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

NCT ID: NCT01102790

Last Updated: 2010-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-04-30

Study Completion Date

2010-10-31

Brief Summary

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

Detailed Description

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Conditions

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Heparin-Induced Thrombocytopenia Thrombosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Major orthopedic surgery

Exclusion Criteria

* Heparin exposure
* Infection
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johann Wolfgang Goethe University Hospital

OTHER

Sponsor Role lead

Responsible Party

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J.W.Goethe University Hospital, Department of Internal Medicine, Division of Vascular Medicine

Principal Investigators

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Marc Schindewolf, MD

Role: PRINCIPAL_INVESTIGATOR

J.W. Goethe University-Hospital Frankfurt/M.

Edelgard Lindhoff-Last, Prof.

Role: PRINCIPAL_INVESTIGATOR

J.W. Goethe-University Hospital Frankfurt/M.

Locations

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J.W.Goethe University Hospital Frankfurt/M.

Frankfurt am Main, Hesse, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Marc Schindewolf, MD

Role: CONTACT

+49 (0)69-6301 ext. 5096

Edelgard Lindhoff-Last, Prof.

Role: CONTACT

+49 (0)69-6301 ext. 5096

Facility Contacts

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Marc Schindewolf, MD

Role: primary

+49 (0)69-6301 ext. 5096

Edelgard Lindhoff-Last, Prof.

Role: backup

+49 (0)69-6301 ext. 5096

References

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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.

Reference Type BACKGROUND
PMID: 18612559 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18589060 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18513213 (View on PubMed)

Other Identifiers

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243/09

Identifier Type: -

Identifier Source: org_study_id

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