CAlcium and VAsopressin Following Injury Early Resuscitation (CAVALIER) Trial
RecruitingPhase 2
Who can join
Ages 18 to 90 · All sexes
Full 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
About the study
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.
What is being tested
- Calcium Gluconate (drug)
- Vasopressin (drug)
- saline placebo (drug)
Sponsor: Jason Sperry · Participants: 1,050 · Started: Jun 30, 2024
Contact the study team
- Jason Sperry, MD · Phone: 4128028270
Official record on ClinicalTrials.gov — NCT05958342
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.