血小板减少症患者中心静脉导管置入术前预防性血小板输注：一项随机对照试验的研究方案
Prophylactic platelet transfusion prior to central venous catheter placement in patients with thrombocytopenia: study protocol for a randomised controlled trial.
作者信息
van de Weerdt Emma K, Biemond Bart J, Zeerleder Sacha S, van Lienden Krijn P, Binnekade Jan M, Vlaar Alexander P J
机构信息
Department of Intensive Care Medicine, Academic Medical Centre, Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands.
Laboratory of Experimental Intensive Care and Anaesthesiology (L.E.I.C.A.), Academic Medical Centre, Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands.
出版信息
Trials. 2018 Feb 20;19(1):127. doi: 10.1186/s13063-018-2480-3.
BACKGROUND
Severe thrombocytopenia should be corrected by prophylactic platelet transfusion prior to central venous catheter (CVC) insertion, according to national and international guidelines. Even though correction is thought to prevent bleeding complications, evidence supporting the routine administration of prophylactic platelets is absent. Furthermore, platelet transfusion bears inherent risk. Since the introduction of ultrasound-guided CVC placement, bleeding complication rates have decreased. The objective of the current trial is, therefore, to demonstrate that omitting prophylactic platelet transfusion prior to CVC placement in severely thrombocytopenic patients is non-inferior compared to prophylactic platelet transfusion.
METHODS/DESIGN: The PACER trial is an investigator-initiated, national, multicentre, single-blinded, randomised controlled, non-inferior, two-arm trial in haematologic and/or intensive care patients with a platelet count of between 10 and 50 × 10/L and an indication for CVC placement. Consecutive patients are randomly assigned to either receive 1 unit of platelet concentrate, or receive no prophylactic platelet transfusion prior to CVC insertion. The primary endpoint is WHO grades 2-4 bleeding. Secondary endpoints are any bleeding complication, costs, length of intensive care and hospital stay and transfusion requirements.
DISCUSSION
This is the first prospective, randomised controlled trial powered to test the hypothesis of whether omitting forgoing platelet transfusion prior to central venous cannulation leads to an equal occurrence of clinical relevant bleeding complications in critically ill and haematologic patients with thrombocytopenia.
TRIAL REGISTRATION
Nederlands Trial Registry, ID: NTR5653 ( http://www.trialregister.nl/trialreg/index.asp ). Registered on 27 January 2016. Currently recruiting. Randomisation commenced on 23 February 2016.
背景
根据国内和国际指南，在插入中心静脉导管（CVC）之前，严重血小板减少症应通过预防性血小板输注来纠正。尽管认为纠正可预防出血并发症，但缺乏支持常规预防性输注血小板的证据。此外，血小板输注存在固有风险。自从引入超声引导下CVC置管以来，出血并发症发生率有所下降。因此，本试验的目的是证明，在严重血小板减少症患者中，CVC置管前不进行预防性血小板输注与预防性血小板输注相比并非不劣。
方法/设计：PACER试验是一项由研究者发起的、全国性、多中心、单盲、随机对照、非劣效性双臂试验，针对血小板计数在10至50×10⁹/L之间且有CVC置管指征的血液学和/或重症监护患者。连续入选的患者被随机分配，要么接受1单位血小板浓缩液，要么在CVC插入前不接受预防性血小板输注。主要终点是世界卫生组织2 - 4级出血。次要终点包括任何出血并发症、成本、重症监护和住院时间以及输血需求。
讨论
这是第一项前瞻性随机对照试验，旨在检验在血小板减少的重症患者和血液学患者中，中心静脉置管前不进行血小板输注是否会导致临床相关出血并发症的发生率相同这一假设。
试验注册
荷兰试验注册中心，编号：NTR5653（http://www.trialregister.nl/trialreg/index.asp）。于2016年1月27日注册。目前正在招募患者。随机分组于2016年2月23日开始。
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