NCT06820645

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
81

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2025

Shorter than P25 for phase_2

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2025

Completed
29 days until next milestone

First Posted

Study publicly available on registry

February 11, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

February 11, 2025

Status Verified

January 1, 2025

Enrollment Period

12 months

First QC Date

January 13, 2025

Last Update Submit

February 5, 2025

Conditions

Massive HemorrhageTraumaHypocalcemia

Keywords

CalciumMassive Hemorrhage Protocol

Outcome Measures

Primary Outcomes (1)

  • Feasibility

    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 Outcomes (5)

  • Ionized calcium (iCa)

    An estimate of up to 24 hours

  • Total blood product transfused

    Duration of MHP, an average of 1 hour

  • Hemodynamic instability

    Duration of MHP, an average of 1 hour

  • ICU mortality

    30 days

  • Hospital mortality

    30 days

Study Arms (2)

Calcium Receiving

EXPERIMENTAL

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

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

Interventions

calcium gluconateDRUG

3g IV or IO calcium gluconate.

Also known as: Calcium
Calcium Receiving
Control: PlaceboDRUG

3g of IV or IO saline placebo.

Also known as: saline
Placebo Comparator

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Under the age of 18
  • Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (11)

  • 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: 37396952BACKGROUND

  • 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: 27598746BACKGROUND

  • 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: 35748676BACKGROUND

  • 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: 33196630BACKGROUND

  • 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: 8557873BACKGROUND

  • 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: 27083965BACKGROUND

  • 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: 37477447BACKGROUND

  • 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: 38294820BACKGROUND

  • Borgman MA, Spinella PC, Perkins JG, Grathwohl KW, Repine T, Beekley AC, Sebesta J, Jenkins D, Wade CE, Holcomb JB. The ratio of blood products transfused affects mortality in patients receiving massive transfusions at a combat support hospital. J Trauma. 2007 Oct;63(4):805-13. doi: 10.1097/TA.0b013e3181271ba3.

    PMID: 18090009BACKGROUND

  • Holcomb JB, Tilley BC, Baraniuk S, Fox EE, Wade CE, Podbielski JM, del Junco DJ, Brasel KJ, Bulger EM, Callcut RA, Cohen MJ, Cotton BA, Fabian TC, Inaba K, Kerby JD, Muskat P, O'Keeffe T, Rizoli S, Robinson BR, Scalea TM, Schreiber MA, Stein DM, Weinberg JA, Callum JL, Hess JR, Matijevic N, Miller CN, Pittet JF, Hoyt DB, Pearson GD, Leroux B, van Belle G; PROPPR Study Group. Transfusion of plasma, platelets, and red blood cells in a 1:1:1 vs a 1:1:2 ratio and mortality in patients with severe trauma: the PROPPR randomized clinical trial. JAMA. 2015 Feb 3;313(5):471-82. doi: 10.1001/jama.2015.12.

    PMID: 25647203BACKGROUND

  • Saviano A, Perotti C, Zanza C, Longhitano Y, Ojetti V, Franceschi F, Bellou A, Piccioni A, Jannelli E, Ceresa IF, Savioli G. Blood Transfusion for Major Trauma in Emergency Department. Diagnostics (Basel). 2024 Mar 27;14(7):708. doi: 10.3390/diagnostics14070708.

    PMID: 38611621BACKGROUND

MeSH Terms

Conditions

Wounds and InjuriesHypocalcemia

Interventions

Calcium GluconateCalciumSodium Chloride

Condition Hierarchy (Ancestors)

Calcium Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesWater-Electrolyte Imbalance

Intervention Hierarchy (Ancestors)

GluconatesSugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydratesMetals, Alkaline EarthElementsInorganic ChemicalsMetalsBlood Coagulation FactorsBiological FactorsChloridesHydrochloric AcidChlorine CompoundsSodium Compounds

Central Study Contacts

Ian Ball, MD

CONTACT

519-685-8500Ian.Ball@lhsc.on.ca

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Department of Medicine

Study Record Dates

First Submitted

January 13, 2025

First Posted

February 11, 2025

Study Start

May 1, 2025

Primary Completion

April 30, 2026

Study Completion

May 1, 2026

Last Updated

February 11, 2025

Record last verified: 2025-01