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Why does a point of care guided transfusion algorithm not improve blood loss and transfusion practice in patients undergoing high-risk cardiac surgery? A prospective randomized controlled pilot study

机译:为什么在接受高风险心脏手术的患者中,采用现场护理指导输血算法不能改善失血和输血实践?前瞻性随机对照试验研究

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Adult cardiac surgery is often complicated by elevated blood losses that account for elevated transfusion requirements. Perioperative bleeding and transfusion of blood products are major risk factors for morbidity and mortality. Timely diagnostic and goal-directed therapies aim at the reduction of bleeding and need for allogeneic transfusions. Single-centre, prospective, randomized trial assessing blood loss and transfusion requirements of 26 adult patients undergoing elective cardiac surgery at high risk for perioperative bleeding. Primary endpoint was blood loss at 24?h postoperatively. Random assignment to intra- and postoperative haemostatic management following either an algorithm based on conventional coagulation assays (conventional group: platelet count, aPTT, PT, fibrinogen) or based on point-of-care (PoC-group) monitoring, i.e. activated rotational thromboelastometry (ROTEM?) combined with multiple aggregometry (Multiplate?). Differences between groups were analysed using nonparametric tests for independent samples. The study was terminated after interim analysis (n?=?26). Chest tube drainage volume was 360?ml (IQR 229-599?ml) in the conventional group, and 380?ml (IQR 310-590?ml) in the PoC-group (p?=?0.767) after 24?h. Basic patient characteristics, results of PoC coagulation assays, and transfusion requirements of red blood cells and fresh frozen plasma did not differ between groups. Coagulation results were comparable. Platelets were transfused in the PoC group only. Blood loss via chest tube drainage and transfusion amounts were not different comparing PoC- and central lab-driven transfusion algorithms in subjects that underwent high-risk cardiac surgery. Routine PoC coagulation diagnostics do not seem to be beneficial when actual blood loss is low. High risk procedures might not suffice as a sole risk factor for increased blood loss. NCT01402739 , Date of registration July 26, 2011.
机译:成人心脏手术通常会因失血量增加而复杂化,导致输血需求增加。围手术期出血和输血是导致发病和死亡的主要危险因素。及时的诊断和针对性的治疗旨在减少出血和异体输血的需求。一项单中心,前瞻性,随机试验,评估了接受择期心脏手术的26名成年围手术期出血高风险患者的失血量和输血需求。主要终点是术后24小时失血。根据常规凝血测定(常规组:血小板计数,aPTT,PT,纤维蛋白原)的算法或基于即时监测(PoC组)的监测,即激活的旋转血栓弹力测定法,随机分配至术中和术后止血(ROTEM?)与多重凝集法(Multiplate?)结合使用。使用非参数检验对独立样本进行分析,以分析两组之间的差异。中期分析后终止研究(n≥26)。常规组的胸管引流量为360?ml(IQR 229-599?ml),而PoC组的胸管引流量在24?h后为380?ml(IQR 310-590?ml)(p?=?0.767)。各组患者的基本特征,PoC凝血测定结果以及红细胞和新鲜冰冻血浆的输血要求无差异。凝结结果可比。仅在PoC组中输注血小板。在接受高风险心脏手术的受试者中,通过PoC和中央实验室驱动的输血算法比较,通过胸管引流和输血量造成的失血没有差异。当实际失血量较低时,常规的PoC凝血诊断似乎并不有益。高风险的程序可能不足以作为失血增加的唯一风险因素。 NCT01402739,注册日期:2011年7月26日。

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