Coagulation Test Changes Associated With Acute Normovolemic Hemodilution in Cardiac Surgery

NCT03647644 | Completed

• 1 other identifier: 16-003298
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Coagulation Disorder; Bleeding

Keywords

Cardiac Surgery; Bleeding; Transfusion; Acute Normovolemic Hemodilution

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Allogenic Blood Transfusion

  24 hours postoperative

• Chest Tube Output

  24 hours postoperative

• Re-operation

  24 hours postoperative

Study Arms (2)

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

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

Interventions

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.

Acute Normovolemic Hemodilution Group; Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• Undergoing a cardiac surgical procedure utilizing cardiopulmonary bypass
• Permission to use medical records in research

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Hemostatic Disorders; Hemorrhage

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gregory Nuttall, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Study Record Dates

• First Submitted: August 23, 2018
• First Posted: August 27, 2018
• Study Start: January 31, 2018
• Primary Completion: October 11, 2018
• Study Completion: October 11, 2018
• Last Updated: January 7, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)