What this study is
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's being tested
- Calcium Gluconate
Intervention · DRUG
1 gram calcium gluconate provided via intravenous or intraosseous access over approximately 2-5 minutes
- Vasopressin
Intervention · DRUG
4 unit vasopressin bolus followed by vasopressin infusion at 0.04 U/min for eight hours
- saline placebo
Intervention · DRUG
saline placebo volume matched to prehospital or in hospital phase
Study details
- Sponsor
- Jason Sperry
- Conditions
- Trauma · Hemorrhage
- Enrolling
- 1,050 people
- Starts
- 2024-06-30
- Est. completion
- 2028-03
- Design
- Quadruple-blind, randomized, sequential groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 90 YearsSex ALLHealthy volunteers Not acceptedYou 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 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; Anticipated admission to intensive care unit (ICU)
You can't join 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (18)
18 openChandler Regional Medical Center
Chandler, Arizona, United States
- Daniel Cucher, MD · Contact480-601-5411Daniel.Cucher@commonspirit.org
RecruitingUniversity of Arizona
Tucson, Arizona, United States
- Amber Rice, MD · Contact520-626-6312ARice@arizona.edu
RecruitingUniversity of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
- Joseph Margolick, MD · Contact214-620-3504Jmargolick@uams.edu
RecruitingZuckerberg San Francisco General Hospital and Trauma Center at University of California, San Francisco
San Francisco, California, United States
- Lucy Kornblith, MD · Contact415-609-6924Lucy.Kornblith@ucsf.edu
RecruitingUniversity of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
- Michael Cripps, MD, MSCS, FACS · Contact510-851-2291MICHAEL.CRIPPS@CUANSCHUTZ.EDU
RecruitingDenver Health Medical Center
Denver, Colorado, United States
- Ernest Moore, MD · Contact303-602-1820ernest.moore@dhha.org
RecruitingUniversity of Miami
Miami, Florida, United States
- Jonathan Meizoso, MD · Contact305-585-1178jpmeizoso@med.miami.edu
RecruitingUniversity of Maryland, Baltimore
Baltimore, Maryland, United States
- William Teeter, MD, MS · Contact410-328-9878William.teeter@som.umaryland.edu
RecruitingHennepin County Medical Center
Minneapolis, Minnesota, United States
- Michael Puskarich, MD, MS · Contact612-873-7448mike.puskarich@hcmed.org
RecruitingUniversity of Mississippi Medical Center
Jackson, Mississippi, United States
- Matthew Kutcher, MD, MS, FACS · Contact601-815-1312mkutcher@umc.edu
RecruitingUniversity of Missouri Health Care
Columbia, Missouri, United States
- Jeffrey Coughenour, MD · Contact573-882-1379coughenourj@health.missouri.edu
RecruitingUniversity of New Mexico
Albuquerque, New Mexico, United States
- Ming Li Wang, MD · Contact505-272-0434MLWang@salud.unm.edu
RecruitingThe Ohio State University Wexner Medical Center
Columbus, Ohio, United States
- John Loftus, MD · Contact614-685-2307John.Loftus@osumc.edu
RecruitingMount Carmel East Hospital
Columbus, Ohio, United States
- M. Chance Spalding, DO, PhD, FACS · Contact614.638.6143mcspalding62@gmail.com
RecruitingAllegheny Health Network
Pittsburgh, Pennsylvania, United States
- Philip Nawrocki, MD · Contact412-487-6590philip.nawrocki@ahn.org
RecruitingUniversity of Pittsburgh
Pittsburgh, Pennsylvania, United States
- Jason Sperry, MD · Contact412-647-3065sperryjl@upmc.edu
RecruitingTexas Tech University Health Sciences Center
Lubbock, Texas, United States
- Jayne McCauley, MD · Contact806-743-2373Jayne.mccauley@ttuhsc.edu
RecruitingUniversity of Washington Harborview Medical Center
Seattle, Washington, United States
- Andrew Latimer, MD, FAEMS · Contact206-744-5676alatim@uw.edu
Recruiting
Study team
Sponsor
Jason Sperry
Study ID STUDY23040043
Principal investigator
Jason Sperry, MD
University of Pittsburgh
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.