CAlcium and VAsopressin Following Injury Early Resuscitation (CAVALIER) Trial

What Was Tested

The trial (phase 2) is built around Vasopressin.

It had four arms (groups): Prehospital Intervention Arm (experimental), Prehospital Control Arm (placebo comparator), Early In-Hospital Intervention Arm (experimental) and Early In-Hospital Control Arm (placebo comparator).

Identical volume saline placebo to prehospital intervention arm provided via intravenous or intraosseous access over approximately 2-5 minutes, initiated prior to trauma bay arrival and infused to completion following arrival if needed.

The registry classes the interventions as drug.

More on the Plan

Resuscitation strategies for the acutely injured patient in hemorrhagic shock have evolved.

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.

Hypocalcemia following traumatic injury is exceedingly common following severe traumatic injury in patients at risk of hemorrhagic shock.

Who Took Part

Enrollment: 1050 planned participants were the target.

It was open to people of any sex aged from 18 years up to 90 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Blood/blood component transfusion initiated in prehospital setting or deemed clinically indicated within 60 minutes of arrival at the enrolling trauma center.

The full record lists 1 inclusion and 20 exclusion criteria; among the exclusions: wearing no cavalier opt-out bracelet; age \> 90 or \< 18 years of age; isolated fall from standing injury mechanism.

How the Study Was Run

Design: randomized, sequential and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got Vasopressin and who got the comparison, which limits bias.

Neither the participants nor the staff measuring them knew who was on Vasopressin, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2024-06-30 with completion listed for 2027-03.

It ran at 18 sites in United States (18).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of participants with 30-day mortality.

It also tracked 15 secondary outcomes, for example Number of participants with 6-hour mortality, Number of participants with 24-hour mortality, Number of participants with In-hospital mortality, Blood and blood component transfusion requirements in the initial 6 hours, Blood and blood component transfusion requirements in the initial 24 hours and Incidence of Multiple Organ Failure (MOF).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Vasopressin in 1050 people.

With 1050 participants it is a large trial for this field.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Vasopressin compound page, all human trials.