SWiFT Canada (Study of Whole Blood in Frontline Trauma): A Pilot Randomized Controlled Trial Assessing Prehospital Whole Blood Versus Component Therapy in Traumatic Hemorrhage
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Proportion of patients enrolled in the study that receive a prehospital transfusion and had full study data collected
研究概览
简要总结
Traumatic injuries affect people of all ages, races, and socioeconomic backgrounds. The Global Burden of Disease study showed that globally in 2019, there were more than 4.4 million deaths due to injury. Furthermore, unintentional injuries are the leading cause of death for people aged 5-29 years worldwide. Uncontrolled bleeding accounts for a significant proportion of these deaths, with approximately 20% occurring in the first 24 hours and 40% occurring within the first 30 days.
Blood transfusion is a life-saving treatment in the management of bleeding patients until bleeding is controlled in hospital, typically delivered through different blood components (red blood cells, plasma and platelets). These components are derived from a whole blood donation and are stored in separate bags (units). There are challenges in carrying separate blood products, such as additional weight in kit bags, and transfusing multiple blood products at the scene can delay transport to hospital.
In Ontario, Ornge Air Ambulance carries red blood cells and plasma to transfuse prehospital. However, a prehospital transfusion strategy has not been established and practice varies across the Canadian setting, and more broadly across the world.
This trial aims to investigate if carrying and transfusing two units of whole blood instead of four units (two red blood cells and two plasma) is feasible and leads to better outcomes for patients.
详细描述
Early blood transfusion improves survival in patients with life-threatening bleeding, but the optimal transfusion strategy in the prehospital setting has yet to be established. Although there is some evidence of benefit with the use of Whole Blood (WB), there have been no RCTs exploring the clinical effectiveness of prehospital administration of WB versus component therapy for bleeding trauma patients in the Canadian setting. The lack of high-quality clinical evidence is recognized in the recent NAC recommendations for the use of WB in Canada.
In collaboration with the SWiFT UK team, the SWiFT Canada study will follow the SWiFT UK protocol but as adopted for the Canadian context. This may allow for future comparisons on effectiveness of the two systems and pilot the ability for two countries with different prehospital systems to be able to follow a similar study protocol for future international RCTs.
Lastly, we have confirmed the support from CBS for the manufacturing and distribution of WB for the duration of the SWiFT Canada trial. Therefore, it is essential for patients, healthcare professionals and blood services that the clinical effectiveness of prehospital WB transfusion is evaluated in a trial before its widespread implementation across CBS in Canada. A national program of WB production would necessitate significant changes in the current manufacturing processes for blood services, in order to provide appropriate support for hospitals. WB production could potentially affect the supply of blood components required to treat other patients, as a unit of WB cannot be used to manufacture other components. However, it could also be argued that early transfusion of WB may reduce the need for further blood component transfusion when patients arrive at hospital, due to earlier control of bleeding. Following the proposed objectives of this pilot RCT would enable us to evaluate all these uncertainties and assist in the planning of a future larger RCT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Patient who has suffered a traumatic injury
- •Attended by a participating Ornge AAS clinical team
- •Requires prehospital blood transfusion to treat major traumatic hemorrhage
排除标准
- •Pediatric (age <16 or transported to pediatric trauma centre [if age unknown])
- •No intravenous or intraosseous access (should be assessed prior to opening box)
- •Knowledge that patient will object to being given blood transfusion for any reasons
- •Blood already administered on-scene, prior to arrival of the participating Ornge AAS
研究组 & 干预措施
Whole Blood (WB)
The use of Whole Blood (WB), leukocytes reduced is indicated for treatment of patients with clinically significant bleeding and have low anti-A and anti-B titres.
Patients will be administered up to 2 units of whole blood administered via either intravenous (IV) or intraosseous (IO) route, according to standard practice at Ornge AAS.
干预措施: Whole Blood (Biological)
Red Blood Cells and Plasma
The control arm will consist of 2 units of RBC and 2 units of plasma (dependent on the standard practice of the Ornge AAS).
RBC and plasma may be administered via either the intravenous (IV) or intraosseous (IO) route, according to standard clinical practice at Ornge AAS.
干预措施: RBC + plasma (Biological)
结局指标
主要结局
Proportion of patients enrolled in the study that receive a prehospital transfusion and had full study data collected
时间窗: through study completion, up to 90 days
Feasibility target: \>90% patients enrolled were able to link prehospital to in-hospital records and \>90% complete data obtained
Number of patients that completed transfusion of at least 1 unit of assigned blood products prior to arrival to receiving lead trauma hospital
时间窗: Enrolment to day 1 after enrolment
Feasibility target: at least 1 unit of blood \[WB, RBC, or plasma\] transfused prior to arrival \>90% of the time
Number of patients that completed transfusion of all assigned blood products at the receiving lead trauma hospital
时间窗: Enrolment to day 1 after enrolment
Feasibility target: \>90% if not already done prior to arrival of hospital
To describe the distribution, redistribution and wastage of WB units produced for the study
时间窗: through study completion, an average of 1 year
Feasibility target: \<10% wastage of WB units produced for the study
Number of patients screened for the study by not randomized due to lack of group O negative WB availability.
时间窗: through study completion, an average of 1 year
次要结局
- Death or Massive Transfusion at 24hrs(through study completion, up to 90 days)
- Critical Care Days(through study completion, up to 90 days)
- Total in-patient stay(through study completion, up to 90 days)
- Hemostatic agents received(through study completion, up to 90 days)
- Blood components received(through study completion, up to 90 days)
- Organ Failure Free Days(through study completion, up to 90 days)
- treatment-emergent adverse events(through study completion, up to 90 days)
- Mortality - 90 days(through study completion, up to 90 days)
- Mortality - 30 days(through study completion, up to 90 days)