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临床试验/NCT06535360
NCT06535360已完成4 期

Improving Efficacy and Safety of Pathogen Inactivation Strategies for Platelet Transfusion in Cardiac Surgical Patients on Cardiopulmonary Bypass

University of Maryland, Baltimore2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
150
试验地点
2
主要终点
Change in Maximum Amplitude (MA) of thromboelastography (TEG)

研究概览

简要总结

This is a prospective randomized clinical trial designed to determine the hemostatic ability of pathogen reduced platelet, when compared to non-pathogen reduced platelets suspended in platelet additive solution.

详细描述

The safety and efficacy of pathogen reduced (PRT) platelets (PLTs) have been investigated in several controlled clinical studies. Most of these clinical studies evaluated the efficacy of PRT PLTs during prophylactic transfusion evaluating post-transfusion platelet count increments, rather than platelet function during bleeding episodes. During massive transfusion events and immediate resuscitation, PLT transfusion is recognized as an important determinant of a positive patient outcome. PLT transfusion is important to control bleeding in patients undergoing cardiac surgery on cardiopulmonary bypass because cardiopulmonary bypass alters platelet function. Thus, transfusion of functional platelets is required to control bleeding post-operatively. In this context, the investigators propose to investigate whether efficient hemostasis associated with platelet transfusion differs with the use of pathogen reduced PRT PLTs compared to non-pathogen reduced PLTs that are suspended in platelet additive solution.

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

入选标准

  • Age > 18 years
  • Preoperative evaluation for risk of transfusion: platelet count < 200,000/mcl, OR anticipated time on cardiopulmonary bypass > 90 min, OR complex cardiac surgery, OR use of preoperative antiplatelet therapy within 3-5 days of surgery.

排除标准

  • Patient that lack the ability to consent
  • Patients with the diagnosis of idiopathic thrombocytopenia purpura,
  • Patient with the diagnosis of heparin-induced thrombocytopenia.

结局指标

主要结局

Change in Maximum Amplitude (MA) of thromboelastography (TEG)

时间窗: within 60 minutes including blood for TEG testing immediately pre transfusion and blood draw post transfusion

ΔMA observed with platelet transfusion (difference in MA measured within an hour post transfusion to MA measured immediately pre-transfusion)

次要结局

  • Chest Tube Drainage(24 hours)
  • Red blood cell units Transfused(Within the first 24 Hrs Following Surgery)
  • Plasma Units Transfused(Within the first 24 Hrs Following Surgery)
  • Platelet Units Transfused(Within the first 24 Hrs Following Surgery)
  • Cryoprecipitate Units Transfused(Within the first 24 Hrs Following Surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Magali Fontaine

Professor of Pathology

University of Maryland, Baltimore

研究点 (2)

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