NCT00660608

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

April 10, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 17, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

July 5, 2010

Status Verified

July 1, 2010

Enrollment Period

2 years

First QC Date

April 10, 2008

Last Update Submit

July 2, 2010

Conditions

Keywords

Transfusion regulation

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Pre-OP, surgery clinics, inpatients

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VCU Medical Center

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Mark Nelson, MD

    VCU Medical Center

    PRINCIPAL INVESTIGATOR
  • Carlos Arancibia, MD

    VCU Medical Center

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 10, 2008

First Posted

April 17, 2008

Study Start

April 1, 2008

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

July 5, 2010

Record last verified: 2010-07

Locations