Study to Actively Warm Trauma Patients-2

Summary

Massively bleeding trauma patients have higher odds of mortality, increased hospital length of stay, and increased need for transfusion if they become hypothermic. Hypothermia is independently associated with mortality in traumatically injured patients due to its negative physiologic effects on hemostasis, cardiorespiratory and renal function.

Current warming strategies increase the logistical difficulty of transferring patients (which is frequent during the initial hours of trauma care) or must be changed at frequent intervals. Prehospital, military, and intraoperative studies have suggested chemical warming blankets as a pragmatic strategy to manage hypothermia. A recent pilot study (manuscript under review) at our institution demonstrated the feasibility of using the Ready-Heat® (TechTrade LLC, Orlando, FL, USA) chemical heating blanket in the initial phases of hospital care in bleeding trauma patients requiring a mass hemorrhage protocol (MHP). These self-warming blankets provide warmth over 8 hours at up to 40 degrees Celsius, carrying the advantage of portability with no continuous electric power requirement. Furthermore, the Ready-Heat blanket may be more effective than current strategies for rewarming patients at high risk of developing hypothermia. STAYWARM-2 will be the first randomized controlled trial performed in-hospital to evaluate a self-warming blanket to address hypothermia in massively bleeding trauma patients within the initial hours of hospital arrival.

This study will help to determine the efficacy and feasibility of using chemical heating blankets for hypothermia in the early hours of hospital care. This has potential to reduce the overall workload of direct care clinicians, freeing them for other patient care duties. Additionally, the intervention may achieve enhanced thermoregulation compared to current strategies, improving patient care and comfort, and avoiding the clinical complications related to hypothermia. Findings from this preliminary study may provide data for a future grant to launch a larger randomized controlled trial in the prehospital/in-hospital trauma setting to optimize the care of patients at risk of developing hypothermia.

Conditions

• Trauma Injury
• Hypothermia
• Massive Hemorrhage

Interventions

OTHER

Ready-Heat Chemical Heating Blankets

Ready-Heat blankets are 4-panel half blankets that generate an oxygen-activated exothermic effect in 8-15 minutes (i.e., no electricity required), providing warmth over 8 hours at up to 40 degrees Celsius.

OTHER

Warmed blankets or FAWB

The current standard of care for hypothermic patients is applying two warmed blankets or forced air warming blankets (FAWB).

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre

  lead OTHER

Principal Investigators

• Luis Da Luz, MD · Sunnybrook Health Sciences Centre

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-03-31

Primary Completion

2026-03-31

Completion

2026-03-31