Study to Actively Warm Trauma Patients

NCT04399902 | Completed

• 1 other identifier: STAY WARM Trial
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Massive Blood Loss; Hypothermia

Keywords

warming blankets; trauma; bleeding

Outcome Measures

Primary Outcomes (3)

• Was the blanket applied to the patient?

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

  Through study completion, an average of 24 hours

• Were patient temperatures recorded?

  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

  Through study completion, an average of 24 hours

• Did the blanket remain on the patient?

  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)

  Through study completion, an average of 24 hours

Secondary Outcomes (4)

• Was the blanket placed directly on the patients skin?

  Through study completion, an average of 24 hours

• Cold Discomfort Questionnaire

  Up to 2 weeks

• Did the patients temperature exceed 38 degrees Celsius?

  Through study completion, an average of 24 hours

• Did the patient experience any redness and/or burns?

  Through study completion, an average of 24 hours

Study Arms (1)

Study blanket

EXPERIMENTAL

Two standard warmed hospital blankets will be placed on top of the patient and the study blanket on top of the standard warmed blankets, covering as much of the patient as possible, at the discretion of the care team. At all times, clinicians should ensure that the study blanket does not touch the patient's bare skin.The blanket will remain on the patient through their path of care, and removed from the patient at arrival to the ICU/final phase of care, or if the patient temperature exceeds 38˚C at any point.

Device: Thermal Blanket

Interventions

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.

Study blanket

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Related Publications (1)

• Strauss R, Kron A, Callum J, Armali C, Modi D, Notario L, D'Empaire PP, Tillmann BW, Pannell D, Tien H, Nathens A, Beckett A, da Luz LT. STudy to ActivelY WARM trauma patients (STAY WARM): a pilot study assessing feasibility of self-warming blankets in patients requiring a massive hemorrhage protocol activation. Eur J Trauma Emerg Surg. 2024 Oct;50(5):2289-2294. doi: 10.1007/s00068-024-02612-w. Epub 2024 Aug 7.

  PMID: 39112757 DERIVED

MeSH Terms

Conditions

Hypothermia; Wounds and Injuries; Hemorrhage

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Luis T da Luz, MD, MSc

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: March 30, 2020
• First Posted: May 22, 2020
• Study Start: October 5, 2020
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: April 19, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)