HemorrhagePhase 3NCT05953376
Empiric Calcium in Massive Transfusion
A Phase 3 study testing Calcium Gluconate in people with Hemorrhage and Trauma, run by University of California, Irvine.
Trial summary
Calcium helps blood to clot and thereby stop bleeding. Trauma patients who experience large volume blood loss often require blood transfusions and bleeding is the most common cause of death. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhage, Trauma, Hypocalcemia
- What is being tested?
- Calcium Gluconate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2025to Dec 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Trauma patients receiving massive transfusion protocol
Who cannot join
- Pregnancy
- Prisoners
- Known history of hypercalcemia
- Active hyperparathyroidism
- Hemophilia
About this study
Official title: Empiric Calcium Versus Lab Based Treatment in Massive Transfusion Trauma Patients: A Feasibility Randomized Controlled Trial
Calcium helps blood to clot and thereby stop bleeding. Trauma patients who experience large volume blood loss often require blood transfusions and bleeding is the most common cause of death. The purpose of this study is to see if giving intravenous calcium immediately to patients who require large volume blood transfusion will decrease transfusion requirements, vasopressor use and mortality in bleeding trauma patients.
Read the detailed description
Advancements in the area of transfusion and blood product administration have occurred with the use of viscoelastic assays and whole blood. However, as we resuscitate trauma patients with blood products, hypocalcemia is an inadvertent side-effect. Citrate within stored blood binds calcium, causing patients to have hypocalcemia. In addition, outside of transfusion related hypocalcemia there is an independent trauma/inflammation related mechanism for hypocalcemia in the trauma patient. Furthermore, Calcium is a critical component of the coagulation cascade, and therefore a highly important component of hemostatic resuscitation. Hall et al found that patients receiving 13 or more units of PRBCs had a much higher prevalence of severe hypocalcemia and at least one ionized calcium <1.0mmol/L. Kronstedt el al reported an association between hypocalcemia and mortality in trauma patients receiving massive transfusion. Despite evidence that hypocalcemia occurs with transfusion, and evidence that hypocalcemia in patients with hemorrhagic shock may be associated with increased mortality, there are no randomized controlled trials evaluating the administration of calcium in trauma resuscitation. Currently, the Joint Trauma System revised guidelines for damage control resuscitation from 2019 recommend administering 1g of calcium after the first unit of blood transfusion, and an additional 1g after no more than 4 units of blood administration. However, these recommendations are based on small cohort studies or retrospective studies. The purpose of this study is to evaluate the efficacy of early empiric intravenous calcium administration on transfusion requirements, vasopressor use and mortality in hemorrhaging trauma patients with initiation of a massive transfusion.
All trauma patients in which massive transfusion is initiated within 6 hours of arrival will be enrolled. Two study arms will be created, one will receive 2g IV calcium with the initial transfusion and the other will only receive calcium supplementation based on routine ionized calcium levels and/or physician discretion. All critical trauma activations will get a baseline ionized calcium as part of their initial labs.
- Conditions
- Hemorrhage, Trauma, Hypocalcemia, Shock, Hemorrhagic
- Being tested
- Calcium Gluconate
- Medical subject headings
- Hemorrhage, Wounds and Injuries, Hypocalcemia, Shock, Hemorrhagic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium GluconateDrug
Also called Calcium
There will be 2 study arms, one will receive 2g IV calcium with the initial transfusion and the other will only receive calcium supplementation based on routine ionized calcium levels and/or physician discretion.
| Study group | Role | What they receive |
|---|---|---|
| Empiric calcium administration | Experimental | Patients in this arm will receive 2g IV calcium with the initial transfusion Receives: Drug: Calcium Gluconate |
| No empiric calcium administration | No intervention | Patients in this arm will only receive calcium supplementation based on routine ionized calcium levels and/or physician discretion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transfusion requirements
Number of packed red blood cells, whole blood, fresh frozen plasma, platelets and cryo units given
Measured: During first 24 hours of resuscitation
Secondary outcomes (2)
Mortality
30-day mortality or until discharge (whichever is longer)
Measured: 30-day mortality
Vasopressor use
Amount of vasopressor used within the first 24 hours measured in levophed equivalents
Measured: During first 24 hours of resuscitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study startJan 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Why it stopped: Insufficient funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HemorrhageStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffry Nahmias, MD, University of California, Irvine
- Investigators
- Jeffry Nahmias, MD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05953376
- Sponsor's protocol ID
- 3115
- Status last verified
- Mar 2026
- First submitted
- 11 Jul 2023
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hall C, Nagengast AK, Knapp C, Behrens B, Dewey EN, Goodman A, Bommiasamy A, Schreiber M. Massive transfusions and severe hypocalcemia: An opportunity for monitoring and supplementation guidelines. Transfusion. 2021 Jul;61 Suppl 1:S188-S194. doi: 10.1111/trf.16496.
PubMed 34269436Giancarelli A, Birrer KL, Alban RF, Hobbs BP, Liu-DeRyke X. Hypocalcemia in trauma patients receiving massive transfusion. J Surg Res. 2016 May 1;202(1):182-7. doi: 10.1016/j.jss.2015.12.036. Epub 2015 Dec 30.
PubMed 27083965Kronstedt S, Roberts N, Ditzel R, Elder J, Steen A, Thompson K, Anderson J, Siegler J. Hypocalcemia as a predictor of mortality and transfusion. A scoping review of hypocalcemia in trauma and hemostatic resuscitation. Transfusion. 2022 Aug;62 Suppl 1(Suppl 1):S158-S166. doi: 10.1111/trf.16965. Epub 2022 Jun 24.
PubMed 35748676Vettorello M, Altomare M, Spota A, Cioffi SPB, Rossmann M, Mingoli A, Chiara O, Cimbanassi S. Early Hypocalcemia in Severe Trauma: An Independent Risk Factor for Coagulopathy and Massive Transfusion. J Pers Med. 2022 Dec 28;13(1):63. doi: 10.3390/jpm13010063.
PubMed 36675724
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empiric Calcium Versus Lab Based Treatment in Massive Transfusion Trauma Patients: A Feasibility Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05953376
- Acronym / sponsor ID
- 3115
- Conditions
- Hemorrhage, Trauma, Hypocalcemia, Shock, Hemorrhagic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Insufficient funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 20 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.
Calcium helps blood to clot and thereby stop bleeding. Trauma patients who experience large volume blood loss often require blood transfusions and bleeding is the most common cause of death. The purpose of this study is to see if giving intravenous calcium immediately to patients who require large volume blood transfusion will decrease transfusion requirements, vasopressor use and mortality in bleeding trauma patients.
Detailed description
Advancements in the area of transfusion and blood product administration have occurred with the use of viscoelastic assays and whole blood. However, as we resuscitate trauma patients with blood products, hypocalcemia is an inadvertent side-effect. Citrate within stored blood binds calcium, causing patients to have hypocalcemia. In addition, outside of transfusion related hypocalcemia there is an independent trauma/inflammation related mechanism for hypocalcemia in the trauma patient. Furthermore, Calcium is a critical component of the coagulation cascade, and therefore a highly important component of hemostatic resuscitation. Hall et al found that patients receiving 13 or more units of PRBCs had a much higher prevalence of severe hypocalcemia and at least one ionized calcium <1.0mmol/L. Kronstedt el al reported an association between hypocalcemia and mortality in trauma patients receiving massive transfusion. Despite evidence that hypocalcemia occurs with transfusion, and evidence that hypocalcemia in patients with hemorrhagic shock may be associated with increased mortality, there are no randomized controlled trials evaluating the administration of calcium in trauma resuscitation. Currently, the Joint Trauma System revised guidelines for damage control resuscitation from 2019 recommend administering 1g of calcium after the first unit of blood transfusion, and an additional 1g after no more than 4 units of blood administration. However, these recommendations are based on small cohort studies or retrospective studies. The purpose of this study is to evaluate the efficacy of early empiric intravenous calcium administration on transfusion requirements, vasopressor use and mortality in hemorrhaging trauma patients with initiation of a massive transfusion.
All trauma patients in which massive transfusion is initiated within 6 hours of arrival will be enrolled. Two study arms will be created, one will receive 2g IV calcium with the initial transfusion and the other will only receive calcium supplementation based on routine ionized calcium levels and/or physician discretion. All critical trauma activations will get a baseline ionized calcium as part of their initial labs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Empiric calcium administration | Experimental | Drug: Calcium GluconatePatients in this arm will receive 2g IV calcium with the initial transfusion |
| No empiric calcium administration | No intervention | –Patients in this arm will only receive calcium supplementation based on routine ionized calcium levels and/or physician discretion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Trauma patients receiving massive transfusion protocol
Key exclusion criteria (5 listed)
- Pregnancy
- Prisoners
- Known history of hypercalcemia
- Active hyperparathyroidism
- Hemophilia
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 GluconateAlso: CalciumThere will be 2 study arms, one will receive 2g IV calcium with the initial transfusion and the other will only receive calcium supplementation based on routine ionized calcium levels and/or physician discretion. | Drug | Empiric calcium administration |
Primary outcome
Transfusion requirements
Time frame: During first 24 hours of resuscitation
Number of packed red blood cells, whole blood, fresh frozen plasma, platelets and cryo units given
2 secondary outcomes
Mortality
Time frame: 30-day mortality
Vasopressor use
Time frame: During first 24 hours of resuscitation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Background: PubMed 34269436Hall C, Nagengast AK, Knapp C, Behrens B, Dewey EN, Goodman A, Bommiasamy A, Schreiber M. Massive transfusions and severe hypocalcemia: An opportunity for monitoring and supplementation guidelines. Transfusion. 2021 Jul;61 Suppl 1:S188-S194. doi: 10.1111/trf.16496.
- Background: PubMed 27083965Giancarelli A, Birrer KL, Alban RF, Hobbs BP, Liu-DeRyke X. Hypocalcemia in trauma patients receiving massive transfusion. J Surg Res. 2016 May 1;202(1):182-7. doi: 10.1016/j.jss.2015.12.036. Epub 2015 Dec 30.
- Background: PubMed 35748676Kronstedt S, Roberts N, Ditzel R, Elder J, Steen A, Thompson K, Anderson J, Siegler J. Hypocalcemia as a predictor of mortality and transfusion. A scoping review of hypocalcemia in trauma and hemostatic resuscitation. Transfusion. 2022 Aug;62 Suppl 1(Suppl 1):S158-S166. doi: 10.1111/trf.16965. Epub 2022 Jun 24.
- Background: PubMed 36675724Vettorello M, Altomare M, Spota A, Cioffi SPB, Rossmann M, Mingoli A, Chiara O, Cimbanassi S. Early Hypocalcemia in Severe Trauma: An Independent Risk Factor for Coagulopathy and Massive Transfusion. J Pers Med. 2022 Dec 28;13(1):63. doi: 10.3390/jpm13010063.
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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. This study is not recruiting at the moment.
Jeffry Nahmias, MD principal investigator
University of California, Irvine
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Calcium Gluconate in people with Hemorrhage and Trauma, run by University of California, Irvine.
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 1 inclusion and 5 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: withdrawn, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transfusion requirements (time frame: During first 24 hours of resuscitation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05953376, which also lists 4 linked publications.
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 Mar 2026.