Clinical trial NCT00188006: Complement Activation and Central Nervous System Injury After Coronary Artery Surgery
Official title: Biocompatible Cardiopulmonary Bypass and Neuropsychological Outcome After Coronary Artery Bypass Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Bypass Grafting
Keywords: cardiopulmonary bypass, inflammatory response
neurologic injury
neurocognitive deficit
biomaterials
coronary artery bypass surgery
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2005-09-16
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: sC5b-9 release
measure: s100beta release
Secondary outcomes:
measure: changes in neuropsychological functioning (z scores of cognitive domains)
measure: blood flow velocity in the middle cerebral artery (subgroup)
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital of Angers, France
name: Christophe BAUFRETON, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.