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Complement Activation and Central Nervous System Injury After Coronary Artery Surgery

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ClinicalTrials.gov Identifier: NCT00188006
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : September 16, 2005
Sponsor:
Information provided by:
University Hospital, Angers

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.


Condition or disease Intervention/treatment Phase
Coronary Artery Bypass Grafting Device: heparin-coated cardiopulmonary bypass Not Applicable

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.


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

Resource links provided by the National Library of Medicine

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




Primary Outcome Measures :
  1. sC5b-9 release
  2. s100beta release

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


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00188006


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

Additional Information:
Publications of Results:
ClinicalTrials.gov Identifier: NCT00188006     History of Changes
Other Study ID Numbers: PL 97-01
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: September 16, 2005
Last Verified: September 2005

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

Additional relevant MeSH terms:
Heparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action