Serial Measurement of a Plasma Stroke Biomarker Panel in... | NCT00812656

Studies
Serial Measurement of a Plasma Stroke Biomarker Panel in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass

NCT00812656

Sponsor

Klinikum Ludwigshafen

Status

Completed

Last Update Posted

Dec 3, 2009Estimated

Enrollment

50Actual

Phase

Not provided

Conditions

Cardiac Surgery

Interventions

Not provided

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

Dec 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2008

Primary Completion Date

Dec 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Dec 19, 2008

First Submission Date that Met QC Criteria

Dec 19, 2008

First Posted Date

Dec 22, 2008Estimated

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

Dec 2, 2009

Last Update Posted Date

Dec 3, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Stroke Panel group		Patients undergoing cardiac surgery with the use of cardiopulmonary bypass

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in stroke index		day before surgery; first and second day postoperatively

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult patients undergoing cardiac surgery with the use of cardiopulmonary bypass

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stefan W Suttner, MD	Klinikum Ludwigshafen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinikum Ludwigshafen		Ludwigshafen	RLP	67063	Germany