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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prehospital Tranexamic Acid | Experimental | 1 gram of Tranexamic Acid will be given during medical transport |
|
| Matched Controls | No Intervention | Retrospective matched controls |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid | Drug | 1 gram of prehospital Tranexamic Acid |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Transfusion | Units of blood products needed (<2 units, 2-4 units, >4 units) | 24 hours |
| Length of Hospital Stay | Duration of ICU stay |
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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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Neeki | Arrowhead Regional Medical Center | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21439633 | Background | 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. | |
| 22006852 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 7, 2018 | Mar 16, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012771 | Shock, Hemorrhagic |
| D000081084 | Accidental Injuries |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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Prospective observational cohort administered TXA prehospital and a retrospective cohort for matched controls.
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| 28 days |
| Adverse Events | Incidence of known adverse events associated with TXA | 28 days |
| 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. |
| 28611888 | Result | 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. |
| D014947 |
| Wounds and Injuries |