The ZEroPLASmaTrial (ZEPLAST): a Randomized, Controlled Trial on Transfusion Avoidance in High Transfusion-risk Cardiac Surgery Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 119
- 试验地点
- 1
- 主要终点
- Avoidance of allogeneic blood products transfusion
研究概览
简要总结
Prospective, randomized, double blind trial. The rationale of the study is the concept that fresh frozen plasma (FFP) is still largely used in cardiac surgery, despite the fact that prothrombin complexes and fibrinogen are available.The experimental hypothesis is that cardiac surgery patients may be operated with no use of FFP and with a coagulation factors replacement based on fibrinogen and prothrombin complexes (when needed).
Primary endpoint: Transfusion avoidance Secondary endpoints: Transfusion limitation, massive blood transfusion, bleeding.
Study population: high-risk adult cardiac surgery patients Sample size : 2 groups of 60 patients each
详细描述
Study design Randomized, placebo-controlled, double-blinded study Endpoints Primary: Transfusion avoidance of every allogeneic blood product Secondary: Reduction in the number of allogeneic blood products used, reduction in massive blood transfusion events incidence, reduction in postoperative bleeding.
Patient population This study is focused on the role of coagulation factors substitutes in avoiding transfusions. Therefore, the patient population should be composed by patients being at high-risk for transfusions due to bleeding and not to hemodilution. Moreover, bleeding should be primarily due to a coagulation factors deficiency, rather than to other causes (namely, drug-induced platelet dysfunction).
The major determinant of coagulation factors consumption during cardiac operations is the length of CPB. Only patients undergoing operations with a predictable CPB duration > 90 minutes will be admitted. This includes patients undergoing complex cardiac operations (double valve; CABG+valve; ascending aorta; adult congenital patients). Adult congenital patient may be of particular interest, since they usually have a preoperative reduced hepatic coagulation factors synthesis, due to venous stasis and polycythemia.
To avoid the effects of hemodilution in determining transfusional needs, patients with an expected lowest HCT < 23% during CPB will not be admitted to the study. This means excluding patients with a preoperative HCT < 35%, and patients with a small BSA (< 1.7 m2). Hemodilution during CPB will be checked, and in case of a HCT value < 23% the patient will be withdrawn from the study.
Power analysis and sample size
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)
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
- •The patients will be screened according to a modified TRUST1 Transfusion Score. This score attributes 1 point to each of the following conditions:
- •Hb level < 13.5 g/dL
- •Weight < 77 kg
- •Female sex
- •Age > 65 years
- •Non elective surgery
- •Serum creatinine > 1.36 mg/dL
- •Redo operation
- •Non isolated surgery
- •Factors are hemodilution-related factors, and will not be included. Non isolated surgery is mandatory for inclusion. Patients will be included in presence of at least 1 within the remaining 4 risk factors:
- •Age > 65 years
- •Non elective surgery
- •Serum creatinine > 1.36 mg/dL '8Redo operation INCLUSION CRITERIA (patients randomized)
- •Combined cardiac operation with expected CPB duration > 90 minutes
- •At least one additional risk factor within the following: Age > 65 years; Non elective surgery; Serum creatinine > 1.36 mg/dL; Redo operation
排除标准
- •Age < 18 years
- •Patients under thienopyridines
- •Known coagulopathy
- •Known autoimmune disorders
- •Participation in another RCT
- •Emergency operation
- •Baseline HCT < 35%
- •Baseline Antithrombin < 80%
- •BSA < 1.7 m2
- •WITHDRAWAL CRITERION:
- •Lowest HCT on CPB < 23%
- •Transfusions during CPB
- •Patients randomized and not withdrawn will be DOSED with the investigational drugs.
研究组 & 干预措施
Saline solution
干预措施: Saline solution (Drug)
Fibrinogen
干预措施: Fibrinogen (Drug)
Prothrombin complex
干预措施: Prothrombin complex (Drug)
结局指标
主要结局
Avoidance of allogeneic blood products transfusion
时间窗: 30 days
Includes avoidance of packed red cells, FFP, platelet concentrates, cryoprecipitates
次要结局
- Reduction in allogeneic blood products transfusions(30 days)
- Massive blood transfusion(First postoperative 24 hours)
- Bleeding(First postoperative 12 hours)
研究者
Marco Ranucci
Director of Clinical Research in the Department of the Anesthesia and Intensive care
IRCCS Policlinico S. Donato