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临床试验/NCT04785885
NCT04785885Unknown不适用

Assessment of Clinical Onset of IV Heparin in Interventional Cardiology and Cardiac Surgery

Rhode Island Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年3月9日最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
1
主要终点
Activated Clotting Time (ACT)

研究概览

简要总结

The efficiency and promptness of heparin anticoagulation is necessary during the structural heart procedures to minimize time from insertion of cannulae to valve deployment in cardiac surgery. The goal of this study is to determine how rapidly the adequacy of heparin induced anticoagulation occurs using two different point of care activated clotting time technologies (iSTAT and Hemochron).

详细描述

Adequate anticoagulation is achieved in cardiac surgery and interventional cardiology procedures with intravenous (IV) administration of unfractionated heparin. The Activated clotting time (ACT) is routinely measured to assess adequacy of anticoagulation to prevent clotting/thrombotic complications from placement of foreign materials used during cardiac surgery and cardiology procedures. Alternative methods to measure adequacy of anticoagulation such as measurement of Anti-Xa level and Reaction (R) time as assessed by Thromboelastrography (TEG) have also been suggested. However, their use in clinical practice is limited by lack of Point of Care (POC) technology and need for additional expertise to run these tests.

The efficiency and promptness of heparin anticoagulation is necessary during the structural heart procedures to minimize time from insertion of cannulae to valve deployment in cardiac surgery. The time required to prevent major complications is on the order of seconds to minutes. The goal of this study is to determine how rapidly the adequacy of heparin induced anticoagulation occurs using two different point of care ACT technologies (iSTAT and Hemochron). It is hypothesized that anticoagulation can be determined by the iSTAT ACT device 30 seconds after administration of heparin. Measuring heparin effectiveness at 30 or 90 seconds instead of the usual 3-minute time period may allow for earlier cardiac intervention.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult cardiac surgery patients presenting for elective valvular surgery
  • Interventional cardiology patients presenting elective Transcatheter Aortic Valve Replacement (TAVR)

排除标准

  • Preoperative IV heparin administration within 12 hours of surgery
  • Preoperative oral anticoagulant use within 24 hours of surgery
  • Platelet count <120,000U/ml within 24 hours of surgery

结局指标

主要结局

Activated Clotting Time (ACT)

时间窗: Baseline, 30 seconds and 180 seconds after IV heparin administration

Change in point of care activated clotting time (ACT) levels over time after IV heparin administration

次要结局

  • Laboratory-based anticoagulation(Baseline, 30 seconds and 180 seconds after IV heparin administration)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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