Biomarker and Thrombogenicity Assessment in Cardiopulmonary Bypass Surgery Utilizing Acute Normovolemic Hemodilution



Status:Recruiting
Healthy:No
Age Range:18 - 85
Updated:8/25/2018
Start Date:March 19, 2018
End Date:December 2019
Contact:Patricia Saulino, RN MPA
Email:patricia.saulino@inova.org
Phone:703-776-4711

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A Pilot Study Involving the Changes in the Markers of Coagulation During Cardiopulmonary Bypass Surgery Utilizing Acute Normovolemic Hemodilution

This study will help enhance current understanding of the impact of Acute Normovolemic
Hemodilution (ANH) administration on transfusion requirements post cardiac surgery, the
effect of this procedure on coagulation, and platelet hemostasis, and the amount of chest
tube drainage 24 hours post coronary artery bypass graft surgery (CABG) surgery.

Acute Normovolemic Hemodilution (ANH) involves the removal of the patients own blood
immediately at the induction of anesthesia and replacement of this blood intraoperatively
with an equivalent volume of crystalloid or colloid solution in order to dissuade the loss of
red blood cell mass, the mechanism of action is dilution of the blood, hematocrit reduction,
and reduction of the anticoagulant components of the blood associated with bleeding during
cardiopulmonary bypass graft surgery. The collected blood is isolated from the negative
effects of the cardiopulmonary bypass machine.. The collected blood is then stored in
anticoagulant treated blood bags in the cardiovascular operating room and re-infused into the
patient in reverse order of collection at the commencement of surgery, leaving the most cell
rich blood to be re-infused into the patient last. This study will evaluate the effect in
patients with and without ANH utilization on; hemostatic markers, chest tube drainage 24
hours post CABG, and need for allergenic blood transfusion. Positive effects on the
hemostatic markers of anticoagulation and platelets, reduced chest tube drainage at 24 hours
post CABG, and reduced number of transfused red blood cells will indicate a positive
correlation with ANH utilization during isolated on pump CABG surgery.

The benefits of ANH utilization in blood conservation will benefit patients by reducing their
exposure to allogenic blood transfusion with its myriad side effects.

Inclusion Criteria:

1. . Subject is 18-85 years old.

2. . Subject is hemodynamically stable

3. . The subject is able to read and has signed and dated the informed consent document
including Health Insurance Portability and Accountability Act of 1996 (HIPAA)
authorization permitting release of personal health information as approved by the
investigator's Institutional Review Board (IRB).

Exclusion Criteria:

1. . Hematocrit <30 at baseline

2. . Insufficient (Low) on pump hematocrit of < 21%

3. . Patient is hemodynamically unstable

4. . Patient requiring an emergency procedure

5. . Left main coronary artery stenosis with evidence of hemodynamic instability (e.g..
hypotension, ST segment elevations on electrocardiogram)

6. . Aortic valve stenosis with evidence of hemodynamic instability (e.g.. hypotension,
ST segment elevations on electrocardiogram)
We found this trial at
1
site
Falls Church, Virginia 22042
Principal Investigator: Eric L Sarin, MD
Phone: 703-776-4711
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mi
from
Falls Church, VA
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