TraumaPhase 2CAVALIERNCT05958342
CAlcium and VAsopressin Following Injury Early Resuscitation (CAVALIER) Trial
A Phase 2 study testing Calcium Gluconate and Vasopressin in people with Trauma and Hemorrhage, run by Jason Sperry at 18 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Trauma, Hemorrhage
- What is being tested?
- Calcium Gluconate and Vasopressin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,050 participants
- Where
- 18 sitesUnited States
- Study dates
- 30 Jun 2024to Mar 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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)
Who cannot join
- 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
Show all 22Show fewer
- 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
Trial locations and contacts
18 sites in 1 country. Contact the study team or a site near you to ask about taking part.
18 sites in 1 country
United States18 sites, 18 recruiting
- Recruiting
University of New Mexico
Albuquerque, New Mexico, 87131
Ming Li Wang, MD, 505-272-0434, MLWang@salud.unm.edu
- Recruiting
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Michael Cripps, MD, MSCS, FACS, 510-851-2291, MICHAEL.CRIPPS@CUANSCHUTZ.EDU
- Recruiting
University of Maryland, Baltimore
Baltimore, Maryland, 21201
William Teeter, MD, MS, 410-328-9878, William.teeter@som.umaryland.edu
- Recruiting
Chandler Regional Medical Center
Chandler, Arizona, 85224
Daniel Cucher, MD, 480-601-5411, Daniel.Cucher@commonspirit.org
- Recruiting
University of Missouri Health Care
Columbia, Missouri, 65202
Jeffrey Coughenour, MD, 573-882-1379, coughenourj@health.missouri.edu
- Recruiting
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
John Loftus, MD, 614-685-2307, John.Loftus@osumc.edu
- Recruiting
Mount Carmel East Hospital
Columbus, Ohio, 43213
M. Chance Spalding, DO, PhD, FACS, 614.638.6143, mcspalding62@gmail.com
- Recruiting
Denver Health Medical Center
Denver, Colorado, 80204
Ernest Moore, MD, 303-602-1820, ernest.moore@dhha.org
- Recruiting
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Matthew Kutcher, MD, MS, FACS, 601-815-1312, mkutcher@umc.edu
- Recruiting
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Joseph Margolick, MD, 214-620-3504, Jmargolick@uams.edu
- Recruiting
Texas Tech University Health Sciences Center
Lubbock, Texas, 79430
Jayne McCauley, MD, 806-743-2373, Jayne.mccauley@ttuhsc.edu
- Recruiting
University of Miami
Miami, Florida, 33136
Jonathan Meizoso, MD, 305-585-1178, jpmeizoso@med.miami.edu
- Recruiting
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
Michael Puskarich, MD, MS, 612-873-7448, mike.puskarich@hcmed.org
- Recruiting
Allegheny Health Network
Pittsburgh, Pennsylvania, 15212
Philip Nawrocki, MD, 412-487-6590, philip.nawrocki@ahn.org
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Jason Sperry, MD, 412-647-3065, sperryjl@upmc.edu
- Recruiting
Zuckerberg San Francisco General Hospital and Trauma Center at University of California, San Francisco
San Francisco, California, 94110
Lucy Kornblith, MD, 415-609-6924, Lucy.Kornblith@ucsf.edu
- Recruiting
University of Washington Harborview Medical Center
Seattle, Washington, 98104
Andrew Latimer, MD, FAEMS, 206-744-5676, alatim@uw.edu
- Recruiting
University of Arizona
Tucson, Arizona, 85724
Amber Rice, MD, 520-626-6312, ARice@arizona.edu
About this study
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.
Read the detailed description
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.
- Conditions
- Trauma, Hemorrhage
- Being tested
- Calcium Gluconate, Vasopressin, saline placebo
- Keywords
- hemorrhagic shock, trauma, calcium gluconate, vasopressin
- Medical subject headings
- Wounds and Injuries, Hemorrhage, Shock, Hemorrhagic, Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium GluconateDrug
1 gram calcium gluconate provided via intravenous or intraosseous access over approximately 2-5 minutes
VasopressinDrug
4 unit vasopressin bolus followed by vasopressin infusion at 0.04 U/min for eight hours
saline placeboDrug
saline placebo volume matched to prehospital or in hospital phase
| Study group | Role | What they receive |
|---|---|---|
| Prehospital Intervention Arm | Experimental | 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 Receives: Drug: Calcium Gluconate |
| Prehospital Control Arm | Placebo comparator | 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 Receives: Drug: saline placebo |
| Early In-Hospital Intervention Arm | Experimental | 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. Receives: Drug: Vasopressin |
| Early In-Hospital Control Arm | Placebo comparator | volume matched saline bolus followed by volume matched normal saline placebo infusion for eight hours initiated within approximately two hours of enrollment Receives: Drug: saline placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with 30-day mortality
all cause mortality within 30 days
Measured: from randomization to death or 30 days, whichever comes first
Secondary outcomes (15)
Number of participants with 6-hour mortality
all cause mortality within 6 hours
Measured: from randomization to death or 6 hours, whichever comes first
Number of participants with 24-hour mortality
all cause mortality within 24 hours
Measured: from randomization to death or 24 hours, whichever comes first
Number of participants with In-hospital mortality
death prior to hospital discharge
Measured: 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
Measured: 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
Measured: 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
Measured: from randomization to 6 hours
Blood and blood component transfusion requirements in the initial 24 hours
number of units transfused and type
Measured: 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.
Measured: 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
Measured: 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"
Measured: hospital arrival to 4 hours
Incidence of coagulopathy by thromboelastography (TEG)
TEG date collected only when obtained as part of clinical
Measured: 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
Measured: 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
Measured: 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
Measured: From hospital arrival to death or 30 days
Ionized calcium measurements
Ionized calcium collected as part of clinical care or as research lab
Measured: Measured in the first 60 minutes (+/- 3 hours), when feasible, during early stage resuscitation in emergency department or operating room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start30 Jun 2024
- Primary completionMar 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- In-Hospital phase: permuted block design
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,050 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jason Sperry
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor-investigator, Jason Sperry, University of Pittsburgh
- Investigators
- Jason Sperry, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05958342
- Sponsor's protocol ID
- STUDY23040043
- Other IDs
- HT9426-26-3-E002
- Acronym
- CAVALIER
- Status last verified
- Oct 2026
- First submitted
- 14 Jul 2023
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data may be shared with the funding agency as well as other researchers upon request to the Principal Investigator
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAlcium and VAsopressin Following Injury Early Resuscitation (CAVALIER) Trial
- ClinicalTrials.gov ID
- NCT05958342
- Acronym / sponsor ID
- CAVALIER / STUDY23040043
- Conditions
- Trauma, Hemorrhage
- Keywords
- hemorrhagic shock, trauma, calcium gluconate, vasopressin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,050 participants (estimated)
- Lead sponsor
- Jason SperryUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 30 Jun 2024 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 24 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- In-Hospital phase: permuted block design
| Arm | Type | Receives |
|---|---|---|
| Prehospital Intervention Arm | Experimental | Drug: Calcium Gluconate1 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 |
| Prehospital Control Arm | Placebo comparator | Drug: saline placeboIdentical 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 |
| Early In-Hospital Intervention Arm | Experimental | Drug: Vasopressin4-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. |
| Early In-Hospital Control Arm | Placebo comparator | Drug: saline placebovolume matched saline bolus followed by volume matched normal saline placebo infusion for eight hours initiated within approximately two hours of enrollment |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
- Injured patients at a participating CAVALIER trial site at risk of hemorrhagic shock who meet the following criteria:
Key exclusion criteria (22 listed)
- Prehospital Phase
- Wearing NO CAVALIER opt-out bracelet
- Age > 90 or < 18 years of age
- Isolated fall from standing injury mechanism
- Known prisoner
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcium Gluconate1 gram calcium gluconate provided via intravenous or intraosseous access over approximately 2-5 minutes | Drug | Prehospital Intervention Arm |
| Vasopressin4 unit vasopressin bolus followed by vasopressin infusion at 0.04 U/min for eight hours | Drug | Early In-Hospital Intervention Arm |
| saline placebosaline placebo volume matched to prehospital or in hospital phase | Drug | Early In-Hospital Control Arm, Prehospital Control Arm |
Primary outcome
Number of participants with 30-day mortality
Time frame: from randomization to death or 30 days, whichever comes first
all cause mortality within 30 days
15 secondary outcomes
Number of participants with 6-hour mortality
Time frame: from randomization to death or 6 hours, whichever comes first
Number of participants with 24-hour mortality
Time frame: from randomization to death or 24 hours, whichever comes first
Number of participants with In-hospital mortality
Time frame: In hospital mortality from time of randomization to death or 30 days, whichever comes first
Number of participants with Death from hemorrhage
Time frame: from randomization to death or 30 days, whichever comes first
Number of participants with Death from brain injury
Time frame: from randomization to death or 30 days, whichever comes first
Blood and blood component transfusion requirements in the initial 6 hours
Time frame: from randomization to 6 hours
Blood and blood component transfusion requirements in the initial 24 hours
Time frame: from randomization to 24 hours
Incidence of Multiple Organ Failure (MOF)
Time frame: Scores determined daily until up to Day 7 or ICU discharge, whichever comes first
Incidence of nosocomial infection
Time frame: from randomization to death or 30 days
Time to hemostasis
Time frame: hospital arrival to 4 hours
Incidence of coagulopathy by thromboelastography (TEG)
Time frame: within 4 hours of arrival plus or minus 12
Incidence of coagulopathy by thromboelastography (TEG)
Time frame: within 24 hours of arrival plus or minus 12
ICU free days
Time frame: From hospital arrival to death or 30 days
Hospital free days
Time frame: From hospital arrival to death or 30 days
Ionized calcium measurements
Time frame: Measured in the first 60 minutes (+/- 3 hours), when feasible, during early stage resuscitation in emergency department or operating room
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified data may be shared with the funding agency as well as other researchers upon request to the Principal Investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jason Sperry, MD principal investigator
University of Pittsburgh
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Calcium Gluconate and Vasopressin in people with Trauma and Hemorrhage, run by Jason Sperry at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jason Sperry, MD (4128028270, sperryjl@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with 30-day mortality (time frame: from randomization to death or 30 days, whichever comes first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.