Coagulation Test Changes Associated With Acute Normovolemic Hemodilution in Cardiac Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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 If clinically indicated, the blood, about 2 units, will be withdrawn from the subject.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.

Official Title
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Coagulation Test Changes Associated With Acute Normovolemic Hemodilution in Cardiac Surgery

Conditions
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Coagulation Disorder, Bleeding

Intervention / Treatment
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* Diagnostic Test: Coagulation Laboratory Testing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Undergoing a cardiac surgical procedure utilizing cardiopulmonary bypass Permission to use medical records in research Exclusion Criteria: 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 Pregnant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Acute Normovolemic Hemodilution Group<br>All patients enrolled in the study will undergo a perioperative cardiac surgical anesthetic care plan standardized to the current institutional protocol utilized for intraoperative medication administration. If clinically indicated and appropriate per the discretion of the anesthesiologist, Acute Normovolemic Hemodilution (ANH) blood, about 2 units, will be withdrawn from the patients and stored carefully at room temperature per standard protocol. At the conclusion of cardiopulmonary bypass and after protamine administration, Coagulation Laboratory Testing will be drawn from the patients prior to re-infusing the ANH blood and after the blood has been infused per standard institutional protocol. | Diagnostic Test: Coagulation Laboratory Testing<br>* Standard coagulation testing (Platelet count, Fibrinogen, PT/INR, aPTT), and Thromboelastogram as is routine and per institutional protocol in this population.<br>|
| Control Group<br>All patients enrolled in the study will undergo a perioperative cardiac surgical anesthetic care plan standardized to the current institutional protocol utilized for intraoperative medication administration. In this arm, ANH would be clinically appropriate, however, the anesthesiologist determined they would not have ANH preformed. At the conclusion of cardiopulmonary bypass and after protamine administration, Coagulation Laboratory Testing will be drawn from the patients and again 30 minutes later to mirror the time lapse in the ANH group. | Diagnostic Test: Coagulation Laboratory Testing<br>* Standard coagulation testing (Platelet count, Fibrinogen, PT/INR, aPTT), and Thromboelastogram as is routine and per institutional protocol in this population.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Platelet count | 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 | baseline, 30 minutes after cardiopulmonary bypass | 
| Change in Fibrinogen | Component of blood that aids in coagulation. Also known as a blood coagulation factor. Normal reference range 200-393 mg/dL. | baseline, 30 minutes after cardiopulmonary bypass | 
| Change in Prothrombin Time/international normalized ratio (PT/INR) | 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 | baseline, 30 minutes after cardiopulmonary bypass | 
| Change in aPTT | 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. | baseline, 30 minutes after cardiopulmonary bypass | 
| Change in Thromboelastogram | 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. | baseline, 30 minutes after cardiopulmonary bypass | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Allogenic Blood Transfusion | The amount of Allogenic Blood Transfusion volume required as measured by number of transfused units of red blood cells, platelets, fresh frozen plasma, and cryoprecipitate. | 24 hours postoperative | 
| Chest Tube Output | A marker of bleeding in cardiac surgery patients is chest tube output. The amount of fluid as measured in mL's of blood accumulated in the chest tube collection device in 24 hours. | 24 hours postoperative | 
| Re-operation | A marker of bleeding in cardiac surgery patients is re-operation. The number of subjects who have re-operation. | 24 hours postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac Surgery, Bleeding, Transfusion, Acute Normovolemic Hemodilution