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Calcium + Vasopressin for Trauma Bleeding (CAVALIER Trial)

Phase 2

Waitlist Available

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 within 24 hours of arrival plus or minus 12

Awards & highlights

CAVALIER Trial 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.Check my eligibility

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).See study design

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.

CAVALIER Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 24 hours of arrival plus or minus 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 24 hours of arrival plus or minus 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 24 hours of arrival plus or minus 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

30-day mortality

Secondary outcome measures

24-hour mortality

6-hour mortality

Blood and blood component transfusion requirements in the initial 24 hours

+10 more

CAVALIER Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Prehospital Intervention ArmExperimental Treatment1 Intervention

1 gram calcium gluconate provided intravenously 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 hospital arrival

Group III: Prehospital Control ArmPlacebo Group1 Intervention

Identical volume saline placebo to prehospital intervention arm provided intravenously over approximately 2-5 minutes, initiated prior to trauma bay arrival and infused to completion following arrival if needed

Group IV: 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 arrival

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

United States Department of DefenseFED

863 Previous Clinical Trials

226,549 Total Patients Enrolled

1 Trials studying Bleeding

30 Patients Enrolled for Bleeding

Jason SperryLead Sponsor

8 Previous Clinical Trials

5,835 Total Patients Enrolled

Jason Sperry, MDPrincipal InvestigatorUniversity of Pittsburgh

3 Previous Clinical Trials

1,230 Total Patients Enrolled

Media Library

Calcium Gluconate (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05958342 — Phase 2

Bleeding Research Study Groups: Prehospital Control Arm, Early In-Hospital Control Arm, Prehospital Intervention Arm, Early In-Hospital Intervention Arm

Bleeding Clinical Trial 2023: Calcium Gluconate Highlights & Side Effects. Trial Name: NCT05958342 — Phase 2

Calcium Gluconate (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05958342 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Might I be eligible to enroll in this research endeavor?

"Eligible candidates for this medical study must demonstrate bleeding symptoms and be between 18-90 years of age. This trial is set to include 1050 individuals in total."

Answered by AI

Has the Prehospital Intervention Arm been sanctioned by the FDA?

"Our team considers Prehospital Intervention Arm to be moderately secure with a score of 2. This is because the Phase 2 trial has clinical data upholding safety, but not yet any that establishes efficacy."

Answered by AI

Are there any opportunities to partake in this research endeavor?

"Data from clinicaltrials.gov reveals that this particular trial, posted on March 1st 2024 and edited lastly July 14th 2023 is currently not recruiting participants. Nevertheless, there are 416 other trials actively seeking volunteers right now."

Answered by AI