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Calcium Administration in Life-saving Management During Massive Hemorrhage

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

Status
Not yet recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06820645
Acronym
CALM
Enrollment
81
Registered
2025-02-11
Start date
2025-05-01
Completion date
2026-05-31
Last updated
2025-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Massive Hemorrhage, Trauma, Hypocalcemia

Keywords

Calcium, Massive Hemorrhage Protocol

Brief 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 received during the MHP.

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.

Interventions

3g IV or IO calcium gluconate.

3g of IV or IO saline placebo.

Sponsors

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Under the age of 18 * Pregnant

Design outcomes

Primary

MeasureTime frameDescription
FeasibilityThrough study completion, an estimate of 1 yearRecruitment of patients, adherence to the protocol, and assessment of any protocol violations that occur during the trial.

Secondary

MeasureTime frameDescription
Total blood product transfusedDuration of MHP, an average of 1 hourNumber and type of blood products transfused during the MHP
Hemodynamic instabilityDuration of MHP, an average of 1 hourMean blood pressure during the MHP
ICU mortality30 days
Hospital mortality30 days
Ionized calcium (iCa)An estimate of up to 24 hoursChange in iCa between first iCa measurement during MHP and first iCa measurement after MHP

Contacts

Primary ContactIan Ball, MD
Ian.Ball@lhsc.on.ca519-685-8500

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026