Generation of Heparin-induced Thrombocytopenia (HIT)-Antibodies Without Prior Heparin Exposure
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])
1 other identifier
observational
160
1 country
1
Brief Summary
The purpose of this study is to determine the HIT-antibody generation without prior heparin-exposure in patients undergoing orthopedic surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2010
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 7, 2010
CompletedFirst Posted
Study publicly available on registry
April 13, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedApril 15, 2010
April 1, 2010
5 months
April 7, 2010
April 14, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
incidence of HIT-antibodies
between day 5 and day 14 after surgery
Secondary Outcomes (1)
thromboembolic events
up to 21 days after surgery
Eligibility Criteria
Patients in a primary care clinic undergoing orthopedic surgery without heparin exposure
You may qualify if:
- Major orthopedic surgery
You may not qualify if:
- Heparin exposure
- Infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
J.W.Goethe University Hospital Frankfurt/M.
Frankfurt am Main, Hesse, 60590, Germany
Related Publications (3)
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.
PMID: 18612559BACKGROUNDWarkentin 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.
PMID: 18589060BACKGROUNDJay 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.
PMID: 18513213BACKGROUND
Biospecimen
serum citrated blood edta blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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.
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 7, 2010
First Posted
April 13, 2010
Study Start
April 1, 2010
Primary Completion
September 1, 2010
Study Completion
October 1, 2010
Last Updated
April 15, 2010
Record last verified: 2010-04