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Massive HemorrhagePhase 2/3CALMNCT06820645

Calcium Administration in Life-saving Management During Massive Hemorrhage

A Phase 2/3 study testing calcium gluconate in people with Massive Hemorrhage and Trauma, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study evaluates the feasibility of conducting a larger study on the impact of treating massive hemorrhage with calcium in trauma patients. Patients undergoing the Massive Hemorrhage Protocol (MHP) will be randomly assigned to receive either calcium gluconate or placebo drug after every 4 packs of units of RBCs… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Massive Hemorrhage, Trauma, Hypocalcemia
What is being tested?
calcium gluconate
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
81 participants
Where
No sites listed yet
Study dates
1 May 2025to May 2026
Phase
Phase 2/3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult trauma patients undergoing the MHP at Victoria Hospital, London, Ontario

Who cannot join

  • Under the age of 18
  • Pregnant

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Ian Ball, MD contact

519-685-8500 ext. 71513

Ian.Ball@lhsc.on.ca

About this study

Official title: CALM: Calcium Administration in Life-saving Management of Trauma Patients Undergoing Massive Hemorrhage Protocol: a Single Centre Feasibility Study

This study evaluates the feasibility of conducting a larger study on the impact of treating massive hemorrhage with calcium in trauma patients. Patients undergoing the Massive Hemorrhage Protocol (MHP) will be randomly assigned to receive either calcium gluconate or placebo drug after every 4 packs of units of RBCs received during the MHP.

Read the detailed description

The treatment of hemorrhage with blood products has been well studied, however very little literature exists on the administration of specific electrolytes such as calcium. Citrate is added to blood products to prevent coagulation by chelating free calcium. This process reduces serum calcium and can lead to hypocalcemia, especially in trauma patients who have altered metabolism, hypovolemia, and receive large quantities of blood products. The majority of trauma patients have hypocalcemia upon arrival at the hospital. Serum hypocalcemia in trauma patients matters because calcium is crucial for bleeding control due to its contributions to platelet function, coagulation, and vasoconstriction. Calcium is also essential for other physiological functions during trauma, such as heart and smooth muscle contractility. It is likely due to these key roles that the literature demonstrates hypocalcemia's association with increased mortality, bleeding, blood transfusion requirements, and coagulopathy.

The primary objective of our proposed trial is to assess the feasibility of conducting an interventional calcium trial on patients undergoing the Massive Hemorrhage Protocol (MHP). Feasibility will be evaluated through the recruitment of patients, adherence to protocol, as well as assessment of any protocol violations that occur during the trial. Secondary objectives of our trial include analyzing the effect calcium supplementation has on patient ionized calcium (iCa) level, total blood product transfused, hemodynamic instability, ICU mortality, and hospital mortality.

The investigators will complete a single-centre, double-blinded randomized control feasibility trial. Both trial arms will receive study drug in accordance with Ontario's Massive Hemorrhage Protocol (MHP). After every 4 units of RBCs, the treatment group will receive 3g of calcium gluconate and the control arm will receive saline placebo. Results will be assessed for feasibility to inform the development of a larger trial.

Being tested
calcium gluconate, Control: Placebo
Keywords
Calcium, Massive Hemorrhage Protocol
Medical subject headings
Wounds and Injuries, Hypocalcemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • calcium gluconateDrug

    Also called Calcium

    3g IV or IO calcium gluconate.

  • Control: PlaceboDrug

    Also called saline

    3g of IV or IO saline placebo.

Study groups in NCT06820645
Study groupRoleWhat they receive
Calcium ReceivingExperimentalPatients will receive standard care according to the Ontario MHP with calcium gluconate administration after every 4 units of RBCs given during the MHP.
Receives: Drug: calcium gluconate
Placebo ComparatorPlacebo comparatorPatients will receive standard care according to the Ontario MHP with saline placebo administration after every 4 units of RBCs given during the MHP.
Receives: Drug: Control: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility

    Recruitment of patients, adherence to the protocol, and assessment of any protocol violations that occur during the trial.

    Measured: Through study completion, an estimate of 1 year

Secondary outcomes (5)

  1. Ionized calcium (iCa)

    Change in iCa between first iCa measurement during MHP and first iCa measurement after MHP

    Measured: An estimate of up to 24 hours

  2. Total blood product transfused

    Number and type of blood products transfused during the MHP

    Measured: Duration of MHP, an average of 1 hour

  3. Hemodynamic instability

    Mean blood pressure during the MHP

    Measured: Duration of MHP, an average of 1 hour

  4. ICU mortality

    Measured: 30 days

  5. Hospital mortality

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2025
  2. Study start1 May 2025 (estimated)
  3. Primary completion30 Apr 2026 (estimated)
  4. Study completionMay 2026 (estimated)

Resources

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 2/3
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
81 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06820645
Sponsor's protocol ID
15231
Acronym
CALM
Status last verified
Jan 2025
First submitted
13 Jan 2025
Last updated
11 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Imamoto T, Sawano M. Effect of ionized calcium level on short-term prognosis in severe multiple trauma patients: a clinical study. Trauma Surg Acute Care Open. 2023 Jun 30;8(1):e001083. doi: 10.1136/tsaco-2022-001083. eCollection 2023.

    PubMed 37396952

  • Morotti A, Charidimou A, Phuah CL, Jessel MJ, Schwab K, Ayres AM, Romero JM, Viswanathan A, Gurol ME, Greenberg SM, Anderson CD, Rosand J, Goldstein JN. Association Between Serum Calcium Level and Extent of Bleeding in Patients With Intracerebral Hemorrhage. JAMA Neurol. 2016 Nov 1;73(11):1285-1290. doi: 10.1001/jamaneurol.2016.2252.

    PubMed 27598746

  • Kronstedt 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 35748676

  • Vasudeva M, Mathew JK, Groombridge C, Tee JW, Johnny CS, Maini A, Fitzgerald MC. Hypocalcemia in trauma patients: A systematic review. J Trauma Acute Care Surg. 2021 Feb 1;90(2):396-402. doi: 10.1097/TA.0000000000003027.

    PubMed 33196630

  • Vincent JL, Bredas P, Jankowski S, Kahn RJ. Correction of hypocalcaemia in the critically ill: what is the haemodynamic benefit? Intensive Care Med. 1995 Oct;21(10):838-41. doi: 10.1007/BF01700968.

    PubMed 8557873

  • Giancarelli 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 27083965

  • Bell KT, Salmon CM, Purdy BA, Canfield SG. EVALUATION OF TRANEXAMIC ACID AND CALCIUM CHLORIDE IN MAJOR TRAUMAS IN A PREHOSPITAL SETTING: A NARRATIVE REVIEW. Shock. 2023 Sep 1;60(3):325-332. doi: 10.1097/SHK.0000000000002177. Epub 2023 Jul 12.

    PubMed 37477447

  • Torres CM, Kenzik KM, Saillant NN, Scantling DR, Sanchez SE, Brahmbhatt TS, Dechert TA, Sakran JV. Timing to First Whole Blood Transfusion and Survival Following Severe Hemorrhage in Trauma Patients. JAMA Surg. 2024 Apr 1;159(4):374-381. doi: 10.1001/jamasurg.2023.7178.

    PubMed 38294820

  • Borgman MA, Spinella PC, Perkins JG, Grathwohl KW, Repine T, Beekley AC, Sebesta J, Jenkins D, Wade CE, Holcomb JB. The ratio of blood products transfused affects mortality in patients receiving massive transfusions at a combat support hospital. J Trauma. 2007 Oct;63(4):805-13. doi: 10.1097/TA.0b013e3181271ba3.

    PubMed 18090009

  • Holcomb JB, Tilley BC, Baraniuk S, Fox EE, Wade CE, Podbielski JM, del Junco DJ, Brasel KJ, Bulger EM, Callcut RA, Cohen MJ, Cotton BA, Fabian TC, Inaba K, Kerby JD, Muskat P, O'Keeffe T, Rizoli S, Robinson BR, Scalea TM, Schreiber MA, Stein DM, Weinberg JA, Callum JL, Hess JR, Matijevic N, Miller CN, Pittet JF, Hoyt DB, Pearson GD, Leroux B, van Belle G; PROPPR Study Group. Transfusion of plasma, platelets, and red blood cells in a 1:1:1 vs a 1:1:2 ratio and mortality in patients with severe trauma: the PROPPR randomized clinical trial. JAMA. 2015 Feb 3;313(5):471-82. doi: 10.1001/jama.2015.12.

    PubMed 25647203

  • Saviano A, Perotti C, Zanza C, Longhitano Y, Ojetti V, Franceschi F, Bellou A, Piccioni A, Jannelli E, Ceresa IF, Savioli G. Blood Transfusion for Major Trauma in Emergency Department. Diagnostics (Basel). 2024 Mar 27;14(7):708. doi: 10.3390/diagnostics14070708.

    PubMed 38611621

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing calcium gluconate in people with Massive Hemorrhage and Trauma, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.

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 2 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: opening soon, as of the sponsor's last update on 11 Feb 2025. 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. 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 combined 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.

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?

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 Ian Ball, MD (519-685-8500 ext. 71513, Ian.Ball@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility (time frame: Through study completion, an estimate of 1 year). 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 NCT06820645, which also lists 11 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 11 Feb 2025.

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