Complement Activation and Central Nervous System Injury After Coronary Artery Surgery

U

University Hospital, Angers

Status

Completed

Conditions

Coronary Artery Bypass Grafting

Treatments

Device: heparin-coated cardiopulmonary bypass

Study type

Interventional

Funder types

Other

Identifiers

NCT00188006
PL 97-01

Details and patient eligibility

About

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.

Full 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.

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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