Clinical trial NCT04399902: Study to Actively Warm Trauma Patients
Official title: STudy to ActivelY WARM Trauma Patients (STAY WARM): A Feasibility Pilot Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Massive Blood Loss
Hypothermia
Keywords: warming blankets
trauma
bleeding
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2020-05-22
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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

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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Was the blanket applied to the patient?
timeFrame: Through study completion, an average of 24 hours
measure: Were patient temperatures recorded?
timeFrame: Through study completion, an average of 24 hours
measure: Did the blanket remain on the patient?
timeFrame: Through study completion, an average of 24 hours
Secondary outcomes:
measure: Was the blanket placed directly on the patients skin?
timeFrame: Through study completion, an average of 24 hours
measure: Cold Discomfort Questionnaire
timeFrame: Up to 2 weeks
measure: Did the patients temperature exceed 38 degrees Celsius?
timeFrame: Through study completion, an average of 24 hours
measure: Did the patient experience any redness and/or burns?
timeFrame: Through study completion, an average of 24 hours
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Luis T da Luz, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: