Complement Activation and Central Nervous System Injury After Coronary Artery Surgery

Coronary Artery Bypass Grafting Clinical Trial

Official title:

Biocompatible Cardiopulmonary Bypass and Neuropsychological Outcome After Coronary Artery Bypass Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00188006
• Other study ID #: PL 97-01
• Status: Completed
• Phase: N/A
• First received: September 9, 2005
• Last updated: September 9, 2005

Study information

• Verified date: September 2005
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Bypass Grafting

Intervention

Device:
• heparin-coated cardiopulmonary bypass

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sC5b-9 release
Primary	s100beta release
Secondary	changes in neuropsychological functioning (z scores of cognitive domains)
Secondary	blood flow velocity in the middle cerebral artery (subgroup)

External Links

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