CAlcium and VAsopressin Following Injury Early Resuscitation (CAVALIER) Trial

Launched by JASON SPERRY · Jul 14, 2023

Keywords

ClinConnect Summary

The CAVALIER Trial is a research study that aims to find out if giving calcium before reaching the hospital and vasopressin soon after arrival can help patients who are seriously injured and at risk of losing a lot of blood (hemorrhagic shock). This study will take place over four years and will involve multiple hospitals. It's open to all individuals aged between 18 to 90 years who are experiencing low blood pressure and a fast heart rate due to their injuries, and who are being transported to one of the participating hospitals for urgent care.

If you or a loved one qualify for this trial, you can expect to be part of a carefully controlled study where you may receive either the treatment being tested or standard care. Participation involves monitoring your condition closely and may lead to immediate medical interventions if needed. It's important to know that certain individuals, such as those with specific injuries or conditions, may not be eligible to participate. This trial aims to improve outcomes for patients with traumatic injuries and could potentially lead to better treatment options in the future.

Gender

ALL

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