Complement Activation and Central Nervous System Injury After Coronary Artery Surgery

NCT00188006 | Completed

• 1 other identifier: PL 97-01
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Coronary Artery Bypass Grafting

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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)

Interventions

heparin-coated cardiopulmonary bypass DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• men undergoing coronary artery bypass surgery using cardiopulmonary bypass

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Angers: lead

Related Publications (1)

• 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.

  PMID: 15854939 RESULT

Related Links

• The CardioThoracic Surgery Network
• University Hospital of Angers, France

Study Officials

• Christophe BAUFRETON, MD PhD

  University Hospital of Angers, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 16, 2005
• Last Updated: September 16, 2005

Record last verified: 2005-09