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Conservation of Red Cell Mass , Oxygen Supply and Demand in Cardiac Surgery

This study has been completed.
Sponsor:
Collaborator:
Daxor Corporation
Information provided by:
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00660608
First received: April 10, 2008
Last updated: July 2, 2010
Last verified: July 2010
  Purpose

Fifty patients will be enrolled into the study. The purpose of the study is to investigate the relevance of Hct levels in determining need for transfusion during operations employing bypass as well as to test the hypothesis that, while HCt levels may decrease during surgery , red blood cell mass and tissue oxygenation remain fairly constant.


Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Conservation of Red Cell Mass, Oxygen Supply and Demand in Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Estimated Enrollment: 50
Study Start Date: April 2008
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Detailed Description:

Fifty adults( male or female-nonpregnant) whose weight is between 55-85 kg and are scheduled to undergo elective cardiac surgery with cardiopulmonary bypass for CABG or primary valve repair or replacement will be eligible. Patients with any history of abnormal bleeding disorders, urgent or emergent need for surgery, and combination surgeries will be excluded. Blood volume analysis will be performed with the DAXOR Blood Volume Analyzer BVA-100 System and the Volumex HSA I-131 radiopharmaceutical for use for determining circulating volume. Multiple timed sample points will be obtained. The DAXOR blood volume analyzer will batch samples and with input of patients height, weight, gender, time of draw, and corresponding Hct, calculate circulating total blood volume. We hypothesize that Total red cell mass is relatively well conserved( <20% decrease) during and immediately after surgery as long as major bleeding does not occur. We hypothesize that decrease in Hct during surgery are related to changes in circulating plasma volume. Total red cell O2 carrying capacity and O2 economics will be measured and it is also hypothesized that lowered Hct values, even as low as 15%, do not independently signal a tissue or whole body O2 deficit.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Pre-OP, surgery clinics, inpatients

Criteria

Inclusion Criteria:

  • Patient scheduled to undergo elective Cabg or primary repair/replacement on bypass pump.
  • Age 18 yrs or older
  • Male or non pregnant female
  • Weight between 55-85 kg.

Exclusion Criteria:

  • Any known bleeding risks;
  • Urgent or emergent surgery;
  • Combined aortic and major vascular surgery;
  • Pregnant women
  • If participating in another study within last 90 days.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00660608

Locations
United States, Virginia
VCU Medical Center
Richmond,, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Daxor Corporation
Investigators
Principal Investigator: Mark Nelson, MD VCU Medical Center
Study Chair: Carlos Arancibia, MD VCU Medical Center
  More Information

No publications provided

Responsible Party: Mark Nelson, MD, VCU Medical Center
ClinicalTrials.gov Identifier: NCT00660608     History of Changes
Other Study ID Numbers: BVA 100
Study First Received: April 10, 2008
Last Updated: July 2, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:
Transfusion regulation

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 23, 2014