Clinical Performance of the Investigational GEM Hemochron® 100 in Populations Ages 18 Years and Older
试验速览
- 阶段
- 不适用
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Hemochron® MCS 7000 Whole Blood Microcoagulation System ACT measurements (time of whole blood coagulation in seconds) are clinically equivalent to those of the Hemochron Signature Elite® Whole Blood Microcoagulation System
研究概览
简要总结
This study is designed to evaluate and verify the clinical accuracy of the Hemochron® MCS 7000 Whole Blood Microcoagulation System; a point-of-care, whole blood Activated Clotting Time (ACT) measurement in comparison with the Hemochron Signature Elite® Whole Blood Microcoagulation System; a 510(k) cleared predicate device. This is a multi-center, prospective method comparison, with data to be analyzed separately from each site as well as combined for all sites.
详细描述
The study will be performed in the clinical setting by trained professional operators.
Group 1: Whole Blood Coagulation Test 1, GEM Hemochron® 100
Group 2: Whole Blood Coagulation Test 2, Hemochron® Signature Elite® 7000 Whole Blood Microcoagulation System
Ex-vivo whole blood samples destined for discard after all medically directed tests are complete will be used from heparinized patients undergoing standard of care interventional procedures in different clinical settings. These include, but are not limited to, the cardiovascular operating room (CVOR), cardiac catheterization lab, surgical intensive care unit (SICU), the electrophysiology (EP) lab, and in extracorporeal membrane oxygenation (ECMO) applications.
A distribution of ACT values is necessary to evaluate clinical accuracy. The target number of subjects for each site is 100.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Therapeutic Group
- •Patients meeting all of the following criteria will be considered for entry into the study:
- •Males and females 18 years or older.
- •Patients scheduled for elective or urgent procedures requiring anticoagulation with UFH.
- •Patients requiring heparin anticoagulant therapy for any approved indication and being managed and monitored with the ACT test.
排除标准
- •The following criteria define the population of subjects who will not be accepted in the study:
- •The subject develops a significant, unexpected, concurrent illness or adverse event before the first whole blood sample is drawn.
- •The subject with a hematocrit of less than 20% or greater than 55% since these samples are not recommended for testing due to optical densities outside of the Hemochron instrument levels of detection.
结局指标
主要结局
Hemochron® MCS 7000 Whole Blood Microcoagulation System ACT measurements (time of whole blood coagulation in seconds) are clinically equivalent to those of the Hemochron Signature Elite® Whole Blood Microcoagulation System
时间窗: Therapeutic: 1 day; Normal: 1 day (duration of a single venous blood collection)
Demonstrate that the Hemochron® MCS 7000 Whole Blood Microcoagulation System Activated Clotting Time (ACT) measurements (time of whole blood coagulation in seconds) are clinically equivalent to those of the Hemochron Signature Elite® Whole Blood Microcoagulation System; a 510(k) cleared predicate device
次要结局
未报告次要终点