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CAlcium and VAsopressin Following Injury Early Resuscitation (CAVALIER) Trial

ConditionsTraumaHemorrhage
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-90
SponsorJason Sperry

About this trial

The CAlcium and VAsopressin following Injury Early Resuscitation (CAVALIER) Trial is a proposed 4 year, double-blind, mutli-center, prehospital and early in hospital phase randomized trial designed to determine the efficacy and safety of prehospital calcium and early in hospital vasopressin in patients at risk of hemorrhagic shock.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Wearing NO CAVALIER opt-out bracelet

Age > 90 or < 18 years of age

Isolated fall from standing injury mechanism

Known prisoner

Trial design

Design model

Sequential

Treatments tested in this trial

  • Calcium Gluconate

    Drug

    1 gram calcium gluconate provided via intravenous or intraosseous access over approximately 2-5 minutes

  • Vasopressin

    Drug

    4 unit vasopressin bolus followed by vasopressin infusion at 0.04 U/min for eight hours

  • saline placebo

    Drug

    saline placebo volume matched to prehospital or in hospital phase

Treatment groups

1,050 Participants
are divided into 4 treatment groups
Group A: Prehospital Intervention ArmExperimental treatment 1 intervention
Group B: Prehospital Control ArmPlacebo comparator 1 intervention
Group C: Early In-Hospital Intervention ArmExperimental treatment 1 intervention
Group D: Early In-Hospital Control ArmPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants with 30-day mortality

all cause mortality within 30 days

Time frame
from randomization to death or 30 days, whichever comes first

Secondary outcomes

1

Number of participants with 6-hour mortality

all cause mortality within 6 hours

Time frame
from randomization to death or 6 hours, whichever comes first
2

Number of participants with 24-hour mortality

all cause mortality within 24 hours

Time frame
from randomization to death or 24 hours, whichever comes first
3

Number of participants with In-hospital mortality

death prior to hospital discharge

Time frame
In hospital mortality from time of randomization to death or 30 days, whichever comes first
4

Number of participants with Death from hemorrhage

Death from hemorrhage adjudicated by the site investigator

Time frame
from randomization to death or 30 days, whichever comes first

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jason Sperry

Lead sponsor

University of Pittsburgh

Sponsor institution

United States Department of Defense

Collaborator

Source ClinicalTrials.gov
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