CAlcium and VAsopressin Following Injury Early Resuscitation (CAVALIER) Trial

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Jason Sperry
Study ID
NCT05958342
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Hemorrhage
  • Trauma

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Calcium Gluconate — DRUG
    1 gram calcium gluconate provided via intravenous or intraosseous access over approximately 2-5 minutes
  • Vasopressin — DRUG
    4 unit vasopressin bolus followed by vasopressin infusion at 0.04 U/min for eight hours
  • saline placebo — DRUG
    saline placebo volume matched to prehospital or in hospital phase

Study Details

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.

Key Dates

Start date
Jun 30, 2024
Status verified
Jun 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2028

Study Design

Enrollment
1,050 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

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

Primary Outcome Measure

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

Central Contacts

Locations (15)

FacilityCityStateZIPSite coordinators
University of ArizonaTucsonArizona85724
Bellal Joseph, MD
[email protected]
520-626-5056
University of Arkansas for Medical SciencesLittle RockArkansas72205
Joseph Margolick, MD
[email protected]
214-620-3504
Zuckerberg San Francisco General Hospital and Trauma Center at University of California, San FranciscoSan FranciscoCalifornia94110
Lucy Kornblith, MD
[email protected]
415-609-6924
Denver Health Medical CenterDenverColorado80204
Ernest Moore, MD
[email protected]
303-602-1820
University of MiamiMiamiFlorida33136
Jonathan Meizoso, MD
[email protected]
305-585-1178
University of Maryland, BaltimoreBaltimoreMaryland21201
William Teeter, MD, MS
[email protected]
410-328-9878
Hennepin County Medical CenterMinneapolisMinnesota55415
Michael Puskarich, MD, MS
[email protected]
612-873-7448
University of Missouri Health CareColumbiaMissouri65202
Jeffrey Coughenour, MD
[email protected]
573-882-1379
University of New MexicoAlbuquerqueNew Mexico87131
Ming Li Wang, MD
[email protected]
505-272-0434
Mount Carmel East HospitalColumbusOhio43213
M. Chance Spalding, DO, PhD, FACS
[email protected]
614.638.6143
The Ohio State University Wexner Medical CenterColumbusOhio43210
John Loftus, MD
[email protected]
614-685-2307
Allegheny Health NetworkPittsburghPennsylvania15212
Philip Nawrocki, MD
[email protected]
412-487-6590
University of PittsburghPittsburghPennsylvania15213
Jason Sperry, MD
[email protected]
4126473065
Texas Tech University Health Sciences CenterLubbockTexas79430
Jayne McCauley, MD
[email protected]
806-743-2373
University of Washington Harborview Medical CenterSeattleWashington98104
Andrew Latimer, MD, FAEMS
[email protected]
206-744-5676

Find similar trials in Tucson, AZ

By research site
University of Arizona· Tucson, AZUniversity of Arkansas for Medical Sciences· Little Rock, ARZuckerberg San Francisco General Hospital and Trauma Center at University of California, San Francisco· San Francisco, CADenver Health Medical Center· Denver, COUniversity of Miami· Miami, FLUniversity of Maryland, Baltimore· Baltimore, MD

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