Influence of Extracorporeal Circulation During Cardiac Surgery on the Development of Postoperative Thrombotic Thrombocytopenic Purpura (TTP)
Sponsor
Johann Wolfgang Goethe University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01300117
Collaborator
(none)
70
1
Study Details
Study Description
Brief Summary
The purpose of this study is to determine whether extracorporeal circulation during cardiac surgery has an influence on ADAMTS13-Activity.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
70 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Influence of Extracorporeal Circulation During Cardiac Surgery on the Development of Postoperative TTP
Study Start Date
:
Oct 1, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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) |
Outcome Measures
Primary Outcome Measures
- Change in ADAMTS13-Activity over time [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 [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]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Johann Wolfgang Goethe University Hospital | Frankfurt | Hessen | Germany | 60590 |
Sponsors and Collaborators
- Johann Wolfgang Goethe University Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT01300117
Other Study ID Numbers:
- TTP-KC
First Posted:
Feb 21, 2011
Last Update Posted:
Dec 29, 2011
Last Verified:
Dec 1, 2011