CAlcium and VAsopressin Following Injury Early Resuscitation (CAVALIER) Trial

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Trauma, Hemorrhage

In brief

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.

Key facts

Study ID

NCT05958342

Run by

Jason Sperry

People needed

1050

Starts

2024-06-30

Expected to finish

2028-03-01

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• 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
• Anticipated admission to intensive care unit (ICU)

You may not qualify if…

• Prehospital Phase
• Wearing NO CAVALIER opt-out bracelet
• Age > 90 or < 18 years of age
• Isolated fall from standing injury mechanism
• Known prisoner
• Known pregnancy
• Traumatic arrest with > 5 minutes of CPR without return of vital signs
• Brain matter exposed or penetrating brain injury
• Isolated drowning or hanging victims
• Objection to study voiced by subject or family member at the scene or at the trauma center
• Inability to obtain IV/IO access
• Early In-Hospital Phase:
• Wearing NO CAVALIER opt-out bracelet
• Age > 90 or < 18 years of age
• Isolated fall from standing injury mechanism
• Known prisoner
• Known pregnancy
• Traumatic arrest with > 5 minutes of CPR without return of vital signs
• Brain matter exposed or penetrating brain injury
• Isolated drowning or hanging victims
• Objection to study voiced by subject or family member at the scene or at the trauma center
• Inability to obtain IV access

Where it is running

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

Full record on ClinicalTrials.gov

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