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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2011 by Johann Wolfgang Goethe University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01300117
First Posted: February 21, 2011
Last Update Posted: December 29, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Johann Wolfgang Goethe University Hospital
  Purpose
The purpose of this study is to determine whether extracorporeal circulation during cardiac surgery has an influence on ADAMTS13-Activity.

Condition
Cardiac Surgery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Influence of Extracorporeal Circulation During Cardiac Surgery on the Development of Postoperative TTP

Resource links provided by NLM:


Further study details as provided by Johann Wolfgang Goethe University Hospital:

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

Secondary Outcome Measures:
  • Change in ADAMTS13-Antibody over time [ Time Frame: 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 ]
  • time duration of extracorporeal circulation during surgery [ Time Frame: during surgery ]
  • Amount of intraoperative given fluid replacement [ Time Frame: during surgery ]
  • Amount of given blood products (red blood cells) [ Time Frame: 24 hours ]

Estimated Enrollment: 70
Study Start Date: October 2010
Groups/Cohorts
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)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing cardiac surgery at the University Hospital
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • no agreement
  • known TTP in medical history
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01300117


Contacts
Contact: Wolfgang Miesbach +49696301 ext 5051 wolfgang.miesbach@kgu.de
Contact: Imke R Reinecke ireineck@stud.uni-frankfurt.de

Locations
Germany
Johann Wolfgang Goethe University Hospital Recruiting
Frankfurt, Hessen, Germany, 60590
Principal Investigator: Wolfgang Miesbach, Dr.med.         
Sub-Investigator: Imke R Reinecke         
Sub-Investigator: Christian Weber, Dr.med.         
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
  More Information

Responsible Party: Dr. med. W. Miesbach, Hämophilie Zentrum, JWG University Hospital
ClinicalTrials.gov Identifier: NCT01300117     History of Changes
Other Study ID Numbers: TTP-KC
First Submitted: February 18, 2011
First Posted: February 21, 2011
Last Update Posted: December 29, 2011
Last Verified: December 2011

Keywords provided by Johann Wolfgang Goethe University Hospital:
cardiac surgery
adamts13
TTP
extracorporeal circulation
Heart-Lung Machine

Additional relevant MeSH terms:
Purpura, Thrombotic Thrombocytopenic
Purpura, Thrombocytopenic
Purpura
Blood Coagulation Disorders
Hematologic Diseases
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders
Thrombophilia
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms