🔎 Trials Near Me

Home › Bleeding › NCT05958342

CAlcium and VAsopressin Following Injury Early Resuscitation (CAVALIER) Trial

RecruitingPhase 2

Who can join

Ages 18 to 90 · All sexes

Full eligibility criteria
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

About the study

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 is being tested

Sponsor: Jason Sperry · Participants: 1,050 · Started: Jun 30, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT05958342

Locations in the U.S.

ArizonaChandler Regional Medical Center, Chandler
University of Arizona, Tucson
ArkansasUniversity of Arkansas for Medical Sciences, Little Rock
CaliforniaZuckerberg San Francisco General Hospital and Trauma Center at University of California, San Francisco, San Francisco
ColoradoUniversity of Colorado Anschutz Medical Campus, Aurora
Denver Health Medical Center, Denver
FloridaUniversity of Miami, Miami
MarylandUniversity of Maryland, Baltimore, Baltimore
MinnesotaHennepin County Medical Center, Minneapolis
MississippiUniversity of Mississippi Medical Center, Jackson
MissouriUniversity of Missouri Health Care, Columbia
New MexicoUniversity of New Mexico, Albuquerque
OhioMount Carmel East Hospital, Columbus
The Ohio State University Wexner Medical Center, Columbus
PennsylvaniaAllegheny Health Network, Pittsburgh
University of Pittsburgh, Pittsburgh
TexasTexas Tech University Health Sciences Center, Lubbock
WashingtonUniversity of Washington Harborview Medical Center, Seattle

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.