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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00862160
Recruitment Status : Unknown
Verified October 2009 by Hannover Medical School.
Recruitment status was:  Recruiting
First Posted : March 16, 2009
Last Update Posted : October 7, 2009
Städtisches Klinikum Braunschweig
Terumo Europe N.V.
Information provided by:
Hannover Medical School

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Acute Cerebrovascular Accident Intracranial Embolism Embolism, Air Device: ROCsafeTM Phase 4

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acute Cerebrovascular Events During Extracorporeal Circulation a Comparison of New Minimized Perfusion Circuit to Standard Cardiopulmonary Bypass
Study Start Date : April 2009
Estimated Primary Completion Date : April 2010
Estimated Study Completion Date : October 2010

Arm Intervention/treatment
Active Comparator: 1
using minimized cardiopulmonary bypass circuit ROCsafeTM
Device: ROCsafeTM
using minimized perfusion circuit while CABG

No Intervention: 2
using standard cardiopulmonary bypass circuit

Primary Outcome Measures :
  1. fresh micro-lesions in cranial MRT [ Time Frame: before and 72 h after CABG ]

Secondary Outcome Measures :
  1. Death [ Time Frame: 30 days after CABG ]
  2. Neurological events [ Time Frame: between CABG and discharge ]
  3. Neurocognitive function [ Time Frame: before and 3-4 days after CABG and after 3 months ]

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00862160

Contact: Ingo Kutschka, PD Dr. med. 0049-511-532-2154

Klinikum Braunschweig, Department of Cardiothoracic Surgery Recruiting
Braunschweig, Germany, 38126
Contact: Wolfgang Harringer, PD Dr. med.    0049-531-595-2213   
Contact: Aschraf El Essawi, Dr. med.    0049-531-595-2213   
Principal Investigator: Wolfgang Harringer, PD Dr. med.         
Sub-Investigator: Uwe Schönrock         
Sub-Investigator: Aschraf El Essawi, Dr. med.         
Hannover Medical School, Clinic for Cardiac, Thoracic, Transplantation and Vascular Surgery Recruiting
Hannover, Germany, 30625
Contact: Ingo Kutschka, PD Dr. med.    0049-511-532-2154   
Contact: Christian Hagl, PD Dr. med.    0049-511-532-3447   
Principal Investigator: Ingo Kutschka, PD Dr. med.         
Sub-Investigator: Christian Hagl, PD Dr. med.         
Sub-Investigator: Axel Haverich, Prof.         
Sponsors and Collaborators
Hannover Medical School
Städtisches Klinikum Braunschweig
Terumo Europe N.V.
Principal Investigator: Ingo Kutschka, PD Dr. med. Hannover Medical School

Responsible Party: PD Dr. med. Ingo Kutschka, HannoverMS, Clinic of Cardiac Thoracic Transplantation and Vascular Surgery Identifier: NCT00862160     History of Changes
Other Study ID Numbers: T201E1
First Posted: March 16, 2009    Key Record Dates
Last Update Posted: October 7, 2009
Last Verified: October 2009

Keywords provided by Hannover Medical School:
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

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Intracranial Embolism
Embolism, Air
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Embolism and Thrombosis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Intracranial Embolism and Thrombosis