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Not yet recruiting NCT06820645

Calcium Administration in Life-saving Management During Massive Hemorrhage

Phase II / Phase III Interventional Massive Hemorrhage Trauma Hypocalcemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: calcium gluconate, Control: Placebo.
Who it may be relevant to
Registry conditions: Massive Hemorrhage, Trauma, Hypocalcemia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

  • Drug calcium gluconate
    3g IV or IO calcium gluconate.
  • Drug Control: Placebo
    3g of IV or IO saline placebo.

Primary outcome measures

  • Feasibility [Time frame: Through study completion, an estimate of 1 year]
Secondary outcome measures (5)
  • Ionized calcium (iCa) [Time frame: An estimate of up to 24 hours]
  • Total blood product transfused [Time frame: Duration of MHP, an average of 1 hour]
  • Hemodynamic instability [Time frame: Duration of MHP, an average of 1 hour]
  • ICU mortality [Time frame: 30 days]
  • Hospital mortality [Time frame: 30 days]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • Under the age of 18
  • Pregnant

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Other

Study locations

Center list to be confirmed — check the primary protocol.

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 38294820

Identifiers

NCT: NCT06820645 · 15231

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗