Coronary Artery Bypass GraftingNCT00188006
Complement Activation and Central Nervous System Injury After Coronary Artery Surgery
A study testing heparin-coated cardiopulmonary bypass in people with Coronary Artery Bypass Grafting, run by University Hospital, Angers.
Trial summary
The impact of the postoperative inflammatory response on the central nervous system after cardiac surgery is uncertain. The goal of this study was to evaluate the role of complement activation on cellular brain injury and neurological functioning 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
- Coronary Artery Bypass Grafting
- What is being tested?
- heparin-coated cardiopulmonary bypass
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- men undergoing coronary artery bypass surgery using cardiopulmonary bypass
Who cannot join
- clinical conditions expected to potentially influence the magnitude of the systemic inflammatory response after surgery such as open heart surgery, women because they show higher complement activation after surgery, redo cases, organ dysfunction as defined by the Euroscore such as chronic airway disease or renal dysfunction with creatinine level above 200 µmol/L, patients with left ventricular ejection fraction below 35%, diabetes mellitus under insulin therapy prior to the operation, presence of active inflammatory disease or patients taking anti-inflammatory drugs (except acetylsalicylic acid).
- significant carotid artery stenoses (>70%) at the preoperative echo-doppler examination, evidence of preexisting neurologic or psychiatric disease, existence of preoperative neuropsychological impairment as defined by preoperative Mini-Mental State Examination (MMSE) below 27, and alcohol addiction.
About this study
Official title: Biocompatible Cardiopulmonary Bypass and Neuropsychological Outcome After Coronary Artery Bypass Surgery
The impact of the postoperative inflammatory response on the central nervous system after cardiac surgery is uncertain.
The goal of this study was to evaluate the role of complement activation on cellular brain injury and neurological functioning in patients undergoing coronary artery surgery. In addition, the effect of complement activation on the cerebral vasomotricity was assessed.
Because receptors to activated complement are present on astrocytes, the heparin-coated cardiopulmonary bypass that reduces complement activation should minimize these postoperative neurological adverse events. Heparin-coating might also influence blood flow velocity in cerebral arteries postoperatively if complement activation mediates cardiopulmonary bypass induced cerebral vasomotor dysfunction.
Read the detailed description
Closed cardiopulmonary bypass and controlled suctions of pericardial shed blood were standardized in all patients.
Bedside transcranial Doppler examination served to evaluate the development of cerebral vasomotor dysfunction in a subgroup of patients.
- Conditions
- Coronary Artery Bypass Grafting
- Being tested
- heparin-coated cardiopulmonary bypass
- Keywords
- cardiopulmonary bypass, inflammatory response, neurologic injury, neurocognitive deficit, biomaterials, coronary artery bypass surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
heparin-coated cardiopulmonary bypassDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
sC5b-9 release
s100beta release
Secondary outcomes (2)
changes in neuropsychological functioning (z scores of cognitive domains)
blood flow velocity in the middle cerebral artery (subgroup)
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)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery Bypass GraftingStudies 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
- NCT00188006
- Sponsor's protocol ID
- PL 97-01
- Status last verified
- Sep 2005
- First submitted
- 9 Sep 2005
- Last updated
- 16 Sep 2005
- Results posted
- No
Publications
Baufreton C, Allain P, Chevailler A, Etcharry-Bouyx F, Corbeau JJ, Legall D, de Brux JL. Brain injury and neuropsychological outcome after coronary artery surgery are affected by complement activation. Ann Thorac Surg. 2005 May;79(5):1597-605. doi: 10.1016/j.athoracsur.2004.08.061.
PubMed 15854939
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biocompatible Cardiopulmonary Bypass and Neuropsychological Outcome After Coronary Artery Bypass Surgery
- ClinicalTrials.gov ID
- NCT00188006
- Acronym / sponsor ID
- PL 97-01
- Conditions
- Coronary Artery Bypass Grafting
- Keywords
- cardiopulmonary bypass, inflammatory response, neurologic injury, neurocognitive deficit, biomaterials, coronary artery bypass surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University Hospital, AngersOther government
- 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.
The impact of the postoperative inflammatory response on the central nervous system after cardiac surgery is uncertain.
The goal of this study was to evaluate the role of complement activation on cellular brain injury and neurological functioning in patients undergoing coronary artery surgery. In addition, the effect of complement activation on the cerebral vasomotricity was assessed.
Because receptors to activated complement are present on astrocytes, the heparin-coated cardiopulmonary bypass that reduces complement activation should minimize these postoperative neurological adverse events. Heparin-coating might also influence blood flow velocity in cerebral arteries postoperatively if complement activation mediates cardiopulmonary bypass induced cerebral vasomotor dysfunction.
Detailed description
Closed cardiopulmonary bypass and controlled suctions of pericardial shed blood were standardized in all patients.
Bedside transcranial Doppler examination served to evaluate the development of cerebral vasomotor dysfunction in a subgroup of patients.
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
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- men undergoing coronary artery bypass surgery using cardiopulmonary bypass
Key exclusion criteria (2 listed)
- clinical conditions expected to potentially influence the magnitude of the systemic inflammatory response after surgery such as open heart surgery, women because they show higher complement activation after surgery, redo cases, organ dysfunction as defined by the Euroscore such as chronic airway disease or renal dysfunction with creatinine level above 200 µmol/L, patients with left ventricular ejection fraction below 35%, diabetes mellitus under insulin therapy prior to the operation, presence of active inflammatory disease or patients taking anti-inflammatory drugs (except acetylsalicylic acid).
- significant carotid artery stenoses (>70%) at the preoperative echo-doppler examination, evidence of preexisting neurologic or psychiatric disease, existence of preoperative neuropsychological impairment as defined by preoperative Mini-Mental State Examination (MMSE) below 27, and alcohol addiction.
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 |
|---|---|---|
| heparin-coated cardiopulmonary bypass | Device | – |
Primary outcome
sC5b-9 release
s100beta release
2 secondary outcomes
changes in neuropsychological functioning (z scores of cognitive domains)
blood flow velocity in the middle cerebral artery (subgroup)
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 16 Sep 2005.
- Results publication: PubMed 15854939Baufreton C, Allain P, Chevailler A, Etcharry-Bouyx F, Corbeau JJ, Legall D, de Brux JL. Brain injury and neuropsychological outcome after coronary artery surgery are affected by complement activation. Ann Thorac Surg. 2005 May;79(5):1597-605. doi: 10.1016/j.athoracsur.2004.08.061.
- University Hospital of Angers, FranceLink provided by the sponsor.
Related trials for Coronary Artery Bypass Grafting
Not yet recruiting
Partial Cardiac Denervation for Preventing Atrial Fibrillation After CABG
Postoperative Atrial Fibrillation, Coronary Artery Disease
Active, not recruiting
Investigation of the Effects of Respiratory Muscle Training Combined With Otago Exercises in Elderly Patients Undergoing Coronary Artery Bypass Graft Surgery
Coronary Artery Bypass Graft (CABG)
Recruiting
Postural Mobilization Compared to Noradrenaline Only in Off-Pump CABG Surgery
Coronary Artery Disease With Need for Bypass Surgery, Coronary Artery Disease(CAD)
Active, not recruitingPhase 1
Comparison of Analgesic Efficacy Between Ultrasound Guided Serratus Anterior Plane Block or Thoracic Paravertebral Block Versus Intravenous Fentanyl for On-pump Coronary Artery Bypass Graft Surgery
Intra and Post Operative Pain Management, Fast Track Program,(Enhanced Recovery After Surgery (ERAS))
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
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.
Christophe BAUFRETON, MD PhD principal investigator
University Hospital of Angers, France
Questions about this trial
What is this clinical trial studying?
A study testing heparin-coated cardiopulmonary bypass in people with Coronary Artery Bypass Grafting, run by University Hospital, Angers.
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 1 inclusion and 2 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 16 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
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.
What does the primary outcome measure?
sC5b-9 release. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00188006, which also lists 1 linked publication.
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 16 Sep 2005.