Incidence of Acute Cerebrovascular Events Using Either Minimized or Standard Cardiopulmonary Bypass Circuit

Acute Cerebrovascular Events During Extracorporeal Circulation a Comparison of New Minimized Perfusion Circuit to Standard Cardiopulmonary Bypass

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00862160

Acronym

ROCsafeTM

Enrollment

Registered

2009-03-16

Start date

2009-04-30

Completion date

2010-10-31

Last updated

2009-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Cerebrovascular Accident, Coronary Artery Disease, Embolism, Air, Intracranial Embolism

Keywords

coronary artery bypass surgery, cardiopulmonary bypass, heart lung machine, acute cerebrovascular event, intracranial embolism, embolism, air, outcome assessment (health care), neuropsychological tests, magnetic resonance imaging, saccadic eye movement test

Brief summary

The prospective, randomized, two centre study investigates acute cerebrovascular events during extracorporal circulation and the early post operative outcome when using either the minimized cardiopulmonary bypass circuit (ROCsafeTM) or a standard cardiopulmonary bypass circuit in patients undergoing coronary artery bypass grafting.

Detailed description

Coronary artery bypass grafting with extracorporal circulation is established as the golden standard. The conventional cardiopulmonary bypass (CPB) system is associated with inflammatory reaction, hemolysis, hemodilution an disturbances of the blood coagulation system. Also it's well known that neurological disturbances caused by embolic material and air bubbles are potential risks of CPB. The new minimized perfusion circuit ROCsafeTM is a closed, reservoir-less, reduced prime, surface coated circuit, with optimized safety features in effectively eliminate both macro and micro air bubbles and should optimize the clinical outcome after CABG using cardiopulmonary bypass.

Interventions

DEVICEROCsafeTM

using minimized perfusion circuit while CABG

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Patient is older than 17 years * Patient is acceptable candidate for CABG operation * Patient or the patient's legal representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent.

Exclusion criteria

* Ejection fraction less than 30 % * Valve surgery * Acute endocarditis or history of endocarditis * Cerebral ischemia within 4 weeks before surgery * Detection of intracardial thrombi in preoperative echocardiography * Stenosis of A. carotis int. greater than 70 % * Patients older than 80 years * Patients on dialysis * Acute myocardial ischemia or infarction within two weeks before inclusion * Markedly elevated baseline C-reactive protein (CRP) or leucocytosis * Cancer or immunologic diseases * Dysregulation of the coagulation cascade (not concerning INR or PTT under cumarin or heparin treatment) * Intake of steroids or NSAR * Female of childbearing potential * Participation in an other study * Contraindication for MRI (e.g. pacemaker, any kind of implanted metal) * Claustrophobia

Design outcomes

Primary

Measure	Time frame
fresh micro-lesions in cranial MRT	before and 72 h after CABG

Secondary

Measure	Time frame
Death	30 days after CABG
Neurological events	between CABG and discharge
Neurocognitive function	before and 3-4 days after CABG and after 3 months

Countries

Germany

Contacts

Primary ContactIngo Kutschka, PD Dr. med.

kutschka.ingo@mh-hannover.de0049-511-532-2154

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026