NCT00862160

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P25-P50 for phase_4 coronary-artery-disease

Timeline
Completed

Started Apr 2009

Shorter than P25 for phase_4 coronary-artery-disease

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 16, 2009

Completed
16 days until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

October 7, 2009

Status Verified

October 1, 2009

Enrollment Period

1 year

First QC Date

March 13, 2009

Last Update Submit

October 6, 2009

Conditions

Coronary Artery DiseaseAcute Cerebrovascular AccidentIntracranial EmbolismEmbolism, Air

Keywords

coronary artery bypass surgerycardiopulmonary bypassheart lung machineacute cerebrovascular eventintracranial embolismembolism, airoutcome assessment (health care)neuropsychological testsmagnetic resonance imagingsaccadic eye movement test

Outcome Measures

Primary Outcomes (1)

  • fresh micro-lesions in cranial MRT

    before and 72 h after CABG

Secondary Outcomes (3)

  • Death

    30 days after CABG

  • Neurological events

    between CABG and discharge

  • Neurocognitive function

    before and 3-4 days after CABG and after 3 months

Study Arms (2)

1

ACTIVE COMPARATOR

using minimized cardiopulmonary bypass circuit ROCsafeTM

Device: ROCsafeTM

2

NO INTERVENTION

using standard cardiopulmonary bypass circuit

Interventions

ROCsafeTMDEVICE

using minimized perfusion circuit while CABG

1

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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)
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Klinikum Braunschweig, Department of Cardiothoracic Surgery

Braunschweig, 38126, Germany

RECRUITING

Hannover Medical School, Clinic for Cardiac, Thoracic, Transplantation and Vascular Surgery

Hanover, 30625, Germany

RECRUITING

MeSH Terms

Conditions

Coronary Artery DiseaseStrokeIntracranial EmbolismEmbolism, Air

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesIntracranial Embolism and ThrombosisThromboembolismEmbolism and ThrombosisEmbolism

Study Officials

  • Ingo Kutschka, PD Dr. med.

    Hannover Medical School

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ingo Kutschka, PD Dr. med.

CONTACT

0049-511-532-2154kutschka.ingo@mh-hannover.de

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 13, 2009

First Posted

March 16, 2009

Study Start

April 1, 2009

Primary Completion

April 1, 2010

Study Completion

October 1, 2010

Last Updated

October 7, 2009

Record last verified: 2009-10

Locations

DE(2)