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Complement Activation and Central Nervous System Injury After Coronary Artery Surgery

Biocompatible Cardiopulmonary Bypass and Neuropsychological Outcome After Coronary Artery Bypass Surgery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00188006
Enrollment
Unknown
Registered
2005-09-16
Start date
Unknown
Completion date
Unknown
Last updated
2005-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Bypass Grafting

Keywords

cardiopulmonary bypass, inflammatory response, neurologic injury, neurocognitive deficit, biomaterials, coronary artery bypass surgery

Brief 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. 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.

Interventions

DEVICEheparin-coated cardiopulmonary bypass

Sponsors

University Hospital, Angers
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* men undergoing coronary artery bypass surgery using cardiopulmonary bypass

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frame
sC5b-9 release
s100beta release

Secondary

MeasureTime frame
changes in neuropsychological functioning (z scores of cognitive domains)
blood flow velocity in the middle cerebral artery (subgroup)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026