Clinical trial NCT03647644: Coagulation Test Changes Associated With Acute Normovolemic Hemodilution in Cardiac Surgery
Official title: Coagulation Test Changes Associated With Acute Normovolemic Hemodilution in Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coagulation Disorder
Bleeding
Keywords: Cardiac Surgery
Bleeding
Transfusion
Acute Normovolemic Hemodilution
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-08-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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).

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.

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 If clinically indicated, the blood, about 2 units, will be withdrawn from the subject.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

Eligibility 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

Primary outcomes:
measure: Change in Platelet count
timeFrame: baseline, 30 minutes after cardiopulmonary bypass
measure: Change in Fibrinogen
timeFrame: baseline, 30 minutes after cardiopulmonary bypass
measure: Change in Prothrombin Time/international normalized ratio (PT/INR)
timeFrame: baseline, 30 minutes after cardiopulmonary bypass
measure: Change in aPTT
timeFrame: baseline, 30 minutes after cardiopulmonary bypass
measure: Change in Thromboelastogram
timeFrame: baseline, 30 minutes after cardiopulmonary bypass
Secondary outcomes:
measure: Allogenic Blood Transfusion
timeFrame: 24 hours postoperative
measure: Chest Tube Output
timeFrame: 24 hours postoperative
measure: Re-operation
timeFrame: 24 hours postoperative
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Gregory Nuttall, MD
role: PRINCIPAL_INVESTIGATOR
References: