Coronary Artery DiseaseNCT00660608
Conservation of Red Cell Mass , Oxygen Supply and Demand in Cardiac Surgery
An observational study of Coronary Artery Disease, run by Virginia Commonwealth University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Apr 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pre-OP, surgery clinics, inpatients
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Keywords
- Transfusion regulation
- Medical subject headings
- Coronary Artery Disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- Daxor Corporation
- Investigators
- Mark Nelson, MD, Principal investigator, VCU Medical CenterCarlos Arancibia, MD, Study chair, VCU Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00660608
- Sponsor's protocol ID
- BVA 100
- Status last verified
- Jul 2010
- First submitted
- 10 Apr 2008
- Last updated
- 5 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conservation of Red Cell Mass, Oxygen Supply and Demand in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT00660608
- Acronym / sponsor ID
- BVA 100
- Conditions
- Coronary Artery Disease
- Keywords
- Transfusion regulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- Daxor Corporation
- Study start
- Apr 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 17 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pre-OP, surgery clinics, inpatients
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Nelson, MD principal investigator
VCU Medical Center
Carlos Arancibia, MD study chair
VCU Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2010.