Generation of Heparin-induced Thrombocytopenia (HIT)-Antibodies Without Prior Heparin Exposure

Thrombosis Clinical Trial

Official title:

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])

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01102790
• Other study ID #: 243/09
• Status: Recruiting
• Phase: N/A
• First received: April 7, 2010
• Last updated: April 14, 2010
• Start date: April 2010
• Est. completion date: October 2010

Study information

• Verified date: April 2010
• Source: Johann Wolfgang Goethe University Hospitals
• Contact: Marc Schindewolf, MD
• Phone: +49 (0)69-6301
• Email: marcschindewolf[@]yahoo.com
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine the HIT-antibody generation without prior heparin-exposure in patients undergoing orthopedic surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: October 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Major orthopedic surgery

Exclusion Criteria:

• Heparin exposure

• Infection

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heparin-Induced Thrombocytopenia
• Thrombocytopenia
• Thrombocytosis
• Thrombosis

Locations

Country	Name	City	State
Germany	J.W.Goethe University Hospital Frankfurt/M.	Frankfurt am Main	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospitals

Country where clinical trial is conducted

Germany, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of HIT-antibodies		between day 5 and day 14 after surgery	Yes
Secondary	thromboembolic events		up to 21 days after surgery	Yes