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去氨加压素用于预防接受侵入性操作的血小板减少重症患者出血:一项随机、双盲、安慰剂对照的可行性试验。

Desmopressin for prevention of bleeding for thrombocytopenic, critically ill patients undergoing invasive procedures: A randomised, double-blind, placebo-controlled feasibility trial.

作者信息

Desborough Michael J R, Laing Emma, Kounali Daphne, Mora Ana, Hodge Renate, Martin Siobhan, Thomas Helen, Hudson Cara, Parsons Joseph, Shah Akshay, Hutton Paula, Parke Tim, Wise Matthew P, Morgan Matthew, McKechnie Stuart, Stanworth Simon J

机构信息

Department of Clinical Haematology Oxford University Hospitals NHS Foundation Trust Oxford UK.

Radcliffe Department of Medicine University of Oxford Oxford UK.

出版信息

EJHaem. 2024 Jun 16;5(4):772-777. doi: 10.1002/jha2.955. eCollection 2024 Aug.

Abstract

Thrombocytopenic patients have an increased risk of bleeding when undergoing invasive procedures. In a multicentre, phase II, blinded, randomised, controlled feasibility trial, critically ill patients with platelet count 100 × 10/L or less were randomised 1:1 to intravenous desmopressin (0.3 µg/kg) or placebo before an invasive procedure. Forty-three participants (18.8% of those eligible) were recruited, with 41 eligible for analysis. Post-procedure bleeding occurred in one of 22 (4.5%) in the placebo arm and zero of 19 in the desmopressin arm. Despite liberal inclusion criteria, there were significant feasibility challenges recruiting patients in the critical care setting prior to invasive procedures.

摘要

血小板减少症患者在接受侵入性操作时出血风险增加。在一项多中心、II期、盲法、随机、对照可行性试验中,血小板计数为100×10⁹/L或更低的重症患者在侵入性操作前被1:1随机分配接受静脉注射去氨加压素(0.3μg/kg)或安慰剂。招募了43名参与者(占 eligible者的18.8%),其中41名符合分析条件。安慰剂组22名患者中有1名(4.5%)术后出血,去氨加压素组19名患者中无出血。尽管纳入标准宽松,但在侵入性操作前的重症监护环境中招募患者存在重大的可行性挑战。

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