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Complement Activation and Central Nervous System Injury After Coronary Artery Surgery

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Angers
ClinicalTrials.gov Identifier:
NCT00188006
First received: September 9, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

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.


Condition Intervention
Coronary Artery Bypass Grafting
 Device: heparin-coated cardiopulmonary bypass

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Biocompatible Cardiopulmonary Bypass and Neuropsychological Outcome After Coronary Artery Bypass Surgery

Resource links provided by NLM:

Drug Information available for: Heparin
U.S. FDA Resources

Further study details as provided by University Hospital, Angers:

Primary Outcome Measures:
  • sC5b-9 release
  • s100beta release

Secondary Outcome Measures:
  • changes in neuropsychological functioning (z scores of cognitive domains)
  • blood flow velocity in the middle cerebral artery (subgroup)

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00188006

Sponsors and Collaborators
University Hospital, Angers
Investigators
Principal Investigator: Christophe BAUFRETON, MD PhD University Hospital of Angers, France
  More Information

Additional Information:
The CardioThoracic Surgery Network  This link exits the ClinicalTrials.gov site
University Hospital of Angers, France  This link exits the ClinicalTrials.gov site
Faculty of Medicine, University of Angers  This link exits the ClinicalTrials.gov site

Publications:

ClinicalTrials.gov Identifier: NCT00188006     History of Changes
Other Study ID Numbers: PL 97-01
Study First Received: September 9, 2005
Last Updated: September 9, 2005
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Angers:
cardiopulmonary bypass, inflammatory response
neurologic injury
neurocognitive deficit
biomaterials
coronary artery bypass surgery

Additional relevant MeSH terms:
Trauma, Nervous System
Nervous System Diseases
Wounds and Injuries

ClinicalTrials.gov processed this record on May 19, 2013