NCT00812656

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

December 1, 2008

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

December 19, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 22, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

December 3, 2009

Status Verified

December 1, 2009

Enrollment Period

1 year

First QC Date

December 19, 2008

Last Update Submit

December 2, 2009

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in stroke index

    day before surgery; first and second day postoperatively

Study Arms (1)

Stroke Panel group

Patients undergoing cardiac surgery with the use of cardiopulmonary bypass

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients undergoing cardiac surgery with the use of cardiopulmonary bypass

You may qualify if:

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

You may not qualify if:

  • Patients undergoing emergent procedures
  • Patients with preoperative mechanical support

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum Ludwigshafen

Ludwigshafen, RLP, 67063, Germany

Location

Study Officials

  • Stefan W Suttner, MD

    Klinikum Ludwigshafen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 19, 2008

First Posted

December 22, 2008

Study Start

December 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

December 3, 2009

Record last verified: 2009-12

Locations