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Study of Tranexamic Acid During Air and Ground Medical Prehospital Transport Trial (STAAMP Trial) (STAAMP)

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ClinicalTrials.gov Identifier: NCT02086500
Recruitment Status : Completed
First Posted : March 13, 2014
Results First Posted : September 10, 2020
Last Update Posted : September 10, 2020
Sponsor:
Collaborators:
University of Arizona
The University of Texas at San Antonio
University of Utah
Information provided by (Responsible Party):
Jason Sperry, University of Pittsburgh

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Traumatic Hemorrhage
Interventions Drug: Tranexamic Acid
Other: Saline control
Enrollment 903
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Prehospital Tranexamic Acid Control
Hide Arm/Group Description

1 gram of Tranexamic Acid will be given during emergency medical transport

Tranexamic Acid: 1 gram of prehospital Tranexamic Acid

Identical volume of saline during emergency medical transport

Saline control: Saline Control

Period Title: Overall Study
Started 447 456
Completed 447 456
Not Completed 0 0
Arm/Group Title Prehospital Tranexamic Acid Control Total
Hide Arm/Group Description

1 gram of Tranexamic Acid will be given during emergency medical transport

Tranexamic Acid: 1 gram of prehospital Tranexamic Acid

Identical volume of saline during emergency medical transport

Saline control: Saline Control

Total of all reporting groups
Overall Number of Baseline Participants 447 456 903
Hide Baseline Analysis Population Description
of the 927 patients enrolled in the prehospital environment, 903 were able to be analyzed
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 447 participants 456 participants 903 participants
39
(26 to 53)
39
(26 to 56)
39
(26 to 54)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 447 participants 456 participants 903 participants
Female
120
  26.8%
115
  25.2%
235
  26.0%
Male
327
  73.2%
341
  74.8%
668
  74.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 447 participants 456 participants 903 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
   0.4%
3
   0.7%
5
   0.6%
Native Hawaiian or Other Pacific Islander
2
   0.4%
3
   0.7%
5
   0.6%
Black or African American
49
  11.0%
40
   8.8%
89
   9.9%
White
353
  79.0%
361
  79.2%
714
  79.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
41
   9.2%
49
  10.7%
90
  10.0%
1.Primary Outcome
Title 30 Day Mortality
Hide Description 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.
Time Frame 30 Day
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Prehospital Tranexamic Acid Control
Hide Arm/Group Description:

1 gram of Tranexamic Acid will be given during emergency medical transport

Tranexamic Acid: 1 gram of prehospital Tranexamic Acid

Identical volume of saline during emergency medical transport

Saline control: Saline Control

Overall Number of Participants Analyzed 442 452
Measure Type: Count of Participants
Unit of Measure: Participants
36
   8.1%
45
  10.0%
2.Secondary Outcome
Title 24 Hour Mortality
Hide Description [Not Specified]
Time Frame 24 Hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prehospital Tranexamic Acid Control
Hide Arm/Group Description:

1 gram of Tranexamic Acid will be given during emergency medical transport

Tranexamic Acid: 1 gram of prehospital Tranexamic Acid

Identical volume of saline during emergency medical transport

Saline control: Saline Control

Overall Number of Participants Analyzed 447 453
Measure Type: Count of Participants
Unit of Measure: Participants
16
   3.6%
17
   3.8%
3.Secondary Outcome
Title Acute Lung Injury
Hide Description [Not Specified]
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prehospital Tranexamic Acid Control
Hide Arm/Group Description:

1 gram of Tranexamic Acid will be given during emergency medical transport

Tranexamic Acid: 1 gram of prehospital Tranexamic Acid

Identical volume of saline during emergency medical transport

Saline control: Saline Control

Overall Number of Participants Analyzed 447 453
Measure Type: Count of Participants
Unit of Measure: Participants
42
   9.4%
39
   8.6%
4.Secondary Outcome
Title Multiple Organ Failure
Hide Description [Not Specified]
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prehospital Tranexamic Acid Control
Hide Arm/Group Description:

1 gram of Tranexamic Acid will be given during emergency medical transport

Tranexamic Acid: 1 gram of prehospital Tranexamic Acid

Identical volume of saline during emergency medical transport

Saline control: Saline Control

Overall Number of Participants Analyzed 447 453
Measure Type: Count of Participants
Unit of Measure: Participants
33
   7.4%
39
   8.6%
5.Secondary Outcome
Title Nosocomial Infection
Hide Description [Not Specified]
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prehospital Tranexamic Acid Control
Hide Arm/Group Description:

1 gram of Tranexamic Acid will be given during emergency medical transport

Tranexamic Acid: 1 gram of prehospital Tranexamic Acid

Identical volume of saline during emergency medical transport

Saline control: Saline Control

Overall Number of Participants Analyzed 447 453
Measure Type: Count of Participants
Unit of Measure: Participants
88
  19.7%
66
  14.6%
6.Secondary Outcome
Title 24 Hour Total Blood Transfusion
Hide Description [Not Specified]
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prehospital Tranexamic Acid Control
Hide Arm/Group Description:

1 gram of Tranexamic Acid will be given during emergency medical transport

Tranexamic Acid: 1 gram of prehospital Tranexamic Acid

Identical volume of saline during emergency medical transport

Saline control: Saline Control

Overall Number of Participants Analyzed 447 453
Median (Inter-Quartile Range)
Unit of Measure: units of blood transfusion
0
(0 to 2)
0
(0 to 2)
7.Secondary Outcome
Title Hyperfinbrinolysis
Hide Description [Not Specified]
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prehospital Tranexamic Acid Control
Hide Arm/Group Description:

1 gram of Tranexamic Acid will be given during emergency medical transport

Tranexamic Acid: 1 gram of prehospital Tranexamic Acid

Identical volume of saline during emergency medical transport

Saline control: Saline Control

Overall Number of Participants Analyzed 447 453
Measure Type: Count of Participants
Unit of Measure: Participants
145
  32.4%
144
  31.8%
Time Frame Hospital Admission to 30 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Prehospital Tranexamic Acid Control
Hide Arm/Group Description

1 gram of Tranexamic Acid will be given during emergency medical transport

Tranexamic Acid: 1 gram of prehospital Tranexamic Acid

Identical volume of saline during emergency medical transport

Saline control: Saline Control

All-Cause Mortality
Prehospital Tranexamic Acid Control
Affected / at Risk (%) Affected / at Risk (%)
Total   36/447 (8.05%)      45/456 (9.87%)    
Hide Serious Adverse Events
Prehospital Tranexamic Acid Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/447 (0.89%)      7/456 (1.54%)    
Blood and lymphatic system disorders     
Arterial Thromboembolic event NOS   2/447 (0.45%)  2 2/456 (0.44%)  2
Cardiac disorders     
MI   0/447 (0.00%)  0 1/456 (0.22%)  1
Nervous system disorders     
Stroke  [1]  1/447 (0.22%)  1 2/456 (0.44%)  2
Seizure   1/447 (0.22%)  1 1/456 (0.22%)  1
Respiratory, thoracic and mediastinal disorders     
Pulmonary Embolus   0/447 (0.00%)  0 1/456 (0.22%)  1
Indicates events were collected by systematic assessment
[1]
Stroke
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Prehospital Tranexamic Acid Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/447 (0.89%)      14/456 (3.07%)    
Blood and lymphatic system disorders     
Venous Thromboembolic Event NOS   0/447 (0.00%)  0 1/456 (0.22%)  1
Gastrointestinal disorders     
ileus   1/447 (0.22%)  1 1/456 (0.22%)  1
Nausea   0/447 (0.00%)  0 1/456 (0.22%)  1
Metabolism and nutrition disorders     
Metabolic Acidosis   1/447 (0.22%)  1 0/456 (0.00%)  0
Hypertriglyceridemia   0/447 (0.00%)  0 1/456 (0.22%)  1
Nervous system disorders     
Hydrocephalus   0/447 (0.00%)  0 1/456 (0.22%)  1
Seizure   0/447 (0.00%)  0 2/456 (0.44%)  2
Stroke   0/447 (0.00%)  0 2/456 (0.44%)  2
Respiratory, thoracic and mediastinal disorders     
Pulmonary Embolus   1/447 (0.22%)  1 0/456 (0.00%)  0
Pnuemonitis   0/447 (0.00%)  0 1/456 (0.22%)  1
Respiratory Failure   0/447 (0.00%)  0 1/456 (0.22%)  1
Pneumothorax   1/447 (0.22%)  1 3/456 (0.66%)  3
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Jason Sperry MD, MPH
Organization: University of Pittsburgh
Phone: 4128028270
EMail: sperryjl@upmc.edu
Layout table for additonal information
Responsible Party: Jason Sperry, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02086500    
Other Study ID Numbers: W81XWH1320080 IND 121102
First Submitted: March 6, 2014
First Posted: March 13, 2014
Results First Submitted: July 11, 2020
Results First Posted: September 10, 2020
Last Update Posted: September 10, 2020