California Prehospital and In Hospital Antifibrinolytic Therapy Via TXA

Trauma Injury Clinical Trial

— Cal-PAT  

Official title:

Tranexamic Acid in Prehospital and In Hospital Civilian Trauma Care in Antifibrinolytic Therapy Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03469947
• Other study ID #: 2018-001
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: March 2015
• Est. completion date: December 2019

Study information

• Verified date: January 2019
• Source: Arrowhead Regional Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: December 2019
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhagic Shock
• Shock, Hemorrhagic
• Trauma Injury

Intervention

Drug:
• Tranexamic Acid
1 gram of prehospital Tranexamic Acid

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Arrowhead Regional Medical Center

References & Publications (3)

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. — View 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. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival at 24 hours	Mortality at 24 hours	24 hours
Primary	Survival at 48 hours	Mortality at 48 hours	48 hours
Primary	Survival at 28 days	Mortality at 28 days	28 days
Secondary	Blood Transfusion	Units of blood products needed (<2 units, 2-4 units, >4 units)	24 hours
Secondary	Length of Hospital Stay	Duration of ICU stay	28 days
Secondary	Adverse Events	Incidence of known adverse events associated with TXA	28 days