Incidence of Acute Cerebrovascular Events Using Either Mi... | NCT00862160

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

NCT00862160

Sponsor

Hannover Medical School

Status

Unknown status

Last Update Posted

Oct 7, 2009Estimated

Enrollment

64Estimated

Phase

Phase 4

Conditions

Coronary Artery Disease
Acute Cerebrovascular Accident
Intracranial Embolism
Embolism, Air

Interventions

ROCsafeTM

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Apr 2010Estimated

Completion Date

Oct 2010Estimated

First Submitted Date

Mar 13, 2009

First Submission Date that Met QC Criteria

Mar 13, 2009

First Posted Date

Mar 16, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 6, 2009

Last Update Posted Date

Oct 7, 2009Estimated

Name	Class
Academic Teaching Hospital Braunschweig	OTHER
Terumo Europe N.V.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Conditions Module

Conditions

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

64Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	using minimized cardiopulmonary bypass circuit ROCsafeTM	Device: ROCsafeTM
2	No Intervention	using standard cardiopulmonary bypass circuit

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ROCsafeTM	Device	using minimized perfusion circuit while CABG	1

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Death		30 days after CABG
Neurological events		between CABG and discharge
Neurocognitive function

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ingo Kutschka, PD Dr. med.	Contact	0049-511-532-2154		kutschka.ingo@mh-hannover.de

Overall Officials

Name	Affiliation	Role
Ingo Kutschka, PD Dr. med.	Hannover Medical School	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinikum Braunschweig, Department of Cardiothoracic Surgery	Recruiting	Braunschweig		38126	Germany

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease
D020521	Stroke
D020766	Intracranial Embolism
D004618	Embolism, Air

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided