Back to results

California Prehospital and In Hospital Antifibrinolytic Therapy Via TXA (Cal-PAT)

Primary Purpose

Hemorrhagic Shock, Trauma Injury

Status

Unknown status

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Tranexamic Acid

About this trial

This is an interventional treatment trial for Hemorrhagic Shock focused on measuring Tranexamic Acid, TXA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Prehospital Tranexamic Acid

Matched Controls

Arm Description

1 gram of Tranexamic Acid will be given during medical transport

Retrospective matched controls

Outcomes

Primary Outcome Measures

Survival at 24 hours

Mortality at 24 hours

Survival at 48 hours

Mortality at 48 hours

Survival at 28 days

Mortality at 28 days

Secondary Outcome Measures

Blood Transfusion

Units of blood products needed (<2 units, 2-4 units, >4 units)

Length of Hospital Stay

Duration of ICU stay

Adverse Events

Incidence of known adverse events associated with TXA

Full Information

NCT ID

NCT03469947

First Posted

March 8, 2018

Last Updated

January 8, 2019

Sponsor

Arrowhead Regional Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03469947

Brief Title

California Prehospital and In Hospital Antifibrinolytic Therapy Via TXA

Acronym

Cal-PAT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Unknown status

Study Start Date

March 2015 (Actual)

Primary Completion Date

July 2018 (Actual)

Study Completion Date

December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Arrowhead Regional Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hemorrhagic Shock, Trauma Injury

Keywords

Tranexamic Acid, TXA

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Prehospital Tranexamic Acid

Arm Type

Experimental

Arm Description

1 gram of Tranexamic Acid will be given during medical transport

Arm Title

Matched Controls

Arm Type

No Intervention

Arm Description

Retrospective matched controls

Intervention Type

Drug

Intervention Name(s)

Tranexamic Acid

Intervention Description

1 gram of prehospital Tranexamic Acid

Primary Outcome Measure Information:

Title

Survival at 24 hours

Description

Mortality at 24 hours

Time Frame

24 hours

Title

Survival at 48 hours

Description

Mortality at 48 hours

Time Frame

48 hours

Title

Survival at 28 days

Description

Mortality at 28 days

Time Frame

28 days

Secondary Outcome Measure Information:

Title

Blood Transfusion

Description

Units of blood products needed (<2 units, 2-4 units, >4 units)

Time Frame

24 hours

Title

Length of Hospital Stay

Description

Duration of ICU stay

Time Frame

28 days

Title

Adverse Events

Description

Incidence of known adverse events associated with TXA

Time Frame

28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Neeki

Organizational Affiliation

Arrowhead Regional Medical Center

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

21439633

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.

Results Reference

background

PubMed Identifier

22006852

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.

Results Reference

background

PubMed Identifier

28611888

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.

Results Reference

result

Learn more about this trial

California Prehospital and In Hospital Antifibrinolytic Therapy Via TXA

We'll reach out to this number within 24 hrs