Traumatic HemorrhagePhase 3STAAMPNCT02086500
Study of Tranexamic Acid During Air and Ground Medical Prehospital Transport Trial (STAAMP Trial)
A Phase 3 study testing Tranexamic Acid in people with Traumatic Hemorrhage, run by Jason Sperry at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Traumatic Hemorrhage
- What is being tested?
- Tranexamic Acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 903 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Nov 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- OR
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official 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
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.
Read the detailed description
Background: Traumatically injured patients continue to be plagued with uncontrolled hemorrhage resulting in significant morbidity and early mortality. A primary driving force for this unbridled hemorrhage is known to be the early coagulopathy which complicates severe injury. Trauma induced coagulopathy has been postulated to be an equilibrium imbalance between pro and anticoagulant factors, platelets, endothelium and fibrinolysis soon after injury. Recent evidence demonstrates that the early use of the antifibrinolytic agent tranexamic acid (TXA) after trauma center arrival results in improved survival in patients at risk for bleeding. Bringing this proven treatment to the prehospital arena and intervening earlier in those patients who would otherwise not be candidates for treatment has the real potential to further reduce or prevent the vicious hemorrhagic cascade, improve clinical outcomes and provide insight into the underlying mechanisms responsible for and which maximize its benefit.
Objective/Hypothesis: The primary hypothesis will be that prehospital infusion of tranexamic acid in patients at risk for bleeding will reduce the incidence of 30 day mortality. The secondary hypotheses include that prehospital tranexamic acid will reduce the incidence of hyperfibrinolysis, acute lung injury, multiple organ failure, nosocomial infection, mortality, early seizures, pulmonary embolism and early resuscitation needs, reduce or prevent the early coagulopathy as demonstrated by improving presenting INR and rapid thromboelastography parameters, reduce the early inflammatory response, plasmin levels, leukocyte, platelet and complement activation, and determine the optimal dosing of tranexamic acid post-injury.
- Conditions
- Traumatic Hemorrhage
- Being tested
- Tranexamic Acid, Saline control
- Keywords
- Tranexamic acid, randomized, hemorrhage, blinded
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
1 gram of prehospital Tranexamic Acid
Saline controlOther
Saline Control
| Study group | Role | What they receive |
|---|---|---|
| Prehospital Tranexamic Acid | Experimental | 1 gram of Tranexamic Acid will be given during emergency medical transport Receives: Drug: Tranexamic Acid |
| Control | Placebo comparator | Identical volume of saline during emergency medical transport Receives: Other: Saline control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 Day
Secondary outcomes (6)
24 Hour Mortality
Measured: 24 Hours
Acute Lung Injury
Measured: 7 days
Multiple Organ Failure
Measured: 30 days
Nosocomial Infection
Measured: 30 days
24 Hour Total Blood Transfusion
Measured: 24 hours
Hyperfinbrinolysis
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2014 (estimated)
- Study startJul 2015
- Primary completionNov 2019
- Study completionNov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Traumatic HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 903 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jason Sperry
- Sponsor type
- University, hospital or other
- Collaborators
- University of Arizona, The University of Texas at San Antonio, University of Utah
- Responsible party
- Sponsor-investigator, Jason Sperry, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02086500
- Sponsor's protocol ID
- W81XWH1320080 IND 121102
- Acronym
- STAAMP
- Status last verified
- Sep 2020
- First submitted
- 6 Mar 2014
- Last updated
- 10 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 38933603Gruen 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.
PubMed 37125811Guyette 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.
PubMed 33016996
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02086500
- Acronym / sponsor ID
- STAAMP / W81XWH1320080 IND 121102
- Conditions
- Traumatic Hemorrhage
- Keywords
- Tranexamic acid, randomized, hemorrhage, blinded
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 903 participants (actual)
- Lead sponsor
- Jason SperryUniversity, hospital or other
- Collaborators
- University of Arizona, The University of Texas at San Antonio, University of Utah
- Study start
- Jul 2015 (actual)
- Primary completion
- Nov 2019 (actual)
- Study completion
- Nov 2019 (actual)
- First posted
- 13 Mar 2014 (estimated)
- Results
- Posted 10 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background: Traumatically injured patients continue to be plagued with uncontrolled hemorrhage resulting in significant morbidity and early mortality. A primary driving force for this unbridled hemorrhage is known to be the early coagulopathy which complicates severe injury. Trauma induced coagulopathy has been postulated to be an equilibrium imbalance between pro and anticoagulant factors, platelets, endothelium and fibrinolysis soon after injury. Recent evidence demonstrates that the early use of the antifibrinolytic agent tranexamic acid (TXA) after trauma center arrival results in improved survival in patients at risk for bleeding. Bringing this proven treatment to the prehospital arena and intervening earlier in those patients who would otherwise not be candidates for treatment has the real potential to further reduce or prevent the vicious hemorrhagic cascade, improve clinical outcomes and provide insight into the underlying mechanisms responsible for and which maximize its benefit.
Objective/Hypothesis: The primary hypothesis will be that prehospital infusion of tranexamic acid in patients at risk for bleeding will reduce the incidence of 30 day mortality. The secondary hypotheses include that prehospital tranexamic acid will reduce the incidence of hyperfibrinolysis, acute lung injury, multiple organ failure, nosocomial infection, mortality, early seizures, pulmonary embolism and early resuscitation needs, reduce or prevent the early coagulopathy as demonstrated by improving presenting INR and rapid thromboelastography parameters, reduce the early inflammatory response, plasmin levels, leukocyte, platelet and complement activation, and determine the optimal dosing of tranexamic acid post-injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prehospital Tranexamic Acid | Experimental | Drug: Tranexamic Acid1 gram of Tranexamic Acid will be given during emergency medical transport |
| Control | Placebo comparator | Other: Saline controlIdentical volume of saline during emergency medical transport |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
- OR
- Tachycardia (heart rate >110 beats per minute)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic Acid1 gram of prehospital Tranexamic Acid | Drug | Prehospital Tranexamic Acid |
| Saline controlSaline Control | Other | Control |
Primary outcome
30 Day Mortality
Time frame: 30 Day
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.
6 secondary outcomes
24 Hour Mortality
Time frame: 24 Hours
Acute Lung Injury
Time frame: 7 days
Multiple Organ Failure
Time frame: 30 days
Nosocomial Infection
Time frame: 30 days
24 Hour Total Blood Transfusion
Time frame: 24 hours
Hyperfinbrinolysis
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38933603Lorence 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.
- Derived from this study: PubMed 37125811Gruen 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.
- Derived from this study: PubMed 33016996Guyette 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tranexamic Acid in people with Traumatic Hemorrhage, run by Jason Sperry at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30 Day Mortality (time frame: 30 Day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02086500, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2020.