CAlcium and VAsopressin Following Injury Early Resuscitation (CAVALIER) Trial
Jason Sperry
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.
Description
Resuscitation strategies for the acutely injured patient in hemorrhagic shock have evolved. Patients benefit from receiving less crystalloid in favor of blood transfusions with balanced ratios of plasma and platelets or whole blood resuscitation. These resuscitation practices are termed Damage Control Resuscitation and have been incorporated into resuscitation protocols in Level I trauma centers across the country. Damage Control Resuscitation represents standard practice for military and civilian trauma. Despite these changes, deaths from traumatic hemorrhage continue to occur in the first ho…
Eligibility
- Age range
- 18–90 years
- Sex
- All
- Healthy volunteers
- No
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 si…
Interventions
- DrugCalcium Gluconate
1 gram calcium gluconate provided via intravenous or intraosseous access over approximately 2-5 minutes
- DrugVasopressin
4 unit vasopressin bolus followed by vasopressin infusion at 0.04 U/min for eight hours
- Drugsaline placebo
saline placebo volume matched to prehospital or in hospital phase
Locations (14)
- University of ArizonaTucson, Arizona
- University of Arkansas for Medical SciencesLittle Rock, Arkansas
- Zuckerberg San Francisco General Hospital and Trauma Center at University of California, San FranciscoSan Francisco, California
- Denver Health Medical CenterDenver, Colorado
- University of MiamiMiami, Florida
- Hennepin County Medical CenterMinneapolis, Minnesota