protocolSection identificationModule nctId: NCT06322186, orgStudyIdInfo id: STAYWARM-2 Trial, briefTitle: Study to Actively Warm Trauma Patients-2, acronym: STAYWARM-2, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Sunnybrook Health Sciences Centre, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Trauma Injury, conditions: Hypothermia, conditions: Massive Hemorrhage, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 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 \[FAWB\]), primaryPurpose: OTHER, maskingInfo masking: SINGLE, maskingDescription: Only the statistician will remain blinded during the final analysis., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 74, type: ESTIMATED, armsInterventionsModule interventions name: Ready-Heat Chemical Heating Blankets, interventions name: Warmed blankets or FAWB, outcomesModule primaryOutcomes measure: An increase of 1⁰C at eight hours from the time of blanket placement, primaryOutcomes measure: Adherence to the 2 blankets application in the trauma bay in at least 80% of patients., primaryOutcomes measure: Adherence to body temperature measurements (in degrees Celsius) 80% of each of the phases of initial care up to 8 hours following admission., primaryOutcomes measure: 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., secondaryOutcomes measure: Concurrent warming strategies, secondaryOutcomes measure: Blood product usage, secondaryOutcomes measure: Coagulation parameter 1: platelet count, secondaryOutcomes measure: Coagulation parameter 2: INR, secondaryOutcomes measure: Coagulation parameter 3: fibrinogen, secondaryOutcomes measure: Perfusion parameter 1: pH, secondaryOutcomes measure: Perfusion parameter 2: base deficit, secondaryOutcomes measure: Perfusion parameter 3: serum lactate, secondaryOutcomes measure: Hemoglobin level, secondaryOutcomes measure: Blanket placed directly on skin, secondaryOutcomes measure: Skin redness and/or burns, eligibilityModule sex: ALL, minimumAge: 16 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-08-21, uploadDate: 2024-02-21T15:24, filename: Prot_SAP_000.pdf, size: 1303584, hasResults: False