CAlcium and VAsopressin Following Injury Early Resuscitation (CAVALIER) Trial

NCT05958342 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: STUDY23040043W81XWH-6-D-0024
• Study Type: interventional
• Target: 1,050
• Locations: 1 country
• Sites: 15

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

Keywords

hemorrhagic shock; trauma; calcium gluconate; vasopressin

Outcome Measures

Primary Outcomes (1)

• Number of participants with 30-day mortality

  all cause mortality within 30 days

  from randomization to death or 30 days, whichever comes first

Secondary Outcomes (15)

• Number of participants with 6-hour mortality

  from randomization to death or 6 hours, whichever comes first

• Number of participants with 24-hour mortality

  from randomization to death or 24 hours, whichever comes first

• Number of participants with In-hospital mortality

  In hospital mortality from time of randomization to death or 30 days, whichever comes first

• Number of participants with Death from hemorrhage

  from randomization to death or 30 days, whichever comes first

• Number of participants with Death from brain injury

  from randomization to death or 30 days, whichever comes first

Study Arms (4)

Prehospital Intervention Arm

EXPERIMENTAL

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

Drug: Calcium Gluconate

Prehospital Control Arm

PLACEBO COMPARATOR

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

Drug: saline placebo

Early In-Hospital Intervention Arm

EXPERIMENTAL

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.

Drug: Vasopressin

Early In-Hospital Control Arm

PLACEBO COMPARATOR

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

Drug: saline placebo

Interventions

saline placebo DRUG

saline placebo volume matched to prehospital or in hospital phase

Early In-Hospital Control Arm; Prehospital Control Arm

Calcium Gluconate DRUG

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

Prehospital Intervention Arm

Vasopressin DRUG

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

Early In-Hospital Intervention Arm

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:
• A. Systolic blood pressure ≤ 90mmHg and tachycardia (HR ≥ 108) at scene, at outside hospital, or during anticipated transport to a participating CAVALIER trial site
• B. 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:
• A. 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
• B. 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

Sponsors & Collaborators

• United States Department of Defense: collaborator
• Jason Sperry: lead

Study Sites (15)

University of Arizona

Tucson, Arizona, 85724, United States

RECRUITING

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

RECRUITING

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

San Francisco, California, 94110, United States

RECRUITING

Denver Health Medical Center

Denver, Colorado, 80204, United States

RECRUITING

University of Miami

Miami, Florida, 33136, United States

RECRUITING

University of Maryland, Baltimore

Baltimore, Maryland, 21201, United States

RECRUITING

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

RECRUITING

University of Missouri Health Care

Columbia, Missouri, 65202, United States

RECRUITING

University of New Mexico

Albuquerque, New Mexico, 87131, United States

RECRUITING

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

RECRUITING

Mount Carmel East Hospital

Columbus, Ohio, 43213, United States

RECRUITING

Allegheny Health Network

Pittsburgh, Pennsylvania, 15212, United States

RECRUITING

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Texas Tech University Health Sciences Center

Lubbock, Texas, 79430, United States

RECRUITING

University of Washington Harborview Medical Center

Seattle, Washington, 98104, United States

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries; Hemorrhage; Shock, Hemorrhagic; Diabetes Insipidus

Interventions

Calcium Gluconate; Vasopressins

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Gluconates; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Jason Sperry, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jason Sperry, MD

CONTACT

4128028270; sperryjl@upmc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: In-Hospital phase: permuted block design

Study Record Dates

• First Submitted: July 14, 2023
• First Posted: July 24, 2023
• Study Start: June 30, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: June 3, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will become available after publication of the primary manuscript
• Access Criteria: Requests for data will be submitted in writing and reviewed by the Principal Investigator

Locations

US (15)