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

Primary Purpose

Coronary Artery Disease, Acute Cerebrovascular Accident, Intracranial Embolism

Status
Unknown status
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
ROCsafeTM
Sponsored by
Hannover Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring 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

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Klinikum Braunschweig, Department of Cardiothoracic SurgeryRecruiting
  • Hannover Medical School, Clinic for Cardiac, Thoracic, Transplantation and Vascular SurgeryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

1

2

Arm Description

using minimized cardiopulmonary bypass circuit ROCsafeTM

using standard cardiopulmonary bypass circuit

Outcomes

Primary Outcome Measures

fresh micro-lesions in cranial MRT

Secondary Outcome Measures

Death
Neurological events
Neurocognitive function

Full Information

First Posted
March 13, 2009
Last Updated
October 6, 2009
Sponsor
Hannover Medical School
Collaborators
Städtisches Klinikum Braunschweig, Terumo Europe N.V.
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1. Study Identification

Unique Protocol Identification Number
NCT00862160
Brief Title
Incidence of Acute Cerebrovascular Events Using Either Minimized or Standard Cardiopulmonary Bypass Circuit
Acronym
ROCsafeTM
Official Title
Acute Cerebrovascular Events During Extracorporeal Circulation a Comparison of New Minimized Perfusion Circuit to Standard Cardiopulmonary Bypass
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Unknown status
Study Start Date
April 2009 (undefined)
Primary Completion Date
April 2010 (Anticipated)
Study Completion Date
October 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Hannover Medical School
Collaborators
Städtisches Klinikum Braunschweig, Terumo Europe N.V.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Acute Cerebrovascular Accident, Intracranial Embolism, Embolism, Air
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
using minimized cardiopulmonary bypass circuit ROCsafeTM
Arm Title
2
Arm Type
No Intervention
Arm Description
using standard cardiopulmonary bypass circuit
Intervention Type
Device
Intervention Name(s)
ROCsafeTM
Intervention Description
using minimized perfusion circuit while CABG
Primary Outcome Measure Information:
Title
fresh micro-lesions in cranial MRT
Time Frame
before and 72 h after CABG
Secondary Outcome Measure Information:
Title
Death
Time Frame
30 days after CABG
Title
Neurological events
Time Frame
between CABG and discharge
Title
Neurocognitive function
Time Frame
before and 3-4 days after CABG and after 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ingo Kutschka, PD Dr. med.
Phone
0049-511-532-2154
Email
kutschka.ingo@mh-hannover.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ingo Kutschka, PD Dr. med.
Organizational Affiliation
Hannover Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinikum Braunschweig, Department of Cardiothoracic Surgery
City
Braunschweig
ZIP/Postal Code
38126
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wolfgang Harringer, PD Dr. med.
Phone
0049-531-595-2213
Email
w.harringer@klinikum-braunschweig.de
First Name & Middle Initial & Last Name & Degree
Aschraf El Essawi, Dr. med.
Phone
0049-531-595-2213
Email
a.elessawi@klinikum-braunschweig.de
First Name & Middle Initial & Last Name & Degree
Wolfgang Harringer, PD Dr. med.
First Name & Middle Initial & Last Name & Degree
Uwe Schönrock
First Name & Middle Initial & Last Name & Degree
Aschraf El Essawi, Dr. med.
Facility Name
Hannover Medical School, Clinic for Cardiac, Thoracic, Transplantation and Vascular Surgery
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ingo Kutschka, PD Dr. med.
Phone
0049-511-532-2154
Email
kutschka.ingo@mh-hannover.de
First Name & Middle Initial & Last Name & Degree
Christian Hagl, PD Dr. med.
Phone
0049-511-532-3447
Email
hagl.christian@mh-hannover.de
First Name & Middle Initial & Last Name & Degree
Ingo Kutschka, PD Dr. med.
First Name & Middle Initial & Last Name & Degree
Christian Hagl, PD Dr. med.
First Name & Middle Initial & Last Name & Degree
Axel Haverich, Prof.

12. IPD Sharing Statement

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

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