A Phase III Multicentre Blinded Randomised Controlled Clinical Non-inferiority Trial of Cryopreserved Platelets vs. Conventional Liquid-stored Platelets for the Management of Surgical Bleeding
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 388
- 试验地点
- 6
- 主要终点
- Volume of post-surgical bleeding in the first 24 hours
研究概览
简要总结
This trial is a phase III multicentre blinded randomised controlled clinical non-inferiority trial of cryopreserved platelets vs. conventional liquid-stored platelets for the management of surgical bleeding. The aim of the study is to assess the efficacy, safety and cost effectiveness of cryopreserved platelets, compared to conventional liquid-stored platelets, for the management of surgical bleeding. This trial will recruit cardiac surgical patients deemed to be at high risk of surgical bleeding and who may potentially require transfusion of platelets. It is estimated to require 808 high-risk cardiac surgical patients to be recruited, to obtain 202 patients who receive transfused study platelets for surgical bleeding.
详细描述
For logistic reasons and in order to use this scarce resource optimally, liquid-stored platelets are not stored in smaller hospitals, or in deployed military hospitals. Patients in these hospitals therefore currently have limited or no access to platelet transfusion. Cryopreservation of platelets is a promising technology that would allow smaller hospitals to provide platelet transfusions, reduce overall platelet wastage, and possibly produce better patient outcomes through more effective haemostasis.
This is a phase III multicentre blinded randomised controlled clinical non-inferiority trial of cryopreserved platelets vs. conventional liquid-stored platelets for the management of surgical bleeding. The aim of the study is to assess the efficacy, safety and cost effectiveness of cryopreserved platelets, compared to conventional liquid-stored platelets, for the management of surgical bleeding. This trial will recruit cardiac surgical patients deemed to be at high risk of surgical bleeding and who may potentially require transfusion of platelets. It is estimated to require 808 high-risk cardiac surgical patients to be recruited, to obtain 202 patients who receive transfused study platelets for surgical bleeding. The study will recruit patients in Australian tertiary hospitals.The study hypothesis is that cryopreserved platelets will be at least as effective as conventional liquid-stored platelets in the treatment of active bleeding due to surgery.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Platelets will be allocated to participant by unblinded blood bank staff. The platelets will be supplied by the blood bank with an opaque cover that obscures their method of storage (cryopreserved or liquid-stored), but that retain the original Blood Service information for checking.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cardiac surgery patients identified preoperatively as having a high risk of platelet transfusion by either:
- •the ACSePT (Australian Cardiac Surgery Platelet Transfusion (score)) risk prediction tool score ≥1 OR
- •the judgement of the clinicians caring for the patient
- •Written informed consent obtained prior to surgery
排除标准
- •Aged less than 18 years
- •Females of child-bearing age (18- 55 years) who are RhD (Rhesus type D)-negative or whose RhD (Rhesus type D) status is unknown
- •Receipt of platelet transfusion during this hospital admission
- •Deep Vein Thrombosis or Pulmonary Emboli first diagnosed within the preceding 6 months
- •More than one lifetime episode of Deep Vein Thrombosis or Pulmonary Emboli
- •Known inherited or acquired bleeding disorder (e.g. haemophilia, von Willebrand Disease, idiopathic thrombocytopenic purpura, aplastic anaemia, haematological malignancy, chronic liver disease), or any undiagnosed bleeding condition, if (and only if) such a disorder or condition is associated with a significant laboratory abnormality at the time of preoperative screening. i.e.
- •preoperative platelet count <50 000 or
- •INR (International Normalised Ratio) >2 or
- •aPTT (Activated Partial Thromboplastin Time) > 2 x upper limit of normal.
- •Treatment with warfarin, IV heparin or low-molecular weight heparin at "full" therapeutic anticoagulant doses, or other anticoagulant or anti-platelet medications such as factor Xa inhibitors (rivaroxaban, apixaban); factor II inhibitors (dabigatran); adenosine diphosphate receptor inhibitors (clopidogrel, prasugrel, ticagrelor, ticlopidine); glycoprotein IIB/IIIA inhibitors (abciximab, eptifibatide, tirofiban); phosphodiesterase inhibitors (cilostazol); or adenosine reuptake inhibitors (dipyridamole) UNLESS this medication has been discontinued in advance of surgery and its effect allowed to dissipate.
- •Known allergy to dimethylsulphoxide (DMSO)
- •Planned presence of an arterial line and central venous catheter for less than 12 hours postoperatively.
- •Known objection to receipt of human blood components
- •The treating physician believes it is not in the best interest of the patient to be randomised in this trial
- •Previous enrolment during this admission in a clinical trial of a medication or technique thought to influence bleeding, with the exception of any trial of aspirin (i.e. trials involving aspirin are permitted), OR previous enrolment in a clinical trial with a protocol that affects the transfusion of blood products.
- •Previous enrolment in this study
研究组 & 干预措施
Cryopreserved platelets
Platelets that have undergone a process to freeze, store and reconstitute platelets, extending their expiry to 2 years
干预措施: Cryopreserved platelets (Biological)
Liquid-stored platelets
Platelets that have been liquid stored, with an expiry of 5 days.
干预措施: Liquid-stored platelets (Biological)
结局指标
主要结局
Volume of post-surgical bleeding in the first 24 hours
时间窗: First 24 hours from the time of ICU admission
Volume of post-surgical bleeding in the chest drains after cardiac surgery
次要结局
- Composite bleeding outcome using the BARC4 criteria(Up to ICU discharge, death or Day 90, whichever occurs first)
- Total number of units of Packed red blood cells transfused(From operation commencement up to ICU discharge, death or day 90, whichever occurs first)
- Number of units of Packed red blood cells transfused(in the first 24 hours after admission to ICU)
- Occurrence of any one of the following pre-specified potential complications(Up to ICU discharge, death or day 90, whichever occurs first)
- Total volume of post-surgical chest drain bleeding(From ICU admission up to removal of drains, death or day 28, whichever occurs first)