Bleeding, Coagulation Disorder
Conditions
Keywords
Cardiac Surgery, Bleeding, Transfusion, Acute Normovolemic Hemodilution
Brief summary
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
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 If clinically indicated, the blood, about 2 units, will be withdrawn from the subject.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.
Interventions
DIAGNOSTIC_TESTCoagulation Laboratory Testing
Standard coagulation testing (Platelet count, Fibrinogen, PT/INR, aPTT), and Thromboelastogram as is routine and per institutional protocol in this population.
Sponsors
Mayo Clinic
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in aPTT | 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. |
| Change in Platelet count | 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 Fibrinogen | 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 Prothrombin Time/international normalized ratio (PT/INR) | 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 Thromboelastogram | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Chest Tube Output | 24 hours postoperative | 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. |
| Re-operation | 24 hours postoperative | A marker of bleeding in cardiac surgery patients is re-operation. The number of subjects who have re-operation. |
| Allogenic Blood Transfusion | 24 hours postoperative | 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. |
Countries
United States
Outcome results
None listed