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Recruiting Phase 2 NCT05958342

CAlcium and VAsopressin Following Injury Early Resuscitation (CAVALIER) Trial

Trial Parameters

Condition Trauma
Sponsor Jason Sperry
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 1,050
Sex ALL
Min Age 18 Years
Max Age 90 Years
Start Date 2024-06-30
Completion 2027-03
All Conditions
Interventions
Calcium GluconateVasopressinsaline placebo

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.

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.Bl

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