California Prehospital and In Hospital Antifibrinolytic Therapy Via TXA

NCT03469947 | Completed Phase 3 FDA Drug

• 1 other identifier: 2018-001
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hemorrhagic Shock; Trauma Injury

Keywords

Tranexamic Acid; TXA

Outcome Measures

Primary Outcomes (3)

• Survival at 24 hours

  Mortality at 24 hours

  24 hours

• Survival at 48 hours

  Mortality at 48 hours

  48 hours

• Survival at 28 days

  Mortality at 28 days

  28 days

Secondary Outcomes (3)

• Blood Transfusion

  24 hours

• Length of Hospital Stay

  28 days

• Adverse Events

  28 days

Study Arms (2)

Prehospital Tranexamic Acid

EXPERIMENTAL

1 gram of Tranexamic Acid will be given during medical transport

Drug: Tranexamic Acid

Matched Controls

NO INTERVENTION

Retrospective matched controls

Interventions

Tranexamic Acid DRUG

1 gram of prehospital Tranexamic Acid

Prehospital Tranexamic Acid

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Arrowhead Regional Medical Center: lead

Related 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.

  PMID: 21439633 BACKGROUND

• 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.

  PMID: 22006852 BACKGROUND

• 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.

  PMID: 28611888 RESULT

MeSH Terms

Conditions

Shock, Hemorrhagic; Accidental Injuries

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Michael Neeki

  Arrowhead Regional Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research - Emergency Medicine

Model Details: Prospective observational cohort administered TXA prehospital and a retrospective cohort for matched controls.

Study Record Dates

• First Submitted: March 8, 2018
• First Posted: March 19, 2018
• Study Start: March 1, 2015
• Primary Completion: July 29, 2024
• Study Completion: July 29, 2024
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share