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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Johann Wolfgang Goethe University Hospitals.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT01300117
First received: February 18, 2011
Last updated: December 28, 2011
Last verified: December 2011
  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 Hospitals:

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Change in Platelet count over time [ Time Frame: during surgery (at 1and 2 hours after beginning) and within the first 6 days after surgery ] [ Designated as safety issue: No ]
  • time duration of extracorporeal circulation during surgery [ Time Frame: during surgery ] [ Designated as safety issue: No ]
  • Amount of intraoperative given fluid replacement [ Time Frame: during surgery ] [ Designated as safety issue: No ]
  • Amount of given blood products (red blood cells) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Hospitals
  More Information

No publications provided

Responsible Party: Dr. med. W. Miesbach, Hämophilie Zentrum, JWG University Hospital
ClinicalTrials.gov Identifier: NCT01300117     History of Changes
Other Study ID Numbers: TTP-KC
Study First Received: February 18, 2011
Last Updated: December 28, 2011
Health Authority: Germany: Ethics Commission

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

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

ClinicalTrials.gov processed this record on October 20, 2014