A Phase 3 interventional study of Tranexamic Acid in Hemorrhagic Shock and Trauma Injury, sponsored by Arrowhead Regional Medical Center. Completed. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-07-30.
Sponsored by Arrowhead Regional Medical Center · Phase 3, Interventional, and Treatment
The California Prehospital Antifibrinolytic Therapy (Cal-PAT) study seeks to evaluate the safety and efficacy of Tranexamic Acid (TXA) use in the civilian prehospital and in hospital setting in cases of traumatic hemorrhagic shock.
The Cal-PAT study is a multi-centered, prospective, observational cohort study. From March 2015 to July 2017, patients ≥ 18-years-old who sustained blunt or penetrating trauma with signs of hemorrhagic shock identified were considered for TXA treatment by first responders in the prehospital setting and physicians in hospital. A control group was formed of patients seen in the five years prior to data collection cessation (June 2012 to July 2017) at each receiving center who were not administered TXA. Control group patients were selected through propensity score matching based on gender, age, injury severity scores, and mechanism of injury. The primary outcome measured was mortality. Secondary outcomes measured included the total blood products transfused, the hospital and intensive care unit length of stay, and the incidence of known adverse events associated with TXA.
81 studies on the registry are indexed under Shock, Hemorrhagic; 16 are open to participants now.
This study's enrollment of 200 is above the median of 100 across 42 interventional studies indexed under Shock, Hemorrhagic.
Browse Shock, Hemorrhagic studies →Arrowhead Regional Medical Center is the lead sponsor of 15 studies on the registry; 2 are open to participants now.
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Patient who are considered to be at high risk for significant hemorrhage
Exclusion Criteria:
1 gram of Tranexamic Acid will be given during medical transport
Drug: Tranexamic Acid
Retrospective matched controls
1 gram of prehospital Tranexamic Acid
Survival at 24 hours
Mortality at 24 hours
Time frame: 24 hours
Survival at 48 hours
Mortality at 48 hours
Time frame: 48 hours
Survival at 28 days
Mortality at 28 days
Time frame: 28 days
Blood Transfusion
Units of blood products needed (\<2 units, 2-4 units, \>4 units)
Time frame: 24 hours
Length of Hospital Stay
Duration of ICU stay
Time frame: 28 days
Adverse Events
Incidence of known adverse events associated with TXA
Time frame: 28 days
No study locations are listed for this record.
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Plan to share: No
Ran from Mar 2015 to primary completion in Jul 2024, 112 months.
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This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tranexamic Acid
Arrowhead Regional Medical Center