CAlcium and VAsopressin Following Injury Early Resuscitation (CAVALIER) Trial
Jason Sperry
1,050 participants
Jun 30, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria15
- 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:
- A. Systolic blood pressure ≤ 90mmHg and tachycardia (HR ≥ 108) at scene, at outside hospital, or during anticipated transport to a participating CAVALIER trial site
- OR
- B. 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:
- A. 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
- B. Systolic blood pressure ≤ 70mmHg at scene, at outside hospital, during transport, or in emergency department of a participating CAVALIER trial site
- AND
- 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)
Exclusion Criteria22
- 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
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Interventions
1 gram calcium gluconate provided via intravenous or intraosseous access over approximately 2-5 minutes
4 unit vasopressin bolus followed by vasopressin infusion at 0.04 U/min for eight hours
saline placebo volume matched to prehospital or in hospital phase
Locations(13)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05958342