高浓度血管性血友病因子对需要血小板输注的危重症患者血小板止血作用的增强——will-plate 随机对照试验方案。

Enhancement of the haemostatic effect of platelets in the presence of high normal concentrations of von Willebrand factor for critically ill patients needing platelet transfusion-a protocol for the will-plate randomised controlled trial.

机构信息

Department for Anesthesia, Prehospital Emergency Medicine and Pain Therapy, University Hospital Basel, Spitalstrasse 21, 4031, Basel, Switzerland.

Intensive Care Unit, University Hospital Basel, Spitalstrasse 21, CH-4031, Basel, Switzerland.

出版信息

Trials. 2023 Jan 20;24(1):47. doi: 10.1186/s13063-022-06876-8.

DOI:10.1186/s13063-022-06876-8

PMID:36670471

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9854010/

Abstract

INTRODUCTION

von Willebrand Factor (vWF) is a key protein mediating platelet adhesion on the surface of damaged endothelia. To the best of our knowledge, no trial exists that investigated the effect of platelet transfusion in combination with the administration of balanced vWF in severe blood loss, despite being widely used in clinical practice. The Basel Will-Plate study will investigate the impact of the timely administration of balanced vWF (1:1 vWF and FVIII) in addition to platelet transfusion on the need for blood and coagulation factor transfusion in patients admitted to the intensive care unit (ICU) who suffer from severe bleeding. The study hypothesis is based on the assumption that adding balanced vWF to platelets will reduce the overall need for transfusion of blood products compared to the transfusion of platelets alone.

METHODS AND ANALYSIS

The Will-Plate study is an investigator-initiated, single-centre, double-blinded randomised controlled clinical trial in 120 critically ill patients needing platelet transfusion. The primary outcome measure will be the number of fresh frozen plasma (FFP) and red blood cell (RBC) transfusions according to groups. Secondary outcome measures include the number of platelet concentrates transfused within the first 48 h after treatment of study medication, quantity of blood loss in the first 48 h after treatment with the study medication, length of stay in ICU and hospital, number of revision surgeries for haemorrhage control, ICU mortality, hospital mortality, 30-day mortality and 1-year mortality. Patients will be followed after 30 days and 1 year for activities of daily living and mortality assessment. The sample size was calculated to detect a 50% reduction in the number of blood products subsequently transfused within 2 days in patients with Wilate® compared to placebo.

ETHICS AND DISSEMINATION

This study has been approved by the Ethics Committee of Northwestern and Central Switzerland and will be conducted in compliance with the protocol, the current version of the Declaration of Helsinki, the ICH-GCP or ISO EN 14155 (as far as applicable) and all national legal and regulatory requirements. The study results will be presented at international conferences and published in a peer-reviewed journal.

TRIALS REGISTRATION

ClinicalTrials.gov NCT04555785.

PROTOCOL VERSION

Clinical Study Protocol Version 2, 01.11.2020. Registered on Sept. 21, 2020.

摘要

简介

血管性血友病因子 (vWF) 是一种介导血小板黏附在受损内皮表面的关键蛋白。据我们所知，尽管在临床实践中广泛应用，但在严重失血的情况下，尚无研究调查血小板输注联合平衡 vWF 给药的效果。巴塞尔 Will-Plate 研究将调查在重症监护病房 (ICU) 因严重出血而入院的患者中，除了血小板输注外，及时给予平衡 vWF（1:1 vWF 和 FVIII）对血液和凝血因子输注的需求的影响。该研究假设基于添加平衡 vWF 到血小板中会减少与单独输注血小板相比，对血液制品输注的总体需求的假设。

方法和分析

Will-Plate 研究是一项由研究者发起的、单中心、双盲随机对照临床试验，纳入 120 名需要血小板输注的危重症患者。主要观察指标为根据组别的新鲜冷冻血浆 (FFP) 和红细胞 (RBC) 输注数量。次要观察指标包括治疗研究药物后 48 小时内输注的血小板浓缩物数量、治疗研究药物后 48 小时内的失血量、ICU 和医院的住院时间、修订手术控制出血的次数、ICU 死亡率、医院死亡率、30 天死亡率和 1 年死亡率。患者将在 30 天和 1 年时进行日常生活活动和死亡率评估。根据使用 Wilate®与安慰剂相比，2 天内随后输注的血液制品数量减少 50%的情况计算了样本量。