Status:

COMPLETED

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

Lead Sponsor:

Inova Health Care Services

Collaborating Sponsors:

Instrumentation Laboratory

Conditions:

Bleeding Reduction

Eligibility:

All Genders

18-85 years

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 ...

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...

Eligibility Criteria

Inclusion

  • . Subject is 18-85 years old.
  • . Subject is hemodynamically stable
  • . 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

  • . Hematocrit \<30 at baseline
  • . Insufficient (Low) on pump hematocrit of \< 21%
  • . Patient is hemodynamically unstable
  • . Patient requiring an emergency procedure
  • . Left main coronary artery stenosis with evidence of hemodynamic instability (e.g.. hypotension, ST segment elevations on electrocardiogram)
  • . Aortic valve stenosis with evidence of hemodynamic instability (e.g.. hypotension, ST segment elevations on electrocardiogram)

Key Trial Info

Start Date :

March 19 2018

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

October 17 2019

Estimated Enrollment :

43 Patients enrolled

Trial Details

Trial ID

NCT03326323

Start Date

March 19 2018

End Date

October 17 2019

Last Update

January 13 2020

Active Locations (1)

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Inova Heart and Vascular Institute

Falls Church, Virginia, United States, 22042