Calcium Administration in Life-saving Management During Massive Hemorrhage (CALM)

February 5, 2025 updated by: Ian Ball, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

81

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Under the age of 18
  • Pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Calcium Receiving
Patients will receive standard care according to the Ontario MHP with calcium gluconate administration after every 4 units of RBCs given during the MHP.
Drug: calcium gluconate
3g IV or IO calcium gluconate.
Other Names:
  • Calcium
Placebo Comparator: Placebo Comparator
Patients will receive standard care according to the Ontario MHP with saline placebo administration after every 4 units of RBCs given during the MHP.
Drug: Control: Placebo
3g of IV or IO saline placebo.
Other Names:
  • saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility
Time Frame: 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.
Through study completion, an estimate of 1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2025

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

January 13, 2025

First Submitted That Met QC Criteria

February 5, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 5, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15231

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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