Coagulation Test Changes Associated With Acute Normovolemic Hemodilution in Cardiac Surgery

Bleeding Clinical Trial

Official title:

Coagulation Test Changes Associated With Acute Normovolemic Hemodilution in Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03647644
• Other study ID #: 16-003298
• Status: Completed
• Start date: January 31, 2018
• Est. completion date: October 11, 2018

Study information

• Verified date: January 2019
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 If clinically indicated, the blood, about 2 units, will be withdrawn from the subject.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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 11, 2018
• Est. primary completion date: October 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bleeding
• Blood Coagulation Disorders
• Coagulation Disorder
• Hemorrhage
• Hemostatic Disorders

Intervention

Diagnostic Test:
• Coagulation Laboratory Testing
Standard coagulation testing (Platelet count, Fibrinogen, PT/INR, aPTT), and Thromboelastogram as is routine and per institutional protocol in this population.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	Re-operation	A marker of bleeding in cardiac surgery patients is re-operation. The number of subjects who have re-operation.	24 hours postoperative