Coagulation Test Changes Associated With Acute Normovolemic Hemodilution in Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in Prothrombin Time/international normalized ratio (PT/INR)
研究概览
简要总结
The researchers are trying to reduce the need for blood transfusions in subjects having surgery that will involve the use of cardiopulmonary bypass. A unit of whole blood will be removed as part of their standard of care prior to going on cardiopulmonary bypass (CPB). This unit is given back to the subject post CPB. This has been shown to reduce the need for blood transfusion in patients.
详细描述
Subjects will be asked to allow the researchers to take the blood left over from normal standard of care blood draws and do coagulation testing. If clinically indicated, the blood, about 2 units, will be withdrawn from the subject. The researchers will also collect 8 ml (less than two teaspoons) of blood through the catheter that was placed as part of standard of care.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 否
入选标准
- •Undergoing a cardiac surgical procedure utilizing cardiopulmonary bypass
- •Permission to use medical records in research
排除标准
- •Unable to grant informed consent or comply with study procedure
- •Patient refusal of ANH withdrawal.
- •Undergoing emergency open heart-surgery
- •CPB time is expected to be < 30 minutes
- •Less than 18 years of age
结局指标
主要结局
Change in Prothrombin Time/international normalized ratio (PT/INR)
时间窗: baseline, 30 minutes after cardiopulmonary bypass
Laboratory test that measures the clotting ability of blood and is a marker for the amount and functionality of the clotting factors in the blood. Normal reference range 0.9-1.1 seconds
Change in Fibrinogen
时间窗: baseline, 30 minutes after cardiopulmonary bypass
Component of blood that aids in coagulation. Also known as a blood coagulation factor. Normal reference range 200-393 mg/dL.
Change in Platelet count
时间窗: baseline, 30 minutes after cardiopulmonary bypass
A platelet is a tiny piece of cell that is made by breaking off of a large cell in the bone marrow. Platelets are found in the blood and spleen. They help form blood clots to slow or stop bleeding, and to help wounds heal. Also called thrombocyte. Normal platelet count ranges from 150,000 to 450,000 platelets per microliter of blood. Units: 10(9)/L
Change in Thromboelastogram
时间窗: baseline, 30 minutes after cardiopulmonary bypass
Laboratory test that looks at the bloods ability to form a clot and the the strength of the blood clot. It looks at all the components that allow blood to clot as a whole. The visual shape of the test along with objective data provide diagnostic information about normal or abnormal conditions of blood coagulation.
Change in aPTT
时间窗: baseline, 30 minutes after cardiopulmonary bypass
Laboratory test that measures the clotting ability of blood and is a marker for the amount and functionality of the clotting factors in the blood. Normal reference range 25-37 seconds.
次要结局
- Allogenic Blood Transfusion(24 hours postoperative)
- Re-operation(24 hours postoperative)
- Chest Tube Output(24 hours postoperative)
研究者
Gregory A. Nuttall, M.D.
Professor of Anesthesiology
Mayo Clinic