Optimized Administration of Prothrombin Complex Concentrate (PCC) vs. Standard Transfusion During/After Heart Transplantation - OPSTAHT
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 3
- 主要终点
- Amount of Chest Tube Drainage
研究概览
简要总结
This study is comparing the use of Kcentra vs. standard transfusion in patients undergoing heart transplantation surgery. Half of the patients will receive Kcentra, while the other half will receive fresh frozen plasma.
详细描述
This study will be a randomized (1:1; PCC vs. plasma), open-label trial of hemostatic therapies during heart transplantation. The goal is to enroll 60 patients. Informed consent will be obtained from patients meeting the inclusion and exclusion criteria before the initiation of any study specific procedures. Eligible patients will be randomized to receive either PCC or plasma transfusion. The efficacy of interventions will be evaluated after 30 minutes of protamine administration. After the heart transplantation, thrombocytopenia and/or hypofibrinogenemia may worsen bleeding associated with vitamin K dependent factor deficiencies. Transfusion of platelets and/or cryoprecipitate is permitted if abnormal laboratory values are observed during the rewarming phase of CPB; platelet count <100 x 103/µl, and fibrinogen <200 mg/dl, respectively. Laboratory tests (hematocrit, platelet count, PT, PTT, POC-PT, coagulation factor and inhibitor levels (e.g., factor II, antithrombin), thromboelastometry or thromboelastography, endogenous thrombin generation) will also be obtained at baseline, twice during surgery and at 12-24 hours after 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
- None
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
- •Be willing and able to provide written informed consent.
- •Be at least 18 years of age.
- •Patients with or without ventricular assist device (VAD) undergoing heart transplantation
- •Patients who have been on warfarin for at least 72 hours before cardiopulmonary bypass procedures for heart transplantation.
- •International normalization ration (INR) greater than or equal to 1.5
- •Body temperature greater than 35.0 degrees Celsius.
- •Blood pH greater than 7.2
- •Hemoglobin greater than 7.0 mg/dL.
排除标准
- •Treatment with clopidogrel, prasugrel, or ticagrelor within 5 days prior to study surgery.
- •Known or suspected thrombophilia such as factor V Leiden, hereditary antithrombin III deficiency, heparin-induced thrombocytopenia, disseminated intravascular coagulation.
- •Ischemic or thromboembolic events within 6 weeks of study surgery.
- •Known allergy/anaphylaxis to prothrombin complex concentrate or albumin.
- •Any indication that a potential subject did not comprehend the study restrictions, procedures. or consequences therein an informed consent cannot be convincingly given.
- •Patients on respiratory support including extracorporeal membrane oxygenation (ECMO) .
- •Life expectancy less than 48 hours.
- •Excluded at the discretion of the surgeon based upon surgical safety precautions
研究组 & 干预措施
Kcentra (PCC)
Half of subjects enrolled will be randomized to the Kcentra (PCC) group.
干预措施: Kcentra (Drug)
Frozen Plasma Product, Human
Half of subjects enrolled will be randomized to the standard transfusion group and receive fresh frozen plasma intra-operatively.
干预措施: Frozen Plasma Product, Human (Drug)
结局指标
主要结局
Amount of Chest Tube Drainage
时间窗: From patient out of room time until 24 hours after
Primary outcome: Amount of chest tube output in the first 24 hours
次要结局
- Gastrointestinal complication requiring bowel resection(30 days post-operative or until discharge (whichever comes first))
- Renal Failure(30 days post-operative or until discharge (whichever comes first))
- Red Blood Cell Use(Intraoperatively(from start of first intervention until start of second intervention;after 2nd intervention(post-bypass)until patient out of room time) & Postoperatively(from patient out of room time until 24 hours after;24 hours after until 30 days))
- Mechanical Ventilation(30 days post-operative or until discharge (whichever comes first))
- Stroke or postoperative neurological dysfunction(30 days post-operative or until discharge (whichever comes first))
- Need for circulatory support(30 days post-operative or until discharge (whichever comes first))
- Death(30 days post-operative or until discharge (whichever comes first))
- Plasma Coagulation Factor levels(At baseline, post-bypass/pre-protamine, 30 minutes post-protamine, 12-24 hours post treatment)
- Postoperative INR(30 Minutes post-treatment (after the last dose is completed))
- Blood Product Use(In OR (from OR entry to OR out of room time); postoperatively (patient out of room time) to 24 hours after; from 24 hours after until 30 days post surgery or until discharge (whichever comes first))
- Tracheostomy(30 days post-operative or until discharge (whichever comes first))
- Sepsis(30 days post-operative or until discharge (whichever comes first))
- Peripheral vascular complication(30 days post-operative or until discharge (whichever comes first))
- Thrombin Generation Assay(At baseline, post-bypass/pre-protamine, 30 minutes post-protamine, 12-24 hours post treatment)
- Deep Vein Thrombosis and Pulmonary Thromboembolism(30 days post-operative or until discharge (whichever comes first))
- Surgical Re-exploration(30 days post-operative or until discharge (whichever comes first))