Status:

COMPLETED

Study to Actively Warm Trauma Patients

Lead Sponsor:

Sunnybrook Health Sciences Centre

Conditions:

Massive Blood Loss

Hypothermia

Eligibility:

All Genders

Phase:

NA

Brief Summary

This study evaluates the feasibility of using thermal blankets to actively warm massively bleeding trauma patients at Sunnybrook Health Sciences Centre. It is hypothesized that either full thermal bla...

Detailed Description

Hypothermia (core body temperature of \<36˚C), is a strong risk factor for mortality and poor outcomes in trauma patients due to its negative hemostatic, cardiovascular, respiratory, and renal effects...

Eligibility Criteria

Inclusion

  • Any trauma patient requiring activation of the massive hemorrhage protocol (life- threatening bleeding situation requiring mobilization of blood bank, laboratory and clinical resources, and anticipated need for at least 4 units of red blood cells immediately and component therapy) during the hours when research staff are available. Normothermic (core body temperature between 36˚C or greater) will also be included, as core body temperature drops once resuscitation is initiated.
  • Hypothermic patients (temperature ≤ 35˚C) to whom MHP is NOT activated, when Dr. Luis da Luz/trauma fellow is on call as Trauma Team Leader will also be included.

Exclusion

  • Patients known to be pregnant
  • Patients who die in the trauma bay
  • Patients excluded at the discretion of the TTL based on use of the blanket not appearing feasible given the sustained injuries, multiple procedures being conducted in the trauma, or patients who seem to have unsurvivable injuries.
  • Patients admitted during study off-hours.

Key Trial Info

Start Date :

October 5 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 1 2021

Estimated Enrollment :

15 Patients enrolled

Trial Details

Trial ID

NCT04399902

Start Date

October 5 2020

End Date

April 1 2021

Last Update

April 19 2021

Active Locations (1)

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Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada, M4N 3M5