Influence of Extracorporeal Circulation During Cardiac Surgery on the Development of Postoperative Thrombotic Thrombocytopenic Purpura (TTP)
1 other identifier
observational
70
1 country
1
Brief Summary
The purpose of this study is to determine whether extracorporeal circulation during cardiac surgery has an influence on ADAMTS13-Activity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 18, 2011
CompletedFirst Posted
Study publicly available on registry
February 21, 2011
CompletedDecember 29, 2011
December 1, 2011
February 18, 2011
December 28, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in ADAMTS13-Activity over time
during surgery (at 1and 2 hours after beginning) and within the first 6 days after surgery
Secondary Outcomes (5)
Change in ADAMTS13-Antibody over time
during surgery (at 1and 2 hours after beginning) and within the first 6 days after surgery
Change in Platelet count over time
during surgery (at 1and 2 hours after beginning) and within the first 6 days after surgery
time duration of extracorporeal circulation during surgery
during surgery
Amount of intraoperative given fluid replacement
during surgery
Amount of given blood products (red blood cells)
24 hours
Study Arms (2)
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 Criteria
Patients undergoing cardiac surgery at the University Hospital
You may qualify if:
- cardiac surgery with or without (OPCAB) the use of extracorporeal circulation
- patient agrees
You may not qualify if:
- no agreement
- known TTP in medical history
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Johann Wolfgang Goethe University Hospital
Frankfurt am Main, Hesse, 60590, Germany
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 18, 2011
First Posted
February 21, 2011
Study Start
October 1, 2010
Last Updated
December 29, 2011
Record last verified: 2011-12