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NCT01300117 Clinical Trial

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

Cardiac Surgery Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01300117
Other study ID # TTP-KC
Secondary ID
Status Recruiting
Phase N/A
First received February 18, 2011
Last updated December 28, 2011
Start date October 2010

Study information
Verified date December 2011
Source Johann Wolfgang Goethe University Hospitals
Contact Wolfgang Miesbach
Phone +49696301
Email wolfgang.miesbach@kgu.de
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 70
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Johann Wolfgang Goethe University Hospital Frankfurt Hessen

Sponsors (1)
Lead Sponsor Collaborator
Johann Wolfgang Goethe University Hospitals

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in ADAMTS13-Activity over time during surgery (at 1and 2 hours after beginning) and within the first 6 days after surgery No
Secondary Change in ADAMTS13-Antibody over time during surgery (at 1and 2 hours after beginning) and within the first 6 days after surgery No
Secondary Change in Platelet count over time during surgery (at 1and 2 hours after beginning) and within the first 6 days after surgery No
Secondary time duration of extracorporeal circulation during surgery during surgery No
Secondary Amount of intraoperative given fluid replacement during surgery No
Secondary Amount of given blood products (red blood cells) 24 hours No
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