RECRUITING Phase 2 ClinicalTrials.gov

CAlcium and VAsopressin Following Injury Early Resuscitation (CAVALIER) Trial

Sponsor: Jason Sperry • ClinicalTrials.gov ID: NCT05958342

Registry updated: 2026-09-29

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Description

The CAlcium and VAsopressin following Injury Early Resuscitation (CAVALIER) Trial is a proposed 4 year, double-blind, mutli-center, prehospital and early in hospital phase randomized trial designed to determine the efficacy and safety of prehospital calcium and early in hospital vasopressin in patients at risk of hemorrhagic shock.

Interventions

Calcium Gluconate (Drug)
1 gram calcium gluconate provided via intravenous or intraosseous access over approximately 2-5 minutes
Vasopressin (Drug)
4 unit vasopressin bolus followed by vasopressin infusion at 0.04 U/min for eight hours
saline placebo (Drug)
saline placebo volume matched to prehospital or in hospital phase

Eligibility criteria

Inclusion Criteria: Prehospital Phase: Injured patients at risk of hemorrhagic shock being transported from scene or referral hospital to a participating CAVALIER trial site who meet the following criteria: 1A. Systolic blood pressure ≤ 90mmHg and tachycardia (HR ≥ 108) at scene, at outside hospital, or during anticipated transport to a participating CAVALIER trial site OR 1B. Systolic blood pressure ≤ 70mmHg at scene, at outside hospital, or during anticipated transport to a participating CAVALIER trial site Early In-Hospital Phase: Injured patients at a participating CAVALIER trial site at risk of hemorrhagic shock who meet the following criteria: 1A. Systolic blood pressure ≤ 90mmHg and tachycardia (HR ≥ 108) at scene, at outside hospital, during transport, or in emergency department of a participating CAVALIER trial site OR 1B. Systolic blood pressure ≤ 70mmHg at scene, at outside hospital, during transport, or in emergency department of a participating CAVALIER trial site AND 2.Blood/blood component transfusion initiated in prehospital setting or deemed clinically indicated within 60 minutes of arrival at the enrolling trauma center AND 3. Clinical team deems Operating Room for major hemorrhage control procedure (e.g., laparotomy, thoracotomy, vascular exploration or extremity amputation) indicated within 60 minutes of arrival at the enrolling trauma center AND 4\. Anticipated admission to intensive care unit (ICU) Exclusion Criteria: Prehospital Phase 1. Wearing NO CAVALIER opt-out bracelet 2. Age \> 90 or \< 18 years of age 3. Isolated fall from standing injury mechanism 4. Known prisoner 5. Known pregnancy 6. Traumatic arrest with \> 5 minutes of CPR without return of vital signs 7. Brain matter exposed or penetrating brain injury 8. Isolated drowning or hanging victims 9. Objection to study voiced by subject or family member at the scene or at the trauma center 10. Inability to obtain IV/IO access Early In-Hospital Phase: 1. Wearing NO CAVALIER opt-out bracelet 2. Age \> 90 or \< 18 years of age 3. Isolated fall from standing injury mechanism 4. Known prisoner 5. Known pregnancy 6. Traumatic arrest with \> 5 minutes of CPR without return of vital signs 7. Brain matter exposed or penetrating brain injury 8. Isolated drowning or hanging victims 9. Objection to study voiced by subject or family member at the scene or at the trauma center 10. Inability to obtain IV access

Conditions

Trauma Hemorrhage

Locations

Chandler Regional Medical Center — Chandler, Arizona, United States
University of Arizona — Tucson, Arizona, United States
University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
Zuckerberg San Francisco General Hospital and Trauma Center at University of California, San Francisco — San Francisco, California, United States
University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States
Denver Health Medical Center — Denver, Colorado, United States
University of Miami — Miami, Florida, United States
University of Maryland, Baltimore — Baltimore, Maryland, United States
Hennepin County Medical Center — Minneapolis, Minnesota, United States
University of Mississippi Medical Center — Jackson, Mississippi, United States
University of Missouri Health Care — Columbia, Missouri, United States
University of New Mexico — Albuquerque, New Mexico, United States
The Ohio State University Wexner Medical Center — Columbus, Ohio, United States
Mount Carmel East Hospital — Columbus, Ohio, United States
Allegheny Health Network — Pittsburgh, Pennsylvania, United States
University of Pittsburgh — Pittsburgh, Pennsylvania, United States
Texas Tech University Health Sciences Center — Lubbock, Texas, United States
University of Washington Harborview Medical Center — Seattle, Washington, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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