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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00660608
• Other study ID #: BVA 100
• Status: Completed
• Phase: N/A
• First received: April 10, 2008
• Last updated: July 2, 2010
• Start date: April 2008
• Est. completion date: April 2010

Study information

• Verified date: July 2010
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
United States	VCU Medical Center	Richmond,	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	Daxor Corporation

Country where clinical trial is conducted

United States,