- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01102790
Generation of Heparin-induced Thrombocytopenia (HIT)-Antibodies Without Prior Heparin Exposure
April 14, 2010 updated by: Johann Wolfgang Goethe University Hospital
Generation of HIT-antibodies Without Prior Heparin Exposure Following Orthopedic Surgery (Subgroup Study) (Change of Coagulation Parameters Under Exposition With New Anticoagulants [Title of the Main Study])
The purpose of this study is to determine the HIT-antibody generation without prior heparin-exposure in patients undergoing orthopedic surgery.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
160
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Marc Schindewolf, MD
- Phone Number: 5096 +49 (0)69-6301
- Email: marcschindewolf@yahoo.com
Study Contact Backup
- Name: Edelgard Lindhoff-Last, Prof.
- Phone Number: 5096 +49 (0)69-6301
- Email: Lindhoff-Last@em.uni-frankfurt.de
Study Locations
-
-
Hessen
-
Frankfurt am Main, Hessen, Germany, 60590
- Recruiting
- J.W.Goethe University Hospital Frankfurt/M.
-
Contact:
- Marc Schindewolf, MD
- Phone Number: 5096 +49 (0)69-6301
- Email: marcschindewolf@yahoo.com
-
Contact:
- Edelgard Lindhoff-Last, Prof.
- Phone Number: 5096 +49 (0)69-6301
- Email: Lindhoff-Last@em.uni-frankfurt.de
-
Principal Investigator:
- Edelgard Lindhoff-Last, Prof.
-
Principal Investigator:
- Marc Schindewolf, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients in a primary care clinic undergoing orthopedic surgery without heparin exposure
Description
Inclusion Criteria:
- Major orthopedic surgery
Exclusion Criteria:
- Heparin exposure
- Infection
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
incidence of HIT-antibodies
Time Frame: between day 5 and day 14 after surgery
|
between day 5 and day 14 after surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
thromboembolic events
Time Frame: up to 21 days after surgery
|
up to 21 days after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Marc Schindewolf, MD, J.W. Goethe University-Hospital Frankfurt/M.
- Principal Investigator: Edelgard Lindhoff-Last, Prof., J.W. Goethe-University Hospital Frankfurt/M.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Schindewolf M, Lindhoff-Last E. Fondaparinux-related thrombocytopenia in a patient with former HIT. Response to Rota et al. (Thromb Haemost 2008; 99: 779-781). Thromb Haemost. 2008 Jul;100(1):168-9; author reply 169-70. doi: 10.1160/TH08-04-0222. No abstract available.
- Warkentin TE, Makris M, Jay RM, Kelton JG. A spontaneous prothrombotic disorder resembling heparin-induced thrombocytopenia. Am J Med. 2008 Jul;121(7):632-6. doi: 10.1016/j.amjmed.2008.03.012.
- Jay RM, Warkentin TE. Fatal heparin-induced thrombocytopenia (HIT) during warfarin thromboprophylaxis following orthopedic surgery: another example of 'spontaneous' HIT? J Thromb Haemost. 2008 Sep;6(9):1598-600. doi: 10.1111/j.1538-7836.2008.03040.x. Epub 2008 May 29. No abstract available.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2010
Primary Completion (Anticipated)
September 1, 2010
Study Completion (Anticipated)
October 1, 2010
Study Registration Dates
First Submitted
April 7, 2010
First Submitted That Met QC Criteria
April 12, 2010
First Posted (Estimate)
April 13, 2010
Study Record Updates
Last Update Posted (Estimate)
April 15, 2010
Last Update Submitted That Met QC Criteria
April 14, 2010
Last Verified
April 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 243/09
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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