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OpenTrials
Completed

NCT Number: NCT03647644

Coagulation Test Changes Associated With Acute Normovolemic Hemodilution in Cardiac Surgery

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.

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Key information

Conditions

Coagulation Disorder Bleeding Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Hemostatic Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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 If clinically indicated, the blood, about 2 units, will be withdrawn from the subject.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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coagulation Laboratory Testing

Diagnostic Test

Standard coagulation testing (Platelet count, Fibrinogen, PT/INR, aPTT), and Thromboelastogram as is routine and per institutional protocol in this population.

Primary outcomes

  1. Change in Platelet count

    Time frame: 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

  2. Change in Fibrinogen

    Time frame: 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.

  3. Change in Prothrombin Time/international normalized ratio (PT/INR)

    Time frame: 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

  4. Change in aPTT

    Time frame: 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.

  5. Change in Thromboelastogram

    Time frame: 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 outcomes

  1. Allogenic Blood Transfusion

    Time frame: 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.

  2. Chest Tube Output

    Time frame: 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.

  3. Re-operation

    Time frame: 24 hours postoperative

    A marker of bleeding in cardiac surgery patients is re-operation. The number of subjects who have re-operation.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 27, 2018
Registry last updated
Jan 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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