NCT01354847

Brief Summary

This study is planned to investigate the relationship between duration of extracorporeal circulation and the extent of (acquired) platelet dysfunctions in patients undergoing cardiac surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2011

Typical duration 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

First Submitted

Initial submission to the registry

May 2, 2011

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 17, 2011

Completed
15 days until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

October 28, 2013

Status Verified

October 1, 2013

Enrollment Period

2.3 years

First QC Date

May 2, 2011

Last Update Submit

October 25, 2013

Conditions

Acquired Platelet Function Disorder

Keywords

extracorporeal circulationplatelet dysfunctionMultiplate electrode aggregometry analysesMultiplate

Outcome Measures

Primary Outcomes (1)

  • Changes in arachidonic acid induced platelet aggregation as compared to baseline (before extracorporeal circulation)

    Multiple Electrode aggregometry parameters

    Baseline (before extracorporeal circulation) and 60, 90, 120, 150 and 180 minutes after extracorporal circulation as well as ad admission to ICU

Secondary Outcomes (1)

  • Changes in Adenosin Diphosphate (ADP) and Thrombin induced platelet aggregation as compared to baseline (before extracorporeal circulation)

    Baseline (before extracorporeal circulation) and 60, 90, 120, 150 and 180 minutes after extracorporal circulation as well as ad admission to ICU

Study Arms (1)

cardiac surgery patients

cardiac surgery patients scheduled for elective complex cardiac surgery

Device: Multiple electrode aggregometry analyses (Multiple Electrode Aggregometry, Multiplate(R), Verum Diagnostica, Munich, Germany)

Interventions

Multiple electrode aggregometry analyses (Multiple Electrode Aggregometry, Multiplate(R), Verum Diagnostica, Munich, Germany)DEVICE

ex vivo platelet aggregation at several intraoperative and postoperative measuring points.

cardiac surgery patients

Eligibility Criteria

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

Cardiac surgery patients undergoing complex cardiac surgery (double valve, aortic surgery, combined - or redo procedures)

You may qualify if:

  • duration of extracorporeal circulation \> 120 min

You may not qualify if:

  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Goethe - University

Frankfurt am Main, Hesse, 60322, Germany

Location

Related Publications (1)

  • Velik-Salchner C, Maier S, Innerhofer P, Kolbitsch C, Streif W, Mittermayr M, Praxmarer M, Fries D. An assessment of cardiopulmonary bypass-induced changes in platelet function using whole blood and classical light transmission aggregometry: the results of a pilot study. Anesth Analg. 2009 Jun;108(6):1747-54. doi: 10.1213/ane.0b013e3181a198ac.

    PMID: 19448196BACKGROUND

Study Officials

  • Christian F Weber, M.D.

    Goethe University Frankfurt, Theodor Stern Kai 7, 60590 Frankfurt, Germany

    PRINCIPAL INVESTIGATOR

  • Christian Reyher, M.D.

    Goethe University Frankfurt, Clinic for Anesthesiology, Theodor Stern Kai 7, 60590 Frankfurt, Germany

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Dr. Christian Friedrich Weber

Study Record Dates

First Submitted

May 2, 2011

First Posted

May 17, 2011

Study Start

June 1, 2011

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

October 28, 2013

Record last verified: 2013-10

Locations

DE(1)