Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06820645

Calcium Administration in Life-saving Management During Massive Hemorrhage

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Under the age of 18
  • Pregnant

Treatment and study plan

Calcium Gluconate

Drug

3g IV or IO calcium gluconate.

Other names: Calcium

Control: Placebo

Drug

3g of IV or IO saline placebo.

Other names: saline

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. Total blood product transfused

    Time frame: Duration of MHP, an average of 1 hour

    Number and type of blood products transfused during the MHP

  3. Hemodynamic instability

    Time frame: Duration of MHP, an average of 1 hour

    Mean blood pressure during the MHP

  4. ICU mortality

    Time frame: 30 days

  5. Hospital mortality

    Time frame: 30 days

Study contacts

Contact information is provided by the study sponsor or research team.

Ian Ball, MD

CONTACT

[email protected]

519-685-8500 ext. 71513

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Acronym: CALM

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 11, 2025
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.