Day Mortality | Because not all patients had available data regarding 30-day mortality (patients were discharged and there 30-day outcome was unable to be determined) there may be differences between the 30Day mortality relative to the other outcomes. There were 5 and 4 patients from each arm that did not have 30-day outcome and thus are different. | 30 Day | |
Secondary | 24 Hour Mortality | 24 Hours | ||
Secondary | Acute Lung Injury | 7 days | ||
Secondary | Multiple Organ Failure | 30 days | ||
Secondary | Nosocomial Infection | 30 days | ||
Secondary | 24 Hour Total Blood Transfusion | 24 hours | ||
Secondary | Hyperfinbrinolysis | 24 hours |
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