Study of Tranexamic Acid During Air and Ground Medical Prehospital Transport Trial (STAAMP Trial)
STAAMP
1 other identifier
interventional
903
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2015
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 6, 2014
CompletedFirst Posted
Study publicly available on registry
March 13, 2014
CompletedStudy Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2019
CompletedResults Posted
Study results publicly available
September 10, 2020
CompletedSeptember 10, 2020
September 1, 2020
4.3 years
March 6, 2014
July 11, 2020
September 9, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
24 Hour Mortality
24 Hours
Acute Lung Injury
7 days
Multiple Organ Failure
30 days
Nosocomial Infection
30 days
24 Hour Total Blood Transfusion
24 hours
- +1 more secondary outcomes
Study Arms (2)
Prehospital Tranexamic Acid
EXPERIMENTAL1 gram of Tranexamic Acid will be given during emergency medical transport
Control
PLACEBO COMPARATORIdentical volume of saline during emergency medical transport
Interventions
Eligibility Criteria
You may qualify if:
- 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
- Within 2 hours of time of injury AND
- 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
- 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
You may not qualify if:
- Age \> 90 or \< 18 years of age
- Inability to obtain intravenous access or intraosseous
- Documented (radiographic evidence) cervical cord injury with motor deficit
- Known prisoner
- Known pregnancy
- Traumatic arrest with \> 5 minutes CPR without return of vital signs
- Penetrating cranial injury
- Traumatic brain injury with brain matter exposed
- Isolated drowning or hanging victims
- Wearing an opt out bracelet.
- Isolated fall from standing
- Patient or Family Objection at scene
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jason Sperrylead
- University of Arizonacollaborator
- The University of Texas at San Antoniocollaborator
- University of Utahcollaborator
Study Sites (1)
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Related Publications (3)
Lorence JM, Donohue JK, Iyanna N, Guyette FX, Gimbel E, Brown JB, Daley BJ, Eastridge BJ, Miller RS, Nirula R, Harbrecht BG, Claridge JA, Phelan HA, Vercruysse G, O'Keeffe T, Joseph B, Neal MD, Sperry JL. Characterization of adverse events in injured patients at risk of hemorrhagic shock: a secondary analysis of three harmonized prehospital randomized clinical trials. Trauma Surg Acute Care Open. 2024 Jun 25;9(1):e001465. doi: 10.1136/tsaco-2024-001465. eCollection 2024.
PMID: 38933603DERIVEDGruen DS, Brown JB, Guyette FX, Johansson PI, Stensballe J, Li SR, Leeper CM, Eastridge BJ, Nirula R, Vercruysse GA, O'Keeffe T, Joseph B, Neal MD, Sperry JL. Prehospital tranexamic acid is associated with a dose-dependent decrease in syndecan-1 after trauma: A secondary analysis of a prospective randomized trial. J Trauma Acute Care Surg. 2023 Nov 1;95(5):642-648. doi: 10.1097/TA.0000000000003955. Epub 2023 May 1.
PMID: 37125811DERIVEDGuyette FX, Brown JB, Zenati MS, Early-Young BJ, Adams PW, Eastridge BJ, Nirula R, Vercruysse GA, O'Keeffe T, Joseph B, Alarcon LH, Callaway CW, Zuckerbraun BS, Neal MD, Forsythe RM, Rosengart MR, Billiar TR, Yealy DM, Peitzman AB, Sperry JL; STAAMP Study Group. Tranexamic Acid During Prehospital Transport in Patients at Risk for Hemorrhage After Injury: A Double-blind, Placebo-Controlled, Randomized Clinical Trial. JAMA Surg. 2020 Oct 5;156(1):11-20. doi: 10.1001/jamasurg.2020.4350. Online ahead of print.
PMID: 33016996DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Jason Sperry MD, MPH
- Organization
- University of Pittsburgh
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD, MPH
Study Record Dates
First Submitted
March 6, 2014
First Posted
March 13, 2014
Study Start
July 1, 2015
Primary Completion
November 1, 2019
Study Completion
November 1, 2019
Last Updated
September 10, 2020
Results First Posted
September 10, 2020
Record last verified: 2020-09