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Calcium + Vasopressin for Trauma Bleeding (CAVALIER Trial)

Phase 2

Recruiting

Led By Jason Sperry, MD

Research Sponsored by Jason Sperry

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured in the first 60 minutes (+/- 3 hours), when feasible, during early stage resuscitation in emergency department or operating room

Summary

This trial will study if a drug combo can help people in danger of bleeding to death after trauma.

Who is the study for?

The CAVALIER trial is for adults aged 18-90 who have experienced trauma leading to a risk of hemorrhagic shock. Eligible participants must have low blood pressure and/or high heart rate, require a blood transfusion within an hour of arriving at the hospital, and be expected to go into surgery quickly upon arrival. Pregnant individuals, prisoners, those with severe brain injuries or certain types of accidents are excluded.

What is being tested?

This study tests whether giving calcium gluconate before reaching the hospital and vasopressin shortly after arrival can help patients at risk of bleeding out from trauma. Participants will either receive these drugs or saline placebos in a randomized manner without knowing which one they're getting (double-blind).

What are the potential side effects?

Possible side effects may include allergic reactions to the medications, changes in blood pressure, abnormal heart rhythms, or irritation at the injection site. Since this is a trial for emergency treatment in severely injured patients, monitoring for side effects will be continuous.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured in the first 60 minutes (+/- 3 hours), when feasible, during early stage resuscitation in emergency department or operating room

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured in the first 60 minutes (+/- 3 hours), when feasible, during early stage resuscitation in emergency department or operating room

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured in the first 60 minutes (+/- 3 hours), when feasible, during early stage resuscitation in emergency department or operating room for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants with 30-day mortality

Secondary study objectives

Blood and blood component transfusion requirements in the initial 24 hours

Blood and blood component transfusion requirements in the initial 6 hours

Hospital free days

+11 more

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Prehospital Intervention ArmExperimental Treatment1 Intervention

1 gram calcium gluconate 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

Group II: Early In-Hospital Intervention ArmExperimental Treatment1 Intervention

4 unit vasopressin bolus followed by a vasopressin infusion at 0.04 U/min for eight hours, initiated within approximately two hours of enrollment

Group III: Early In-Hospital Control ArmPlacebo Group1 Intervention

volume matched saline bolus followed by volume matched normal saline placebo infusion for eight hours initiated within approximately two hours of enrollment

Group IV: Prehospital Control ArmPlacebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vasopressin

2014

Completed Phase 4

~24780

Calcium Gluconate

2023

Completed Phase 3

~460