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Calcium Administration in Life-saving Management During Massive Hemorrhage

ConditionsMassive HemorrhageTraumaHypocalcemia
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Under the age of 18

Pregnant

Trial design

Design model

Parallel

Treatments tested in this trial

  • calcium gluconate

    Drug

    3g IV or IO calcium gluconate.

  • Control: Placebo

    Drug

    3g of IV or IO saline placebo.

Treatment groups

81 Participants
are divided into 2 treatment groups
Group A: Calcium ReceivingExperimental treatment 1 intervention
Group B: Placebo ComparatorPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility

Recruitment of patients, adherence to the protocol, and assessment of any protocol violations that occur during the trial.

Time frame
Through study completion, an estimate of 1 year

Secondary outcomes

1

Ionized calcium (iCa)

Change in iCa between first iCa measurement during MHP and first iCa measurement after MHP

Time frame
An estimate of up to 24 hours
2

Total blood product transfused

Number and type of blood products transfused during the MHP

Time frame
Duration of MHP, an average of 1 hour
3

Hemodynamic instability

Mean blood pressure during the MHP

Time frame
Duration of MHP, an average of 1 hour
4

ICU mortality

Time frame
30 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

London Health Sciences Centre

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: