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CAlcium and VAsopressin Following Injury Early Resuscitation (CAVALIER) Trial

RecruitingPhase 2Ages 18 Years - 90 YearsAllJason Sperry
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • Calcium Gluconate
  • Vasopressin
  • saline placebo
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Where

18 sites
Chandler Regional Medical Center
Chandler, United States
University of Arizona
Tucson, United States
University of Arkansas for Medical Sciences
Little Rock, United States
Zuckerberg San Francisco General Hospital and Trauma Center at University of California, San Francisco
San Francisco, United States
University of Colorado Anschutz Medical Campus
Aurora, United States
Denver Health Medical Center
Denver, United States
University of Miami
Miami, United States
University of Maryland, Baltimore
Baltimore, United States

…and 10 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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