Point of Care Testing for Coagulation Function Versus Standard Laboratory Testing in Pediatric Patients Undergoing Major Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- International Normalized Ratio (INR) on CoaguChek
研究概览
简要总结
The current study proposes to investigate Point of Care Testing (POCT) (Coagcheck®) and compare obtained results versus standard laboratory coagulation parameters prothrombin time (PT) and partial thromboplastin time (PTT). The time difference in obtaining the two results will also be examined. A total of 100 pediatric patients undergoing spinal surgery or cardiopulmonary bypass will be enrolled and consented per protocol. Blood samples will be obtained simultaneously tested on both the standard laboratory apparatus and the Coagcheck® device. If the two results are comparable, this could have immediate clinical application and impact in the operating room as POCT results are available within 2-3 minutes compared to 1-2 hours for standard laboratory samples.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing elective posterior spinal fusion surgery at Nationwide Children's Hospital
- •Parents willing & able to provide informed consent
- •Child able to provide assent (if age appropriate)
排除标准
- •Pre-existing bleeding disorders
- •Any other circumstance which, in the opinion of the investigator, would put the patient at increased risk.
研究组 & 干预措施
Spinal fusion
Patients undergoing a posterior spinal fusion and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.
干预措施: CoaguChek (Device)
Spinal fusion
Patients undergoing a posterior spinal fusion and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.
干预措施: Hospital Laboratory (Other)
Cardiac bypass
Patients undergoing surgery requiring cardiopulmonary bypass and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.
干预措施: CoaguChek (Device)
Cardiac bypass
Patients undergoing surgery requiring cardiopulmonary bypass and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.
干预措施: Hospital Laboratory (Other)
结局指标
主要结局
International Normalized Ratio (INR) on CoaguChek
时间窗: At end of surgery (an average of 2-4 hrs for cardiac bypass and 4-6 hrs. for spinal fusion)
Measuring the blood's ability to clot on a handheld monitor.
International Normalized Ratio (INR) Performed by Hospital Laboratory
时间窗: At end of surgery (an average of 2-4 hrs for cardiac bypass and 4-6 hrs. for spinal fusion)
Measuring the bloods ability to clot by the hospital's reference laboratory.
次要结局
未报告次要终点
研究者
Vidya Raman
Director of Preoperative Assessment Testing
Nationwide Children's Hospital