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
  Purpose

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 Intervention Phase
Coronary Artery Disease
Acute Cerebrovascular Accident
Intracranial Embolism
Embolism, Air
Device: ROCsafeTM
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acute Cerebrovascular Events During Extracorporeal Circulation a Comparison of New Minimized Perfusion Circuit to Standard Cardiopulmonary Bypass

Resource links provided by NLM:


Further study details as provided by Hannover Medical School:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 64
Study Start Date: April 2009
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00862160

Contacts
Contact: Ingo Kutschka, PD Dr. med. 0049-511-532-2154 kutschka.ingo@mh-hannover.de

Locations
Germany
Klinikum Braunschweig, Department of Cardiothoracic Surgery Recruiting
Braunschweig, Germany, 38126
Contact: Wolfgang Harringer, PD Dr. med.    0049-531-595-2213    w.harringer@klinikum-braunschweig.de   
Contact: Aschraf El Essawi, Dr. med.    0049-531-595-2213    a.elessawi@klinikum-braunschweig.de   
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    kutschka.ingo@mh-hannover.de   
Contact: Christian Hagl, PD Dr. med.    0049-511-532-3447    hagl.christian@mh-hannover.de   
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.
Investigators
Principal Investigator: Ingo Kutschka, PD Dr. med. Hannover Medical School
  More Information

No publications provided

Responsible Party: PD Dr. med. Ingo Kutschka, HannoverMS, Clinic of Cardiac Thoracic Transplantation and Vascular Surgery
ClinicalTrials.gov Identifier: NCT00862160     History of Changes
Other Study ID Numbers: T201E1
Study First Received: March 13, 2009
Last Updated: October 6, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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:
Embolism and Thrombosis
Intracranial Embolism and Thrombosis
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Embolism
Embolism, Air
Cerebral Infarction
Stroke
Intracranial Embolism
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Thromboembolism
Thrombosis

ClinicalTrials.gov processed this record on July 31, 2014