Study to Actively Warm Trauma Patients-2

NCT06322186 | Not Yet Recruiting

• 1 other identifier: STAYWARM-2 Trial
• Study Type: interventional
• Target: 74
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Chemical heating blankets; Thermoregulation; Feasibility; Efficacy

Outcome Measures

Primary Outcomes (4)

• An increase of 1⁰C at eight hours from the time of blanket placement

  To evaluate the effectiveness of the Ready-Heat® blanket to increase temperature by at least 1⁰C at eight hours from the time of blanket placement in the trauma bay in severely injured trauma patients who required massive hemorrhage protocol activation. Temperature will be measured upon arrival to the trauma bay and at 8 hours from arrival to trauma bay/time of blanket application.

  0-8 hours from trauma bay arrival/blanket application

• Adherence to the 2 blankets application in the trauma bay in at least 80% of patients.

  Adherence to the application of the 2 Ready-Heat® blankets in patients enrolled in the intervention arm throughout the trauma bay resuscitation. Research personnel will record whether the 2 blankets were applied remained on the patient in the trauma bay.

  0-90minutes (from trauma bay arrival until the patient leaves the trauma bay to the next phase of care - generally 30 to 90 minutes from arrival).

• Adherence to body temperature measurements (in degrees Celsius) 80% of each of the phases of initial care up to 8 hours following admission.

  Feasibility of body temperature measurement throughout the different phases of care (i.e.: TB, ED, CT scanner suite, OR, IR suite, ICU) within the first eight hours of blanket application. The temperature will be mesured on arrival to the trauma bay, prior to leaving the trauma bay, prior to leaving the CT scanner suite, prior to leaving the ED to the OR or IR, prior to leaving the IR suite, in the OR as per anesthesia standards, on arrival to the ICU, and at 8 hours time point (time point when the blanket will be removed) or the time point when the patient's temperature reaches 37.0 degrees Celsius. Research personnel will request/record temperature measurements at the time of trauma bay arrival and at any subsequent phases of care up to eight hours from blanket application.

  0-8 hours from trauma bay arrival/blanket application

• Adherence to maintain the blankets applied on the patient in 80% of each of the phases of initial care up to 8 hours following admission.

  Feasibility of maintaining at least one blanket applied throughout the different phases of care (i.e.: TB, ED, CT scanner suite, OR, IR suite, ICU). Research personnel will monitor and record whether the 2 blankets remained on the patient throughout the phases of care.

  0-8 hours from trauma bay arrival/blanket application

Secondary Outcomes (11)

• Concurrent warming strategies

  0-8 hours from trauma bay arrival/blanket application

• Blood product usage

  Within 24 hours post-blanket application/admission.

• Coagulation parameter 1: platelet count

  0-24 hours from trauma bay arrival/blanket application

• Coagulation parameter 2: INR

  0-24 hours from trauma bay arrival/blanket application

• Coagulation parameter 3: fibrinogen

  0-24 hours from trauma bay arrival/blanket application

Study Arms (2)

Ready-Heat Blanket

EXPERIMENTAL

Two Ready-Heat 4-panel half blankets applied indirectly (as per manufacturer's directions) with two flannel blankets placed under them.

Other: Ready-Heat Chemical Heating Blankets

Warmed blankets/FAWB

ACTIVE COMPARATOR

Two warmed blankets (current standard of care) will be applied to the patient.

Other: Warmed blankets or FAWB

Interventions

Ready-Heat Chemical Heating Blankets OTHER

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.

Ready-Heat Blanket

Warmed blankets or FAWB OTHER

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

Warmed blankets/FAWB

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than or equal to 16 years
• Requires massive hemorrhage protocol activation in the trauma bay
• Admitted to the trauma bay between 08:00-20:00 on a weekday

You may not qualify if:

• Transferred from another healthcare facility
• Death in the trauma bay prior to randomization
• Arrival to trauma bay with ongoing CPR
• Patients with penetrating head injury with Glasgow Coma Scale of 3 and loss of brain matter through the wound

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Related Publications (14)

• Reynolds BR, Forsythe RM, Harbrecht BG, Cuschieri J, Minei JP, Maier RV, Moore EE, Billiar EE, Peitzman AB, Sperry JL; Inflammation and Host Response to Injury Investigators. Hypothermia in massive transfusion: have we been paying enough attention to it? J Trauma Acute Care Surg. 2012 Aug;73(2):486-91.

  PMID: 23019675 BACKGROUND

• Dirkmann D, Hanke AA, Gorlinger K, Peters J. Hypothermia and acidosis synergistically impair coagulation in human whole blood. Anesth Analg. 2008 Jun;106(6):1627-32. doi: 10.1213/ane.0b013e31817340ad.

  PMID: 18499589 BACKGROUND

• Lester ELW, Fox EE, Holcomb JB, Brasel KJ, Bulger EM, Cohen MJ, Cotton BA, Fabian TC, Kerby JD, O'Keefe T, Rizoli SB, Scalea TM, Schreiber MA, Inaba K; PROPPR study group. The impact of hypothermia on outcomes in massively transfused patients. J Trauma Acute Care Surg. 2019 Mar;86(3):458-463. doi: 10.1097/TA.0000000000002144.

  PMID: 30444856 BACKGROUND

• Perlman R, Callum J, Laflamme C, Tien H, Nascimento B, Beckett A, Alam A. A recommended early goal-directed management guideline for the prevention of hypothermia-related transfusion, morbidity, and mortality in severely injured trauma patients. Crit Care. 2016 Apr 20;20(1):107. doi: 10.1186/s13054-016-1271-z.

  PMID: 27095272 BACKGROUND

• Rajagopalan S, Mascha E, Na J, Sessler DI. The effects of mild perioperative hypothermia on blood loss and transfusion requirement. Anesthesiology. 2008 Jan;108(1):71-7. doi: 10.1097/01.anes.0000296719.73450.52.

  PMID: 18156884 BACKGROUND

• Frank SM, Fleisher LA, Breslow MJ, Higgins MS, Olson KF, Kelly S, Beattie C. Perioperative maintenance of normothermia reduces the incidence of morbid cardiac events. A randomized clinical trial. JAMA. 1997 Apr 9;277(14):1127-34.

  PMID: 9087467 BACKGROUND

• Slotman GJ, Jed EH, Burchard KW. Adverse effects of hypothermia in postoperative patients. Am J Surg. 1985 Apr;149(4):495-501. doi: 10.1016/s0002-9610(85)80046-5.

  PMID: 3985289 BACKGROUND

• Phillips D, Bowman J, Zafren K. Successful Field Rewarming of a Patient with Apparent Moderate Hypothermia Using a Hypothermia Wrap and a Chemical Heat Blanket. Wilderness Environ Med. 2019 Jun;30(2):199-202. doi: 10.1016/j.wem.2019.01.001. Epub 2019 Feb 26.

  PMID: 30824366 BACKGROUND

• Bennett BL, Holcomb JB. Battlefield Trauma-Induced Hypothermia: Transitioning the Preferred Method of Casualty Rewarming. Wilderness Environ Med. 2017 Jun;28(2S):S82-S89. doi: 10.1016/j.wem.2017.03.010. Epub 2017 May 5.

  PMID: 28483389 BACKGROUND

• Oden TN, Doruker NC, Korkmaz FD. Compliance of Health Professionals for Prevention of Inadvertent Perioperative Hypothermia in Adult Patients: A Review. AANA J. 2022 Aug;90(4):281-287.

  PMID: 35943754 BACKGROUND

• Munday J, Delaforce A, Forbes G, Keogh S. Barriers and enablers to the implementation of perioperative hypothermia prevention practices from the perspectives of the multidisciplinary team: a qualitative study using the Theoretical Domains Framework. J Multidiscip Healthc. 2019 May 29;12:395-417. doi: 10.2147/JMDH.S209687. eCollection 2019.

  PMID: 31239694 BACKGROUND

• Torossian A, Van Gerven E, Geertsen K, Horn B, Van de Velde M, Raeder J. Active perioperative patient warming using a self-warming blanket (BARRIER EasyWarm) is superior to passive thermal insulation: a multinational, multicenter, randomized trial. J Clin Anesth. 2016 Nov;34:547-54. doi: 10.1016/j.jclinane.2016.06.030. Epub 2016 Jul 17.

  PMID: 27687449 BACKGROUND

• Khayyat H, Callum JL, Hill-Strathy M, Strauss R, Notario L, Nathens A, da Luz L. Compliance with the massive hemorrhage protocol in trauma: a retrospective quality review. Can J Anaesth. 2021 Jan;68(1):156-158. doi: 10.1007/s12630-020-01806-1. Epub 2020 Sep 16. No abstract available.

  PMID: 32936441 BACKGROUND

• Callum JL, Yeh CH, Petrosoniak A, McVey MJ, Cope S, Thompson T, Chin V, Karkouti K, Nathens AB, Murto K, Beno S, Pendergrast J, McDonald A, MacDonald R, Adhikari NKJ, Alam A, Arnold D, Barratt L, Beckett A, Brenneman S, Chaudhry HR, Collins A, Harvey M, Lampron J, Margarido C, McFarlan A, Nascimento B, Owens W, Pai M, Rizoli S, Ruijs T, Skeate R, Skelton T, Sholzberg M, Syer K, Viveiros JL, Theriault J, Tinmouth A, Van Heest R, White S, Zeller M, Pavenski K. A regional massive hemorrhage protocol developed through a modified Delphi technique. CMAJ Open. 2019 Sep 3;7(3):E546-E561. doi: 10.9778/cmajo.20190042. Print 2019 Jul-Sep.

  PMID: 31484650 BACKGROUND

Related Links

• Ready-Heat Blanket Product Website

MeSH Terms

Conditions

Accidental Injuries; Hypothermia

Condition Hierarchy (Ancestors)

Wounds and Injuries; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Luis Da Luz, MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jane Yang

CONTACT

416-480-6100; jane.yang@sunnybrook.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Only the statistician will remain blinded during the final analysis.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Eligible patients will be randomized 1:1 to receive either the experimental or control arm. Experimental arm: 2 Ready-Heat 4-panel blankets Control arm: standard of care (use of warmed blankets and forced air warmed blanket \[FAWB\])

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: March 20, 2024
• Study Start: March 1, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: March 20, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share