Clinical trial NCT03469947: California Prehospital and In Hospital Antifibrinolytic Therapy Via TXA
Official title: Tranexamic Acid in Prehospital and In Hospital Civilian Trauma Care in Antifibrinolytic Therapy Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hemorrhagic Shock
Trauma Injury
Keywords: Tranexamic Acid
TXA
Lead sponsor: Arrowhead Regional Medical Center
Sponsor class: OTHER
First posted: 2018-03-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective observational cohort administered TXA prehospital and a retrospective cohort for matched controls.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Blunt or penetrating trauma with signs and symptoms of hemorrhagic shock
* Systolic blood pressure less than 90 mmHg at scene of injury, during air and/or ground medical transport, or on arrival to designated trauma centers
* Any sustained blunt or penetrating injury within 3 hours
* Patient who are considered to be at high risk for significant hemorrhage

  1. Estimated blood loss of 500 milliliters int he field accompanied with HR \>120
  2. Bleeding not controlled by direct pressure or tourniquet
  3. Major amputation of any extremity above the wrists and above the ankles

Exclusion Criteria:

* Any patient under 18 years of age
* Any patient with an active thromboembolic event (within the last 24 hours) i.e. active stroke, myocardial infarction, or pulmonary embolism
* Any patient with a hypersensitivity or anaphylactic reaction to TXA
* Any patient more than 3 hours post injury
* 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
* Documented cervical cord injury with motor deficit

Primary outcomes:
measure: Survival at 24 hours
timeFrame: 24 hours
measure: Survival at 48 hours
timeFrame: 48 hours
measure: Survival at 28 days
timeFrame: 28 days
Secondary outcomes:
measure: Blood Transfusion
timeFrame: 24 hours
measure: Length of Hospital Stay
timeFrame: 28 days
measure: Adverse Events
timeFrame: 28 days
Other outcomes:
Locations:
Study officials:
affiliation: Arrowhead Regional Medical Center
name: Michael Neeki
role: PRINCIPAL_INVESTIGATOR
References:
citation: CRASH-2 collaborators; Roberts I, Shakur H, Afolabi A, Brohi K, Coats T, Dewan Y, Gando S, Guyatt G, Hunt BJ, Morales C, Perel P, Prieto-Merino D, Woolley T. The importance of early treatment with tranexamic acid in bleeding trauma patients: an exploratory analysis of the CRASH-2 randomised controlled trial. Lancet. 2011 Mar 26;377(9771):1096-101, 1101.e1-2. doi: 10.1016/S0140-6736(11)60278-X.
citation: Morrison JJ, Dubose JJ, Rasmussen TE, Midwinter MJ. Military Application of Tranexamic Acid in Trauma Emergency Resuscitation (MATTERs) Study. Arch Surg. 2012 Feb;147(2):113-9. doi: 10.1001/archsurg.2011.287. Epub 2011 Oct 17.
citation: Neeki MM, Dong F, Toy J, Vaezazizi R, Powell J, Jabourian N, Jabourian A, Wong D, Vara R, Seiler K, Pennington TW, Powell J, Yoshida-McMath C, Kissel S, Schulz-Costello K, Mistry J, Surrusco MS, O'Bosky KR, Van Stralen D, Ludi D, Sporer K, Benson P, Kwong E, Pitts R, Culhane JT, Borger R. Efficacy and Safety of Tranexamic Acid in Prehospital Traumatic Hemorrhagic Shock: Outcomes of the Cal-PAT Study. West J Emerg Med. 2017 Jun;18(4):673-683. doi: 10.5811/westjem.2017.2.32044. Epub 2017 Apr 19.