Influence of Extracorporeal Circulation During Cardiac Surgery on the Development of Postoperative Thrombotic Thrombocytopenic Purpura (TTP)

December 28, 2011 updated by: Johann Wolfgang Goethe University Hospital

Influence of Extracorporeal Circulation During Cardiac Surgery on the Development of Postoperative TTP

The purpose of this study is to determine whether extracorporeal circulation during cardiac surgery has an influence on ADAMTS13-Activity.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
    • Hessen
      • Frankfurt, Hessen, Germany, 60590
        • Recruiting
        • Johann Wolfgang Goethe University Hospital
        • Principal Investigator:
          • Wolfgang Miesbach, Dr.med.
        • Sub-Investigator:
          • Imke R Reinecke
        • Sub-Investigator:
          • Christian Weber, Dr.med.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing cardiac surgery at the University Hospital

Description

Inclusion Criteria:

  • cardiac surgery with or without (OPCAB) the use of extracorporeal circulation
  • patient agrees

Exclusion Criteria:

  • no agreement
  • known TTP in medical history

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
with extracorporeal circulation
Patients undergoing cardiac surgery with the use of an extracorporeal circulation
without extracorporeal circulation
Patients undergoing cardiac surgery without the use of extracorporeal circulation (OPCAB)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in ADAMTS13-Activity over time
Time Frame: during surgery (at 1and 2 hours after beginning) and within the first 6 days after surgery
during surgery (at 1and 2 hours after beginning) and within the first 6 days after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in ADAMTS13-Antibody over time
Time Frame: during surgery (at 1and 2 hours after beginning) and within the first 6 days after surgery
during surgery (at 1and 2 hours after beginning) and within the first 6 days after surgery
Change in Platelet count over time
Time Frame: during surgery (at 1and 2 hours after beginning) and within the first 6 days after surgery
during surgery (at 1and 2 hours after beginning) and within the first 6 days after surgery
time duration of extracorporeal circulation during surgery
Time Frame: during surgery
during surgery
Amount of intraoperative given fluid replacement
Time Frame: during surgery
during surgery
Amount of given blood products (red blood cells)
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johann Wolfgang Goethe University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Study Registration Dates

First Submitted

February 18, 2011

First Submitted That Met QC Criteria

February 18, 2011

First Posted (Estimate)

February 21, 2011

Study Record Updates

Last Update Posted (Estimate)

December 29, 2011

Last Update Submitted That Met QC Criteria

December 28, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TTP-KC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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