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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified October 2009 by Hannover Medical School.
Recruitment status was Recruiting

Sponsor:

Collaborators:

Städtisches Klinikum Braunschweig

Terumo Europe N.V.

Information provided by:

Hannover Medical School

ClinicalTrials.gov Identifier:

NCT00862160

First received: March 13, 2009

Last updated: October 6, 2009

Last verified: October 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

March 13, 2009

Last Updated Date

October 6, 2009

Start Date ^ICMJE

April 2009

Estimated Primary Completion Date

April 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

fresh micro-lesions in cranial MRT [ Time Frame: before and 72 h after CABG ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00862160 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Death [ Time Frame: 30 days after CABG ] [ Designated as safety issue: Yes ]
Neurological events [ Time Frame: between CABG and discharge ] [ Designated as safety issue: Yes ]
Neurocognitive function [ Time Frame: before and 3-4 days after CABG and after 3 months ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Coronary Artery Disease
Acute Cerebrovascular Accident
Intracranial Embolism
Embolism, Air

Intervention ^ICMJE

Device: ROCsafeTM

using minimized perfusion circuit while CABG

Study Arm (s)

Active Comparator: 1
using minimized cardiopulmonary bypass circuit ROCsafeTM

Intervention: Device: ROCsafeTM
No Intervention: 2
using standard cardiopulmonary bypass circuit

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

October 2010

Estimated Primary Completion Date

April 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Ingo Kutschka, PD Dr. med.

0049-511-532-2154

kutschka.ingo@mh-hannover.de

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00862160

Other Study ID Numbers ^ICMJE

T201E1

Has Data Monitoring Committee

Yes

Responsible Party

PD Dr. med. Ingo Kutschka, HannoverMS, Clinic of Cardiac Thoracic Transplantation and Vascular Surgery

Study Sponsor ^ICMJE

Hannover Medical School

Collaborators ^ICMJE

Städtisches Klinikum Braunschweig
Terumo Europe N.V.

Investigators ^ICMJE

Principal Investigator:

Ingo Kutschka, PD Dr. med.

Hannover Medical School

Information Provided By

Hannover Medical School

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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