Calcium Administration in Life-saving Management During Massive Hemorrhage

Phase 2

Not yet recruiting

• Conditions: Trauma; Hypocalcemia; Massive Hemorrhage
• Interventions: Drug: calcium gluconate

• Registration Number: NCT06820645
• Lead Sponsor: London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

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.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-13
• Study First Submitted QC: 2025-02-05
• Last Update Submitted: 2025-02-05
• Study First Posted: 2025-02-11
• Last Update Posted: 2025-02-11
• Study Start: 2025-05-01
• Primary Completion: 2026-04-30
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

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

Exclusion Criteria

• Under the age of 18
• Pregnant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Calcium Receiving	calcium gluconate	Patients will receive standard care according to the Ontario MHP with calcium gluconate administration after every 4 units of RBCs given during the MHP.

Primary Outcome Measures

Name	Time	Method
Feasibility	Through study completion, an estimate of 1 year	Recruitment of patients, adherence to the protocol, and assessment of any protocol violations that occur during the trial.

Secondary Outcome Measures

Name	Time	Method
Total blood product transfused	Duration of MHP, an average of 1 hour	Number and type of blood products transfused during the MHP
ICU mortality	30 days
Ionized calcium (iCa)	An estimate of up to 24 hours	Change in iCa between first iCa measurement during MHP and first iCa measurement after MHP
Hemodynamic instability	Duration of MHP, an average of 1 hour	Mean blood pressure during the MHP
Hospital mortality	30 days