Hypothermia Clinical Trial
— STAYWARM-2Official title:
Study to Actively Warm Trauma Patients-2 (STAYWARM-2): A Pilot Feasibility Trial of Chemical Versus Passive Warming Blankets in Massively Bleeding Patients
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.
Status | Not yet recruiting |
Enrollment | 74 |
Est. completion date | March 2026 |
Est. primary completion date | March 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Sunnybrook Health Sciences Centre |
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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. — View Citation
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. — View Citation
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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. — View Citation
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* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | An increase of 1°C at eight hours from the time of blanket placement | To evaluate the effectiveness of the Ready-Heat® blanket to increase temperature by at least 1°C 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 | |
Primary | 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). | |
Primary | 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 | |
Primary | 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 | Concurrent warming strategies | Concurrent warming strategies used (i.e.: fluid warmers, FAWB, etc.) within the first eight hours of admission/blanket application in conjunction with or replacement of Ready-Heat® chemical heating blanket. | 0-8 hours from trauma bay arrival/blanket application | |
Secondary | Blood product usage | Number of units of blood products (plasma, red blood cells, platelets, fibrinogen concentrate) transfused within 24 hours of trauma bay arrival | Within 24 hours post-blanket application/admission. | |
Secondary | Coagulation parameter 1: platelet count | platelet count (x10^9) will be recorded on arrival to the trauma bay and at the next time points as per clinician discretion, up to 24 hours following admission. | 0-24 hours from trauma bay arrival/blanket application | |
Secondary | Coagulation parameter 2: INR | International Normalized Ratio (INR) will be recorded on arrival to the trauma bay and at the next time points as per clinician discretion, up to 24 hours following admission. | 0-24 hours from trauma bay arrival/blanket application | |
Secondary | Coagulation parameter 3: fibrinogen | Fibrinogen (g/L) will be recorded on arrival to the trauma bay and at the next time points as per clinician discretion, up to 24 hours following admission. | 0-24 hours from trauma bay arrival/blanket application | |
Secondary | Perfusion parameter 1: pH | pH will be recorded on arrival to the trauma bay and at the next time points as per clinician discretion, up to 24 hours following admission. | 0-24 hours from trauma bay arrival/blanket application | |
Secondary | Perfusion parameter 2: base deficit | Base deficit (mmol/L) will be recorded on arrival to the trauma bay and at the next time points as per clinician discretion, up to 24 hours following admission. | 0-24 hours from trauma bay arrival/blanket application | |
Secondary | Perfusion parameter 3: serum lactate | Serum lactate (mmol/L) will be recorded on arrival to the trauma bay and at the next time points as per clinician discretion, up to 24 hours following admission. | 0-24 hours from trauma bay arrival/blanket application | |
Secondary | Hemoglobin level | Hemoglobin level measured on arrival, and at the next time points collected as per clinician discretion, up to 24 hours following admission. | 0-24 hours from trauma bay arrival/blanket application | |
Secondary | Blanket placed directly on skin | Number of times the Ready-Heat chemical heating blanket(s) are placed on the skin directly (without regular blankets underneath). Safety measure 1. | 0-8 hours from trauma bay arrival/blanket application | |
Secondary | Skin redness and/or burns | Number of times skin redness and/or burns occurs due to blanket application. Safety measure 2. | 0 - 24 hours post-blanket application |
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