Recruiting
Phase 2

CAVALIER

Sponsor:

Jason Sperry

Code:

NCT05958342

Conditions

Trauma

Hemorrhage

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Calcium Gluconate

Vasopressin

saline placebo

Study Details

Brief summary:

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.

Conditions

Trauma

Hemorrhage

Study ID

NCT05958342

Start date

Jun 30, 2024

Status verified date

Aug, 2026

Completion date

Mar, 2028

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1050 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Prehospital Intervention Arm

1 gram calcium gluconate provided via intravenous or intraosseous access over approximately 2-5 minutes, initiated prior to trauma bay arrival and infused to completion following arrival if needed

placebo comparator: Prehospital Control Arm

Identical volume saline placebo to prehospital intervention arm provided via intravenous or intraosseous access over approximately 2-5 minutes, initiated prior to trauma bay arrival and infused to completion following arrival if needed

experimental: Early In-Hospital Intervention Arm

4-unit vasopressin bolus followed by a vasopressin infusion at 0.04 U/min for 8 hours. Administration of the bolus will be initiated as soon as feasible and within approximately 2 hours of enrollment. The infusion will be initiated within approximately 30 minutes of the bolus.

placebo comparator: Early In-Hospital Control Arm

volume matched saline bolus followed by volume matched normal saline placebo infusion for eight hours initiated within approximately two hours of enrollment

Interventions

Calcium Gluconate

1 gram calcium gluconate provided via intravenous or intraosseous access over approximately 2-5 minutes

Vasopressin

4 unit vasopressin bolus followed by vasopressin infusion at 0.04 U/min for eight hours

saline placebo

saline placebo volume matched to prehospital or in hospital phase

Primary outcome measure

  • Number of participants with 30-day mortality [ Time Frame: from randomization to death or 30 days, whichever comes first ]

Central Contacts and Locations

Central contacts

Locations

Chandler Regional Medical Center

Recruiting

Chandler, Arizona, United States, 85224

Contacts

University of Arizona

Recruiting

Tucson, Arizona, United States, 85724

Contacts

University of Arkansas for Medical Sciences

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Zuckerberg San Francisco General Hospital and Trauma Center at University of California, San Francisco

Recruiting

San Francisco, California, United States, 94110

Contacts

Denver Health Medical Center

Recruiting

Denver, Colorado, United States, 80204

Contacts

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

University of Maryland, Baltimore

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Hennepin County Medical Center

Recruiting

Minneapolis, Minnesota, United States, 55415

Contacts

Michael Puskarich, MD, MS

612-873-7448mike.puskarich@hcmed.org

University of Missouri Health Care

Recruiting

Columbia, Missouri, United States, 65202

Contacts

University of New Mexico

Recruiting

Albuquerque, New Mexico, United States, 87131

Contacts

The Ohio State University Wexner Medical Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Mount Carmel East Hospital

Recruiting

Columbus, Ohio, United States, 43213

Contacts

M. Chance Spalding, DO, PhD, FACS

614.638.6143mcspalding62@gmail.com

Allegheny Health Network

Recruiting

Pittsburgh, Pennsylvania, United States, 15212

Contacts

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Texas Tech University Health Sciences Center

Recruiting

Lubbock, Texas, United States, 79430

Contacts

University of Washington Harborview Medical Center

Recruiting

Seattle, Washington, United States, 98104

Contacts

Andrew Latimer, MD, FAEMS

206-744-5676alatim@uw.edu

More Information

Sponsor

Jason Sperry

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Keywords

  • hemorrhagic shock
  • trauma
  • calcium gluconate
  • vasopressin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Jason Sperry on 2026-08-06.