Complement Activation and Central Nervous System Injury After Coronary Artery Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Coronary Artery Bypass Grafting

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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heparin-coated cardiopulmonary bypass

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Principal Investigators

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Christophe BAUFRETON, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Angers, France

References

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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.

Reference Type RESULT

PMID: 15854939 (View on PubMed)

Other Identifiers

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PL 97-01

Identifier Type: -

Identifier Source: org_study_id