A RANDOMISED CONTROLLED TRIAL OF RED CELL REJUVENATION FOR THE ATTENUATION OF TRANSFUSION ASSOCIATED ORGAN INJURY IN CARDIAC SURGERY: The REDJUVENATE Trial
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Myocardial injury
研究概览
简要总结
The REDJUVENATE Trial proposes to test the hypothesis that postoperative organ injury and inflammation will be less if patients undergoing cardiac surgery who are at risk of large volume blood transfusion (defined as the administration of ≥4 units of red cells) receive rejuvenated washed cells compared to standard care (unwashed aged stored cells).
详细描述
In the REDJUVENATE trial, we propose to establish whether the administration of rejuvenated red cells will reduce inflammation and organ injury in cardiac surgery patients at risk of large volume blood transfusion when compared to standard care. Organ injury and sepsis accounts for the majority of all deaths following cardiac surgery. Once organ injury is established care is primarily supportive and there are no effective treatments. Prevention is therefore a key clinical strategy to prevent death, morbidity and high healthcare costs attributable to these complications. Sepsis and inflammatory organ injury are also the principal causes of death following paediatric cardiac surgery, trauma, non-cardiac complex surgical procedures and in critical care; clinical settings that are also among the principal consumers of blood components. National and international blood management strategies are focused on these patients. Evidence of a clinical benefit attributable to the use of rejuvenated red cells in cardiac surgery patients is therefore likely to translate into more widespread benefits to patients and the National Health Service (NHS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult cardiac surgery patients (≥18 years) undergoing cardiac surgery with cardiopulmonary bypass.
- •Identified as representing a high risk group for massive blood transfusion using a modified risk score. A large volume blood transfusion (LVBT) score of >23 indicates predicted risk of receiving ≥4 units of allogeneic red cells equal to or greater than 55 per cent.
排除标准
- •Emergency or salvage procedure
- •Patients with end stage renal failure defined as an estimated Glomerular Filtration rate (eGFR) <15 mL/min/1.72 m2 calculated from the Modification of Diet in Renal Disease equation, or patients who are on long-term haemodialysis or have undergone renal transplantation.
- •Patients who are prevented from having blood and blood products according to a system of beliefs (e.g. Jehovah's Witnesses).
- •Patients with a pre-existing sepsis or organ injury defined as documented sepsis, acute kidney injury, acute lung injury, myocardial infarction, low cardiac output, liver injury, stroke or pancreatitis within 5 days of surgery.
- •Patients who are participating in another interventional clinical study.
- •Patients requiring irradiated blood.
- •Sickle cell anaemia.
结局指标
主要结局
Myocardial injury
时间窗: baseline to 72 hours postoperatively
measurement of serum troponin
Renal injury
时间窗: baseline to 96 hours postoperatively
measurement of serum creatinine
次要结局
- Urinary neutrophil gelatinase associated lipocalin (NGAL)(baseline to 48 hours postoperatively)
- Sepsis-related Organ Failure Assessment (SOFA) Score(at baseline, 24, 48, 72 and 96 hours postoperatively)
- Arterial serum lactate(24 hours postoperatively until time of resolution of hyperlactataemia)
- Age of each unit of red cells transfused(day of operation)
- Event rates(from date of randomisation through to study completion (3 months))
- Serum creatinine(at 6 weeks postoperatively)
- Recruitment(from date of randomisation through to study completion (3 months))
- eGFR(at 6 weeks postoperatively)
- GI tract injury(at baseline, 24, 48, 72, and 96 hours postoperatively)
- Postoperative blood loss, transfusion of red cell and non-red cell allogenic blood components(day of operation)
- Length of ICU and hospital stay(from date of randomisation through to study completion (3 months))
- Blinding(from date of randomisation through to study completion (3 months))
- Protocol compliance measured through protocol deviations(from date of randomisation through to study completion (3 months))
- Adverse events other than those included in the primary endpoint(from date of randomisation through to study completion (3 months))
- Transfusion reactions(from date of randomisation through to study completion (3 months))
- Lung injury(baseline to 96 hours postoperatively)