Generation of Heparin-induced Thrombocytopenia (HIT)-Antibodies Without Prior Heparin Exposure
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Johann Wolfgang Goethe University Hospitals.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Johann Wolfgang Goethe University Hospitals
Information provided by:
Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT01102790
First received: April 7, 2010
Last updated: April 14, 2010
Last verified: April 2010
| Tracking Information | |||||||||
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| First Received Date ICMJE | April 7, 2010 | ||||||||
| Last Updated Date | April 14, 2010 | ||||||||
| Start Date ICMJE | April 2010 | ||||||||
| Estimated Primary Completion Date | September 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
incidence of HIT-antibodies [ Time Frame: between day 5 and day 14 after surgery ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01102790 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
thromboembolic events [ Time Frame: up to 21 days after surgery ] [ Designated as safety issue: Yes ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Generation of Heparin-induced Thrombocytopenia (HIT)-Antibodies Without Prior Heparin Exposure | ||||||||
| Official Title ICMJE | 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]) | ||||||||
| Brief Summary | The purpose of this study is to determine the HIT-antibody generation without prior heparin-exposure in patients undergoing orthopedic surgery. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description: serum citrated blood edta blood |
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| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Patients in a primary care clinic undergoing orthopedic surgery without heparin exposure |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 160 | ||||||||
| Estimated Completion Date | October 2010 | ||||||||
| Estimated Primary Completion Date | September 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Germany | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01102790 | ||||||||
| Other Study ID Numbers ICMJE | 243/09 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Edelgard Lindhoff-Last, Professor, J.W.Goethe University Hospital, Department of Internal Medicine, Division of Vascular Medicine | ||||||||
| Study Sponsor ICMJE | Johann Wolfgang Goethe University Hospitals | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Johann Wolfgang Goethe University Hospitals | ||||||||
| Verification Date | April 2010 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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