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Completed

NCT Number: NCT04399902

Study to Actively Warm Trauma Patients

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 blankets or half thermal blankets will be a feasible intervention to implement for the care of massively bleeding trauma patients.

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Key information

Conditions

Massive Blood Loss Body Temperature Changes Hemorrhage Hypothermia Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Wounds and Injuries

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

About this study

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. Current evidence has reported that massively bleeding hypothermic trauma patients have higher odds of mortality in the first 24 hours of hospital admission, increased length of stay, and increased need for transfusion. Standard hospital blankets are used to passively warm patients through resuscitation and treatment until arrival to the ICU. Interventions such as active heating through thermal blankets should be considered to prevent and treat hypothermia upon arrival of patients than standard warmed hospital blankets to prevent deleterious outcomes in this population.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Thermal Blanket

Device

Ready-Heat 6-Panel Blanket (Military style, manufactured by Techtrade LLC). The 6-panel military-style blanket (86cm x 152 cm, 1.13kg) warms to 40˚C in approximately 15-20 minutes and maintains this temperature for 10 hours.

Primary outcomes

  1. Was the blanket applied to the patient?

    Time frame: Through study completion, an average of 24 hours

    Binary indication of whether or not the blanket is applied to the patient

  2. Were patient temperatures recorded?

    Time frame: Through study completion, an average of 24 hours

    At least 2 temperature recordings (1 in the trauma bay and 1 in the next phase of care - CT scanner suite, angioembolozation suite, emergency department [ED], or operating room), or preferentially, at the final phase of care usually the ICU or ED

  3. Did the blanket remain on the patient?

    Time frame: Through study completion, an average of 24 hours

    Binary indication of whether or not the blanket is kept on the patient in each phase of care until arrival to ICU (1, 2, 3, 4, 5, and 6-hours post initial application of the blanket)

Secondary outcomes

  1. Was the blanket placed directly on the patients skin?

    Time frame: Through study completion, an average of 24 hours

    Number of times blanket is placed directly on the skin

  2. Cold Discomfort Questionnaire

    Time frame: Up to 2 weeks

    Assess cold discomfort of the patient during resuscitation (min value=0 [warm], max value=10 [unbearably cold])

  3. Did the patients temperature exceed 38 degrees Celsius?

    Time frame: Through study completion, an average of 24 hours

    Binary outcome of whether patient temperature exceeded 38 degrees Celsius throughout phases of care

  4. Did the patient experience any redness and/or burns?

    Time frame: Through study completion, an average of 24 hours

    Number of times redness and/or burns are reported by the patient and/or treating clinician

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Registry information

Official study title

STudy to ActivelY WARM Trauma Patients (STAY WARM): A Feasibility Pilot Evaluation

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 22, 2020
Registry last updated
Apr 19, 2021

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.

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