Coagulation Test Changes Associated With Acute Normovolemic Hemodilution in Cardiac Surgery

Mayo Clinic

Status: Completed

Conditions: Coagulation Disorder; Bleeding

Treatments: Diagnostic Test: Coagulation Laboratory Testing

Study type: Observational

Funder types: Other

Identifiers

NCT03647644

16-003298

Details and patient eligibility

About

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.

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 If clinically indicated, the blood, about 2 units, will be withdrawn from the subject.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

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

80 participants in 2 patient groups

Acute Normovolemic Hemodilution Group

Description:

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per the discretion of the anesthesiologist, Acute Normovolemic Hemodilution (ANH) blood, about 2 units, will be withdrawn from the patients and stored carefully at room temperature per standard protocol.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.

Treatment:

Diagnostic Test: Coagulation Laboratory Testing

Control Group

Description:

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.

Treatment:

Diagnostic Test: Coagulation Laboratory Testing