Study to Actively Warm Trauma Patients-2 (STAYWARM-2): A Pilot Feasibility Trial of Chemical Versus Passive Warming Blankets in Massively Bleeding Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 74
- 主要终点
- An increase of 1⁰C at eight hours from the time of blanket placement
研究概览
简要总结
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.
详细描述
Patient screening, recruitment, and enrolment Recruitment will occur in the trauma bay during weekdays between 08:00-20:00hrs by Staff Trauma Team Leaders, with experience in QI initiatives and enrollment of severely bleeding trauma patients in clinical trials. Due to the high acuity of the patient condition, who usually needs multiple emergent interventions, consent will be obtained retrospectively (delayed consenting process). In addition, by seeking the patient's consent for enrollment during a tenuous point in their care, there is a potential of introducing bias, or concerns about coercion into accepting any care related to the initial resuscitation.
As soon as possible, following the randomization and inclusion, the patient (if able to comprehend) or substitute decision maker (SDM), will be approached about the study. They will have their specific warming intervention explained, and will have, at that point, the right to request that their data are withdrawn from the study.
Study personnel will contact the MRP for permission to approach the patient or ask that they introduce the study to the patient. With permission to enter the patient's circle of care, the research coordinator will then approach patients who were randomized and included in the study. The research coordinator will introduce the trial, confirm eligibility and conduct the informed consent discussion. This discussion will include the rationale for the study, the anticipated risks and benefits of participation, and their rights as a study participant (including withdrawal at any time). Capable participants will be offered an opportunity to ask questions and consult with their family and/or their physician before making a decision to continue in the study. If the patient is deemed incapable of providing informed consent for the study, study personnel will approach the SDM and go over the same process to obtain the consent. Patients or SDM will be given an Informed Consent Form to be signed, at this point.
One signed copy of the informed consent will be placed in the participant's medical record, another copy given to the participant and the original kept in the study file with the research coordinator. If the participant does not wish to participate, the reason for declining will be documented.
Patients will be randomized upon activation of the MHP according to a computer-generated allocation sequence using RedCap. If the patient is randomized to receive the intervention, the blood bank technologist will activate the two Ready-Heat® blankets by opening the seal on the packaging. The opened blankets will be attached outside of the first cooler of the MHP with red blood cells units sent to the trauma bay. The cooler will be transported by a porter, taken to the trauma bay and delivered to the trauma team. As this is an open-label trial, only the statistician will remain blinded during the final analysis. Enrollment will occur 08:00-20:00hrs on weekdays with the aim of assessing feasibility of using the blanket when study coordinators are not always available to reinforce temperature monitoring, proper blanket placement, and compliance with keeping the blanket on the patient over the intervention period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Only the statistician will remain blinded during the final analysis.
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Ready-Heat Blanket
Two Ready-Heat 4-panel half blankets applied indirectly (as per manufacturer's directions) with two flannel blankets placed under them.
干预措施: Ready-Heat Chemical Heating Blankets (Other)
Warmed blankets/FAWB
Two warmed blankets (current standard of care) will be applied to the patient.
干预措施: Warmed blankets or FAWB (Other)
结局指标
主要结局
An increase of 1⁰C at eight hours from the time of blanket placement
时间窗: 0-8 hours from trauma bay arrival/blanket application
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.
Adherence to the 2 blankets application in the trauma bay in at least 80% of patients.
时间窗: 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 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.
Adherence to body temperature measurements (in degrees Celsius) 80% of each of the phases of initial care up to 8 hours following admission.
时间窗: 0-8 hours from trauma bay arrival/blanket application
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.
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.
时间窗: 0-8 hours from trauma bay arrival/blanket application
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.
次要结局
- Skin redness and/or burns(0 - 24 hours post-blanket application)
- Coagulation parameter 2: INR(0-24 hours from trauma bay arrival/blanket application)
- Perfusion parameter 2: base deficit(0-24 hours from trauma bay arrival/blanket application)
- Blanket placed directly on skin(0-8 hours from trauma bay arrival/blanket application)
- Concurrent warming strategies(0-8 hours from trauma bay arrival/blanket application)
- Coagulation parameter 1: platelet count(0-24 hours from trauma bay arrival/blanket application)
- Perfusion parameter 1: pH(0-24 hours from trauma bay arrival/blanket application)
- Perfusion parameter 3: serum lactate(0-24 hours from trauma bay arrival/blanket application)
- Hemoglobin level(0-24 hours from trauma bay arrival/blanket application)
- Blood product usage(Within 24 hours post-blanket application/admission.)
- Coagulation parameter 3: fibrinogen(0-24 hours from trauma bay arrival/blanket application)