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

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

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease; Embolism, Air; Intracranial Embolism; Acute Cerebrovascular Accident
• Intervention / Treatment: Device: ROCsafeTM

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
• Enrollment (Anticipated): 64
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Braunschweig, Germany, 38126
    • Recruiting
    • Klinikum Braunschweig, Department of Cardiothoracic Surgery
    • Contact: Wolfgang Harringer, PD Dr. med.; Phone Number: 0049-531-595-2213; Email: w.harringer@klinikum-braunschweig.de
    • Contact: Aschraf El Essawi, Dr. med.; Phone Number: 0049-531-595-2213; Email: a.elessawi@klinikum-braunschweig.de
    • Principal Investigator: Wolfgang Harringer, PD Dr. med.
    • Sub-Investigator: Uwe Schönrock
    • Sub-Investigator: Aschraf El Essawi, Dr. med.
  • Hannover, Germany, 30625
    • Recruiting
    • Hannover Medical School, Clinic for Cardiac, Thoracic, Transplantation and Vascular Surgery
    • Contact: Ingo Kutschka, PD Dr. med.; Phone Number: 0049-511-532-2154; Email: kutschka.ingo@mh-hannover.de
    • Contact: Christian Hagl, PD Dr. med.; Phone Number: 0049-511-532-3447; Email: hagl.christian@mh-hannover.de
    • Principal Investigator: Ingo Kutschka, PD Dr. med.
    • Sub-Investigator: Christian Hagl, PD Dr. med.
    • Sub-Investigator: Axel Haverich, Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Hannover Medical School
• Collaborators: Terumo Europe N.V.; Städtisches Klinikum Braunschweig
• Investigators: Principal Investigator: Ingo Kutschka, PD Dr. med., Hannover Medical School

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Anticipated): April 1, 2010
• Study Completion (Anticipated): October 1, 2010

Study Registration Dates

• First Submitted: March 13, 2009
• First Submitted That Met QC Criteria: March 13, 2009
• First Posted (Estimate): March 16, 2009

Study Record Updates

• Last Update Posted (Estimate): October 7, 2009
• Last Update Submitted That Met QC Criteria: October 6, 2009
• Last Verified: October 1, 2009

More Information

Terms related to this study

• Keywords: magnetic resonance imaging; coronary artery bypass surgery; cardiopulmonary bypass; heart lung machine; neuropsychological tests; acute cerebrovascular event; intracranial embolism; embolism, air; outcome assessment (health care); saccadic eye movement test
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Embolism and Thrombosis; Coronary Disease; Intracranial Embolism and Thrombosis; Thromboembolism; Stroke; Coronary Artery Disease; Embolism; Embolism, Air; Intracranial Embolism
• Other Study ID Numbers: T201E1