Coagulation Test Changes Associated With Acute Normovolemic Hemodilution in Cardiac Surgery

• ClinicalTrials.gov Identifier: NCT03647644
• Recruitment Status: Completed
• First Posted: August 27, 2018
• Last Update Posted: January 7, 2019
• Sponsor: Mayo Clinic
• Information provided by (Responsible Party): Gregory A. Nuttall, M.D., Mayo Clinic

Study Description

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.

Condition or disease	Intervention/treatment
Coagulation Disorder; Bleeding	Diagnostic Test: Coagulation Laboratory Testing

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 If clinically indicated, the blood, about 2 units, will be withdrawn from the subject.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

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 80 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Target Follow-Up Duration: 30 Days
• Official Title: Coagulation Test Changes Associated With Acute Normovolemic Hemodilution in Cardiac Surgery
• Actual Study Start Date: January 31, 2018
• Actual Primary Completion Date: October 11, 2018
• Actual Study Completion Date: October 11, 2018

Groups and Cohorts

Group/Cohort	Intervention/treatment
Acute Normovolemic Hemodilution Group; 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per the discretion of the anesthesiologist, Acute Normovolemic Hemodilution (ANH) blood, about 2 units, will be withdrawn from the patients and stored carefully at room temperature per standard protocol.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; Standard coagulation testing (Platelet count, Fibrinogen, PT/INR, aPTT), and Thromboelastogram as is routine and per institutional protocol in this population.
Control Group; 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; Standard coagulation testing (Platelet count, Fibrinogen, PT/INR, aPTT), and Thromboelastogram as is routine and per institutional protocol in this population.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Subjects are those who are scheduled to undergo elective cardiac surgery. Researchers identify patients who based on our institutional practice would be candidates for ANH which has been shown to reduce bleeding and transfusion in cardiac surgical patients. These patients are consented to participate in the study, and are then followed through their operative day and laboratory results recorded. Patients are not randomized to any treatment arm as part of this study and it is up to the covering anesthesiologist as to whether or not a patient with undergo ANH or not (become a control).

Criteria

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

Contacts and Locations

Locations

United States, Minnesota

Mayo Clinic

Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Mayo Clinic

Investigators

• Principal Investigator: Gregory Nuttall, MD; Mayo Clinic

More Information

Additional Information:

• Responsible Party: Gregory A. Nuttall, M.D., Professor of Anesthesiology, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT03647644
• Other Study ID Numbers: 16-003298
• First Posted: August 27, 2018
• Last Update Posted: January 7, 2019
• Last Verified: January 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gregory A. Nuttall, M.D., Mayo Clinic:

Cardiac Surgery; Bleeding; Transfusion; Acute Normovolemic Hemodilution

Additional relevant MeSH terms:

Hemostatic Disorders; Blood Coagulation Disorders; Hemorrhage; Pathologic Processes; Hematologic Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders