Actively Recruiting
CAlcium and VAsopressin Following Injury Early Resuscitation (CAVALIER) Trial
Led by Jason Sperry · Updated on 2026-06-03
1050
Participants Needed
15
Research Sites
52 weeks
Total Duration
On this page
Sponsors
J
Jason Sperry
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
The CAlcium and VAsopressin following Injury Early Resuscitation (CAVALIER) Trial is a multi-center, double-blind, randomized study lasting four years. It focuses on patients at risk of hemorrhagic shock after traumatic injury, evaluating whether early administration of calcium and vasopressin can improve resuscitation outcomes. The trial aims to understand the safety and effectiveness of these treatments during the prehospital and early hospital phases of care. Participants may receive either 1 gram of calcium gluconate intravenously or intraosseously before arriving at the trauma bay, or a matching saline placebo. In the early hospital phase, patients may receive a vasopressin bolus followed by an infusion for eight hours, or a volume-matched saline placebo. These interventions are compared to standard care to assess their effects on hemorrhagic shock management. Throughout the study, participants will be monitored for mortality up to 30 days, blood transfusion needs, organ failure, infections, coagulation status, and time to hemostasis. Ionized calcium levels will be measured during early resuscitation. The trial also tracks intensive care unit and hospital-free days. Safety and treatment effects are assessed from enrollment through hospital stay and follow-up periods.
CONDITIONS
Brief Title
CAlcium and VAsopressin Following Injury Early Resuscitation (CAVALIER) Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Injured patients aged 18 to 90 years at risk of hemorrhagic shock being transported to or present at a participating trial site
- Systolic blood pressure ≤ 90 mmHg with heart rate ≥ 108 bpm or systolic blood pressure ≤ 70 mmHg at scene, outside hospital, during transport, or in emergency department
- Blood transfusion started or clinically indicated within 60 minutes of arrival at enrolling trauma center
- Operating room needed for major hemorrhage control within 60 minutes of trauma center arrival
- Anticipated admission to intensive care unit (ICU)
You will not qualify if you...
- Wearing a NO CAVALIER opt-out bracelet
- Age under 18 or over 90 years
- Injury from isolated fall from standing
- Known prisoner status
- Known pregnancy
- Traumatic arrest with more than 5 minutes of CPR without return of vital signs
- Brain matter exposed or penetrating brain injury
- Isolated drowning or hanging
- Objection to study by subject or family at scene or trauma center
- Inability to obtain intravenous or intraosseous access (prehospital phase requires IV/IO; in-hospital phase requires IV)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Screening and enrollment occur at the trauma center prior to intervention.
Duration - From injury scene until hospital arrival
Participants receive 1 gram calcium gluconate via intravenous or intraosseous access over approximately 2-5 minutes, initiated prior to trauma bay arrival and infused to completion following arrival if needed.
1 prehospital intervention session
Duration - 8 hours
Participants receive a 4-unit vasopressin bolus followed by an infusion at 0.04 U/min for eight hours, initiated within approximately 2 hours of enrollment.
Continuous infusion during hospital stay for 8 hours
Duration - Up to 30 days
Participants are monitored for outcomes including mortality, transfusion requirements, organ failure, infections, and hemostasis for up to 30 days after enrollment.
Regular assessments during hospital stay and follow-up visits up to 30 days
Trial Site Locations
Total: 15 locations
1
University of Arizona
Tucson, Arizona, United States, 85724
Actively Recruiting
2
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Actively Recruiting
3
Zuckerberg San Francisco General Hospital and Trauma Center at University of California, San Francisco
San Francisco, California, United States, 94110
Actively Recruiting
4
Denver Health Medical Center
Denver, Colorado, United States, 80204
Actively Recruiting
5
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
6
University of Maryland, Baltimore
Baltimore, Maryland, United States, 21201
Actively Recruiting
7
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
Actively Recruiting
8
University of Missouri Health Care
Columbia, Missouri, United States, 65202
Actively Recruiting
9
University of New Mexico
Albuquerque, New Mexico, United States, 87131
Actively Recruiting
10
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Actively Recruiting
11
Mount Carmel East Hospital
Columbus, Ohio, United States, 43213
Actively Recruiting
12
Allegheny Health Network
Pittsburgh, Pennsylvania, United States, 15212
Actively Recruiting
13
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
14
Texas Tech University Health Sciences Center
Lubbock, Texas, United States, 79430
Actively Recruiting
15
University of Washington Harborview Medical Center
Seattle, Washington, United States, 98104
Actively Recruiting
Research Team
J
Jason Sperry, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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