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New treatment option for Trauma
Official title CAlcium and VAsopressin Following Injury Early Resuscitation (CAVALIER) Trial
ClinicalTrials.gov ID: NCT05958342
What this study is testing
What is Calcium Gluconate?
Calcium Gluconate is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for trauma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join if
- Prehospital Phase:
- Injured patients at risk of hemorrhagic shock being transported from scene or referral hospital to a participating CAVALIER trial site who meet the...
- 1A. Systolic blood pressure ≤ 90mmHg and tachycardia (HR ≥ 108) at scene, at outside hospital, or during anticipated transport to a participating...
- 1B. Systolic blood pressure ≤ 70mmHg at scene, at outside hospital, or during anticipated transport to a participating CAVALIER trial site
- Early In-Hospital Phase:
You likely can't join if
- Prehospital Phase
- Wearing NO CAVALIER opt-out bracelet
- Age \> 90 or \< 18 years of age
- Isolated fall from standing injury mechanism
- Known prisoner
- Known pregnancy
See the full eligibility criteria
- Prehospital Phase:
- Injured patients at risk of hemorrhagic shock being transported from scene or referral hospital to a participating CAVALIER trial site who meet the following criteria:
- 1A. Systolic blood pressure ≤ 90mmHg and tachycardia (HR ≥ 108) at scene, at outside hospital, or during anticipated transport to a participating CAVALIER trial site
- 1B. Systolic blood pressure ≤ 70mmHg at scene, at outside hospital, or during anticipated transport to a participating CAVALIER trial site
- Early In-Hospital Phase:
- Injured patients at a participating CAVALIER trial site at risk of hemorrhagic shock who meet the following criteria:
- 1A. Systolic blood pressure ≤ 90mmHg and tachycardia (HR ≥ 108) at scene, at outside hospital, during transport, or in emergency department of a participating CAVALIER trial site
- 1B. Systolic blood pressure ≤ 70mmHg at scene, at outside hospital, during transport, or in emergency department of a participating CAVALIER trial site
- 2.Blood/blood component transfusion initiated in prehospital setting or deemed clinically indicated within 60 minutes of arrival at the enrolling trauma center
- AND 3. Clinical team deems Operating Room for major hemorrhage control procedure (e.g., laparotomy, thoracotomy, vascular exploration or extremity amputation) indicated within 60 minutes of arrival at the enrolling...
- 4\. Anticipated admission to intensive care unit (ICU)
- Prehospital Phase
- Wearing NO CAVALIER opt-out bracelet
- Age \> 90 or \< 18 years of age
- Isolated fall from standing injury mechanism
- Known prisoner
- Known pregnancy
- Traumatic arrest with \> 5 minutes of CPR without return of vital signs
- Brain matter exposed or penetrating brain injury
- Isolated drowning or hanging victims
- Objection to study voiced by subject or family member at the scene or at the trauma center
- Inability to obtain IV/IO access Early In-Hospital Phase:
- Wearing NO CAVALIER opt-out bracelet
- Age \> 90 or \< 18 years of age
- Isolated fall from standing injury mechanism
- Known prisoner
- Known pregnancy
- Traumatic arrest with \> 5 minutes of CPR without return of vital signs
- Brain matter exposed or penetrating brain injury
- Isolated drowning or hanging victims
- Objection to study voiced by subject or family member at the scene or at the trauma center
- Inability to obtain IV access
The study team makes the final eligibility decision.
Where it's taking place
- Tucson, Arizona, United States
- Little Rock, Arkansas, United States
- San Francisco, California, United States
- Denver, Colorado, United States
- Miami, Florida, United States
- Baltimore, Maryland, United States
- Minneapolis, Minnesota, United States
- Columbia, Missouri, United States
- Albuquerque, New Mexico, United States
- Columbus, Ohio, United States
- Pittsburgh, Pennsylvania, United States
- Lubbock, Texas, United States
- Seattle, Washington, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tucson, Arizona, United States; Little Rock, Arkansas, United States; San Francisco, California, United States; Denver, Colorado, United States; Miami, Florida, United States; Baltimore, Maryland, United States and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.