Clinical trial NCT03326323: Biomarker and Thrombogenicity Assessment in Cardiopulmonary Bypass Surgery Utilizing Acute Normovolemic Hemodilution
Official title: A Pilot Study Involving the Changes in the Markers of Coagulation During Cardiopulmonary Bypass Surgery Utilizing Acute Normovolemic Hemodilution
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bleeding Reduction
Keywords: acute normovolemic hemodilution
Lead sponsor: Inova Health Care Services
Sponsor class: OTHER
Collaborators: name: Instrumentation Laboratory
First posted: 2017-10-31
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study population is inclusive of both genders and all racial and ethnic groups and subgroups. Subjects will be enrolled from age 18-85 years old.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Recovery in Platelet Function Post ANH
timeFrame: Baseline through 24 hours post ANH procedure
Secondary outcomes:
measure: Recovery in Mean Clot Firmness Post ANH
timeFrame: Baseline through 24 hours post ANH procedure
Other outcomes:
Locations:
city: Falls Church
country: United States
facility: Inova Heart and Vascular Institute
state: Virginia
Study officials:
affiliation: Inova Heart and Vascular Institute
name: Eric L Sarin, MD
role: PRINCIPAL_INVESTIGATOR
References: