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Phase 2
Age: 18Years - 90Years
All Genders
ID05958342

Study of Early Calcium and Vasopressin Treatment in Trauma Patients at Risk of Severe Bleeding

Led by Jason Sperry · Updated on 2026-08-06

1050

Participants Needed

16

Research Sites

52 weeks

Total Duration

On this page

Sponsors

J

Jason Sperry

Lead Sponsor

U

United States Department of Defense

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness and safety of early calcium and vasopressin treatment for patients at risk of hemorrhagic shock following traumatic injury. This phase 2, double-blind, multi-center trial focuses on improving resuscitation methods to reduce death and complications caused by severe blood loss. Despite advances in damage control resuscitation, deaths from traumatic hemorrhage remain high, highlighting the need for new early interventions. The study compares prehospital administration of 1 gram calcium gluconate given intravenously or intraosseously before hospital arrival with a saline placebo. In the early hospital phase, participants receive either a vasopressin bolus followed by an 8-hour infusion or a saline placebo infusion. These interventions aim to improve blood clotting, heart function, and blood pressure during trauma resuscitation. Patients may participate in either or both phases depending on their condition and timing. Participants undergo screening and then receive treatment while researchers monitor their health and outcomes. Assessments include survival rates up to 30 days, blood transfusion needs, organ failure, infections, blood clotting tests, and calcium levels. The study measures how these treatments affect mortality, complications, and recovery in trauma patients. Safety and efficacy data will be collected throughout the trial, which lasts up to four years.

CONDITIONS

Brief Title

CAlcium and VAsopressin Following Injury Early Resuscitation (CAVALIER) Trial

Who Can Participate

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Injured patients aged 18 to 90 years at risk of hemorrhagic shock
  • Systolic blood pressure ≤ 90 mmHg and heart rate ≥ 108 at scene, outside hospital, or during transport
  • OR systolic blood pressure ≤ 70 mmHg at scene, outside hospital, or during transport
  • Blood or blood component transfusion started prehospital or within 60 minutes of hospital arrival
  • Clinical indication for major hemorrhage control surgery within 60 minutes of hospital arrival
  • Anticipated admission to intensive care unit (ICU)
Not Eligible

You will not qualify if you...

  • Wearing a CAVALIER opt-out bracelet
  • Age less than 18 or greater than 90 years
  • Injury from isolated fall from standing height
  • Known prisoner status
  • Known pregnancy
  • Traumatic arrest with more than 5 minutes of CPR without return of vital signs
  • Brain matter exposed or penetrating brain injury
  • Isolated drowning or hanging victims
  • Objection to study participation by patient or family
  • Inability to obtain intravenous or intraosseous access

Research Team

J

Jason Sperry, MD

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