A phase III multicentre blinded randomised controlled clinical non-inferiority trial of cryopreserved platelets vs. conventional liquid-stored platelets for the management of post-surgical bleeding.

一项关于冷冻保存血小板与传统液体储存血小板治疗术后出血的 III 期多中心盲法随机对照临床非劣效性试验。

• 批准号: nhmrc : GNT1156641
• 金额: $ 182.56万
• 依托单位: Monash University
• 依托单位国家: 澳大利亚
• 项目类别: Project Grants
• 财政年份: 2019
• 资助国家: 澳大利亚
• 起止时间: 2019-01-01 至 无数据
• 项目状态: 已结题
• 来源: https://researchdata.edu.au/phase-iii-multicentre-surgical-bleeding/1378949
• 关键词: phase; III; multicentre; blinded; randomised

Cryopreservation extends platelet shelf-life from 5 days to 2 years. However, evidence is insufficient for widespread use. Our recent 121-patient pilot trial found encouraging results. We now propose an 808-patient definitive trial in bleeding surgical patients, measuring blood loss, transfusion requirement, complications, and cost. Even if cryopreserved platelets are only equivalent to liquid-stored platelets, their longer shelf-life would justify rapid change in clinical practice worldwide.

冷冻保存可将血小板保存期从5天延长至2年。然而，证据不足以广泛使用。我们最近的121名患者的试点试验发现了令人鼓舞的结果。我们现在提出了一个808例出血手术患者的确定性试验，测量失血量，输血需求，并发症和成本。即使冷冻保存的血小板仅相当于液体储存的血小板，其更长的保质期也将证明全球临床实践的快速变化是合理的。