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CAlcium and VAsopressin Following Injury Early Resuscitation (CAVALIER) Trial

Sponsored by Jason Sperry

About this 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.

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 hours following trauma center arrival, underscoring the importance of early, novel interventions. Hypocalcemia following traumatic injury is exceedingly common following severe traumatic injury in pati…

Where this study is enrolling (17)

  • University of Arizona

    Tucson, Arizona

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  • Chandler Regional Medical Center

    Chandler, Arizona

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  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas

    I'm interested

  • Zuckerberg San Francisco General Hospital and Trauma Center at University of California, San Francisco

    San Francisco, California

    I'm interested

  • Denver Health Medical Center

    Denver, Colorado

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Show all 17 locations
Who can participate

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
  • ✓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
  • ✓1B. Systolic blood pressure ≤ 70mmHg at scene, at outside hospital, during transport, or in emergency department of a participating CAVALIER trial site
  • ✓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
  • ✓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

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.