Cardiopulmonary BypassNCT00187967
Cardiopulmonary Bypass (CPB) Pumps and Blood Activation
A study testing pumps used for cardiopulmonary bypass in people with Cardiopulmonary Bypass and Coronary Artery Disease, run by University Hospital, Angers at 1 site in France.
Trial summary
Blood activation induced by cardiopulmonary bypass may compromise the postoperative outcome. The goal of this study is to compare blood activation induced by cardiopulmonary bypass performed with centrifugal pump or roller pump in patients undergoing coronary artery surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Cardiopulmonary Bypass, Coronary Artery Disease
- What is being tested?
- pumps used for cardiopulmonary bypass
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 1 siteFrance
- Study dates
- Jan 2005to not given
- Phase
- Interventional
- 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 years and older
- Men only
- Adult, Older adult
Who may be able to join
- Men undergoing coronary artery bypass grafting using cardiopulmonary bypass
- Aspirin therapy
Who cannot join
- Redo surgery
- Acute coronary syndrome requiring urgent surgery
- Oral anticoagulant therapy
- Organ dysfunction or chronic inflammatory disease
- Surgery other than coronary artery bypass grafting
Trial locations and contacts
1 site in 1 country.
Anthony Bailleul contact
France1 site, 1 recruiting
- Recruiting
University Hospital of Angers
Angers, 49933
Christophe Baufreton, MD, PhD, 33-(0)2-41-35-45-73, ChBaufreton@chu-angers.fr
Anthony Bailleul, 33-(0)2-41-35-58-91
About this study
Official title: Blood Activation During Cardiopulmonary Bypass Using Roller or Centrifugal Pumps
Blood activation induced by cardiopulmonary bypass may compromise the postoperative outcome. The goal of this study is to compare blood activation induced by cardiopulmonary bypass performed with centrifugal pump or roller pump in patients undergoing coronary artery surgery.
- Conditions
- Cardiopulmonary Bypass, Coronary Artery Disease
- Being tested
- pumps used for cardiopulmonary bypass
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pumps used for cardiopulmonary bypassDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiopulmonary BypassStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Investigators
- Christophe Baufreton, MD, PhD, Principal investigator, University Hospital of Angers, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00187967
- Sponsor's protocol ID
- PHRC 03-03
- Status last verified
- Sep 2005
- First submitted
- 9 Sep 2005
- Last updated
- 26 Sep 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Activation During Cardiopulmonary Bypass Using Roller or Centrifugal Pumps
- ClinicalTrials.gov ID
- NCT00187967
- Acronym / sponsor ID
- PHRC 03-03
- Conditions
- Cardiopulmonary Bypass, Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Jan 2005
- First posted
- 16 Sep 2005 (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.
Blood activation induced by cardiopulmonary bypass may compromise the postoperative outcome. The goal of this study is to compare blood activation induced by cardiopulmonary bypass performed with centrifugal pump or roller pump in patients undergoing coronary artery surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men undergoing coronary artery bypass grafting using cardiopulmonary bypass
- Aspirin therapy
Key exclusion criteria (5 listed)
- Redo surgery
- Acute coronary syndrome requiring urgent surgery
- Oral anticoagulant therapy
- Organ dysfunction or chronic inflammatory disease
- Surgery other than coronary artery bypass grafting
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pumps used for cardiopulmonary bypass | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2007.
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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.
Anthony Bailleul contact
Christophe Baufreton, MD, PhD principal investigator
University Hospital of Angers, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pumps used for cardiopulmonary bypass in people with Cardiopulmonary Bypass and Coronary Artery Disease, run by University Hospital, Angers at 1 site in France.
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 2 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: status not confirmed, as of the sponsor's last update on 26 Sep 2007. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anthony Bailleul (33-(0)2-41-35-58-91), or a site near the patient. 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 26 Sep 2007.