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Serial Measurement of a Plasma Stroke Biomarker Panel in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass (Stroke08)
This study is currently recruiting participants.
Verified by Klinikum Ludwigshafen, December 2008
Sponsored by: Klinikum Ludwigshafen
Information provided by: Klinikum Ludwigshafen
ClinicalTrials.gov Identifier: NCT00812656
  Purpose

The purpose of this study is to investigate changes in new plasma stroke biomarker panel in patients undergoing cardiac surgery with the use of cardiopulmonary bypass.


Condition
Cardiac Surgery

MedlinePlus related topics: Heart Surgery
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Serial Measurement of a Plasma Stroke Biomarker Panel in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass

Further study details as provided by Klinikum Ludwigshafen:

Primary Outcome Measures:
  • Change in stroke index [ Time Frame: day before surgery; first and second day postoperatively ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 50
Study Start Date: December 2008
Estimated Study Completion Date: April 2009
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Stroke Panel group
Patients undergoing cardiac surgery with the use of cardiopulmonary bypass

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Adult patients undergoing cardiac surgery with the use of cardiopulmonary bypass

Criteria

Inclusion Criteria:

  • Age > 18 years
  • Elective cardiac surgery with the use of cardiopulmonary bypass

Exclusion Criteria:

  • Patients undergoing emergent procedures
  • Patients with preoperative mechanical support
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00812656

Contacts
Contact: Stefan W Suttner, MD 0621503 ext 3000 suttner@gmx.de
Contact: Joachim Boldt, MD 0621503 ext 3000 boldtj@gmx.net

Locations
Germany, RLP
Klinikum Ludwigshafen Recruiting
Ludwigshafen, RLP, Germany, 67063
Contact: Stefan W Suttner, MD     0621503 ext 3000     suttner@gmx.de    
Contact: Joachim Boldt, MD     0621503 ext 3000     boldtj@gmx.net    
Principal Investigator: Stefan W Suttner, MD            
Sponsors and Collaborators
Klinikum Ludwigshafen
Investigators
Principal Investigator: Stefan W Suttner, MD Klinikum Ludwigshafen
  More Information

Responsible Party: Klinikum Ludwigshafen ( Prof. Dr. J. Boldt )
Study ID Numbers: StrokePanel08
Study First Received: December 19, 2008
Last Updated: December 19, 2008
ClinicalTrials.gov Identifier: NCT00812656  
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:
Cerebral Infarction
Stroke

ClinicalTrials.gov processed this record on January 13, 2009