Calcium and vasopressin treatment for trauma patients at risk of shock

CAlcium and VAsopressin Following Injury Early Resuscitation (CAVALIER) Trial

This study is testing if giving calcium and vasopressin to trauma patients at risk of shock can help them recover better and faster.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1050 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: University of Pittsburgh (Academic / other)
• Locations: 14 sites (Tucson, Arizona and 13 other locations)
• Trial ID: NCT05958342 on ClinicalTrials.gov

What this trial studies

The CAVALIER Trial is a multi-center, double-blind trial aimed at evaluating the safety and efficacy of administering calcium gluconate prehospital and vasopressin early in the hospital for patients experiencing hemorrhagic shock. This study focuses on patients with low blood pressure and high heart rates, indicating severe trauma. By addressing hypocalcemia, which is common in these patients, the trial seeks to improve outcomes during the critical early phases of trauma care. The research will involve both prehospital and in-hospital interventions to assess their impact on patient recovery.

Who should consider this trial

Good fit: Ideal candidates include injured patients with low blood pressure and high heart rates who are at risk of hemorrhagic shock.

Not a fit: Patients who are not experiencing hemorrhagic shock or have stable vital signs may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce mortality rates in trauma patients suffering from hemorrhagic shock.

How similar studies have performed: Previous studies have indicated that early interventions in trauma care can improve outcomes, suggesting potential success for this novel approach.

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.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

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

Where this trial is running

Tucson, Arizona and 13 other locations

• University of Arizona — Tucson, Arizona, United States (Recruiting)
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States (Recruiting)
• Zuckerberg San Francisco General Hospital and Trauma Center at University of California, San Francisco — San Francisco, California, United States (Recruiting)
• Denver Health Medical Center — Denver, Colorado, United States (Recruiting)
• University of Miami — Miami, Florida, United States (Recruiting)
• Hennepin County Medical Center — Minneapolis, Minnesota, United States (Recruiting)
• University of Missouri Health Care — Columbia, Missouri, United States (Recruiting)
• University of New Mexico — Albuquerque, New Mexico, United States (Recruiting)
• The Ohio State University Wexner Medical Center — Columbus, Ohio, United States (Recruiting)
• Mount Carmel East Hospital — Columbus, Ohio, United States (Recruiting)
• Allegheny Health Network — Pittsburgh, Pennsylvania, United States (Recruiting)
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States (Recruiting)
• Texas Tech University Health Sciences Center — Lubbock, Texas, United States (Recruiting)
• University of Washington Harborview Medical Center — Seattle, Washington, United States (Recruiting)

Study contacts

• Principal investigator: Jason Sperry, MD — University of Pittsburgh
• Study coordinator: Jason Sperry, MD

Conditions Trauma; Hemorrhage; hemorrhagic shock; trauma; calcium gluconate; vasopressin