A Phase 2 interventional study of Calcium Gluconate and Vasopressin in Trauma and Hemorrhage, sponsored by Jason Sperry. Recruiting at 18 sites in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Jason Sperry · Phase 2, Interventional, and Treatment
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.
Resuscitation strategies for the acutely injured patient in hemorrhagic shock have evolved. Patients benefit from receiving less crystalloid in favor of blood transfusions with balanced ratios of plasma and platelets or whole blood resuscitation. 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. Despite these changes, deaths from traumatic hemorrhage continue to occur in the first hours following trauma center arrival, underscoring the importance of early, novel interventions.
Hypocalcemia following traumatic injury is exceedingly common following severe traumatic injury in patients at risk of hemorrhagic shock. During hemorrhagic shock resuscitation, pathways reliant upon calcium such as platelet function, intrinsic and extrinsic hemostasis, and cardiac contractility are disrupted. Citrate containing transfusion products are known to further reduce calcium levels through chelation during trauma resuscitation. Hypocalcemia has consistently been shown to be independently associated with the risk of large volume blood transfusion and mortality. Current management practices include calcium replacement during the in hospital phase of care in patients receiving blood products. Early calcium replacement in patients at risk of hemorrhage and hypocalcemia may mitigate coagulopathy, maintain hemostasis, improve hemodynamics and outcomes, and may reduce complications attributable to hemorrhagic shock.
Arginine vasopressin is a physiologic hormone released by the posterior pituitary in response to hypotension and is commonly used as a vasopressor for critically ill patients for the treatment of hypotension due to multiple causes including sepsis. Prolonged hemorrhagic shock has the potential to alter systemic vasomotor tone which can progress to refractory/recalcitrant hypotension. Patients receiving resuscitation for hemorrhage are at risk of vasopressin deficiency. Vasopressin may improve hemostasis by enhancing platelet function and augmenting clot formation. Vasopressin infusion soon after injury in patients in hemorrhagic shock has been demonstrated to be safe and result in a reduction in blood transfusion requirements and a lower incidence of deep venous thrombosis.
Whole blood, red cells, and blood components are a precious and limited resource. Trauma resuscitation adjuncts such as early calcium and vasopressin may provide benefit when transfusion products are limited and may provide additional benefit even when transfusion capabilities remain robust. Due to their action on coagulation and hemodynamic cascades in the injured patient, these resuscitation adjuncts have the potential to interact and provide additive benefit to the injured patient. However, safety and efficacy of prehospital calcium and early in hospital vasopressin remain inadequately characterized. Enrolled patients may participate in the prehospital phase (calcium), in-hospital phase (vasopressin), or both. The aims of the CAlcium and VAsopressin following Injury Early Resuscitation (CAVALIER) trial are to determine the efficacy and safety of prehospital calcium supplementation and early in hospital vasopressin infusion as compared to standard care resuscitation in patients at risk of hemorrhagic shock and to appropriately characterize any additive effect of both resuscitation adjunct interventions.
2,217 studies on the registry are indexed under Wounds and Injuries; 441 are open to participants now.
This study's planned enrollment of 1,050 is above the median of 70 across 1,424 interventional studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →Jason Sperry is the lead sponsor of 10 studies on the registry; 3 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
OR
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
OR
1B. Systolic blood pressure ≤ 70mmHg at scene, at outside hospital, during transport, or in emergency department of a participating CAVALIER trial site
AND
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 trauma center
AND
4. Anticipated admission to intensive care unit (ICU)
Exclusion Criteria:
Prehospital Phase
Early In-Hospital Phase:
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
Drug: Calcium Gluconate
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
Drug: saline placebo
4-unit vasopressin bolus followed by a vasopressin infusion at 0.04 U/min for 8 hours. Administration of the bolus will be initiated as soon as feasible and within approximately 2 hours of enrollment. The infusion will be initiated within approximately 30 minutes of the bolus.
Drug: Vasopressin
volume matched saline bolus followed by volume matched normal saline placebo infusion for eight hours initiated within approximately two hours of enrollment
Drug: saline placebo
1 gram calcium gluconate provided via intravenous or intraosseous access over approximately 2-5 minutes
4 unit vasopressin bolus followed by vasopressin infusion at 0.04 U/min for eight hours
saline placebo volume matched to prehospital or in hospital phase
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
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
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
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
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
Number of participants with Death from brain injury
Death from brain injury adjudicated by the site investigator
Time frame: from randomization to death or 30 days, whichever comes first
Blood and blood component transfusion requirements in the initial 6 hours
number of units transfused and type
Time frame: from randomization to 6 hours
Blood and blood component transfusion requirements in the initial 24 hours
number of units transfused and type
Time frame: from randomization to 24 hours
Incidence of Multiple Organ Failure (MOF)
Evaluated via the Denver Post injury Multiple Organ Failure Score, characterized as an incidence rate (percentage) and as MOF free days. Patients never admitted to ICU or with length of stay less than 48 hours will have a score of 0. A summary Denver score of \>3 will be classified as MOF.
Time frame: Scores determined daily until up to Day 7 or ICU discharge, whichever comes first
Incidence of nosocomial infection
Utilizing the CDC criteria for diagnosis of hospital acquired pneumonia and blood stream infection
Time frame: from randomization to death or 30 days
Time to hemostasis
Determined by ability to reach nadir transfusion requirement of 1 unit of red blood cells in a 60 minute period in the first 4 hours following arrival. In the absence of ability to obtain hemostasis within the first 4 hours, the patient will be designated "non-hemostasis"
Time frame: hospital arrival to 4 hours
Incidence of coagulopathy by thromboelastography (TEG)
TEG date collected only when obtained as part of clinical
Time frame: within 4 hours of arrival plus or minus 12
Incidence of coagulopathy by thromboelastography (TEG)
TEG date collected only when obtained as part of clinical
Time frame: within 24 hours of arrival plus or minus 12
ICU free days
number of days the patient is alive and not admitted to ICU subtracted from 30
Time frame: From hospital arrival to death or 30 days
Hospital free days
number of days the patient is alive and not admitted to hospital subtracted from 30
Time frame: From hospital arrival to death or 30 days
Ionized calcium measurements
Ionized calcium collected as part of clinical care or as research lab
Time frame: Measured in the first 60 minutes (+/- 3 hours), when feasible, during early stage resuscitation in emergency department or operating room
Plan to share: Yes — De-identified data may be shared with the funding agency as well as other researchers upon request to the Principal Investigator
Supporting information: Study protocol, Informed consent form
Time frame: Data will become available after publication of the primary manuscript
Access criteria: Requests for data will be submitted in writing and reviewed by the Principal Investigator
No publications or documents are linked to this record.
Started Jun 2024 (actual). Primary completion is estimated for Mar 2027, 33 months after the start.
Of 42 non-industry phase 2 interventional studies under Wounds and Injuries, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 92. This study's planned 33 months is close to that.
Counting every sponsor, half of 47 studies reached it within 35 months; a quarter within 25 and three quarters within 92.
Wounds and Injuries covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drugs tested here: Calcium Gluconate · Arginine Vasopressin
Jason Sperry