Tranexamic Acid
Drug1 gram of prehospital Tranexamic Acid
NCT Number: NCT03469947
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.
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Notify Me18 year–90 year
All sexes
Interventional
Phase 3
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
1 gram of prehospital Tranexamic Acid
Time frame: 24 hours
Mortality at 24 hours
Time frame: 48 hours
Mortality at 48 hours
Time frame: 28 days
Mortality at 28 days
Time frame: 24 hours
Units of blood products needed (<2 units, 2-4 units, >4 units)
Time frame: 28 days
Duration of ICU stay
Time frame: 28 days
Incidence of known adverse events associated with TXA
Arrowhead Regional Medical Center
Other
Tranexamic Acid in Prehospital and In Hospital Civilian Trauma Care in Antifibrinolytic Therapy Study
Acronym: Cal-PAT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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