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

Coronary Artery Disease Clinical Trial

— ROCsafeTM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00862160
• Other study ID #: T201E1
• Status: Recruiting
• Phase: Phase 4
• First received: March 13, 2009
• Last updated: October 6, 2009
• Start date: April 2009
• Est. completion date: October 2010

Study information

• Verified date: October 2009
• Source: Hannover Medical School
• Contact: Ingo Kutschka, PD Dr. med.
• Phone: 0049-511-532-2154
• Email: kutschka.ingo[@]mh-hannover.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: October 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Acute Cerebrovascular Accident
• Coronary Artery Disease
• Coronary Disease
• Embolism
• Embolism, Air
• Intracranial Embolism
• Myocardial Ischemia
• Stroke

Intervention

Device:
• ROCsafeTM
using minimized perfusion circuit while CABG

Locations

Country	Name	City	State
Germany	Klinikum Braunschweig, Department of Cardiothoracic Surgery	Braunschweig
Germany	Hannover Medical School, Clinic for Cardiac, Thoracic, Transplantation and Vascular Surgery	Hannover

Sponsors (3)

Lead Sponsor	Collaborator
Hannover Medical School	Städtisches Klinikum Braunschweig, Terumo Europe N.V.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fresh micro-lesions in cranial MRT		before and 72 h after CABG	Yes
Secondary	Death		30 days after CABG	Yes
Secondary	Neurological events		between CABG and discharge	Yes
Secondary	Neurocognitive function		before and 3-4 days after CABG and after 3 months	Yes