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

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease

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.

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond,, Virginia, United States, 23298
      • VCU Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Pre-OP, surgery clinics, inpatients

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Collaborators: Daxor Corporation
• Investigators: Principal Investigator: Mark Nelson, MD, VCU Medical Center; Study Chair: Carlos Arancibia, MD, VCU Medical Center

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: April 10, 2008
• First Submitted That Met QC Criteria: April 15, 2008
• First Posted (Estimate): April 17, 2008

Study Record Updates

• Last Update Posted (Estimate): July 5, 2010
• Last Update Submitted That Met QC Criteria: July 2, 2010
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Keywords: Transfusion regulation
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: BVA 100