Safety Study of Stopping Thromboprophylaxis Based on Ultrasound Results After Total Knee Replacement
This study has been completed.
Sponsor:
University Hospital, Caen
Information provided by:
University Hospital, Caen
ClinicalTrials.gov Identifier:
NCT00362492
First received: August 9, 2006
Last updated: October 27, 2010
Last verified: October 2010
| Tracking Information | |||||||||
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| First Received Date ICMJE | August 9, 2006 | ||||||||
| Last Updated Date | October 27, 2010 | ||||||||
| Start Date ICMJE | June 2004 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00362492 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Current Other Outcome Measures ICMJE | |||||||||
| Original Other Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Safety Study of Stopping Thromboprophylaxis Based on Ultrasound Results After Total Knee Replacement | ||||||||
| Official Title ICMJE | 9-10 Days Versus Prolonged Thromboprophylaxis in Patients Without Evidence of Ultrasound Proximal Thromboembolism After Total Knee Joint Replacement: a Randomized Controlled Trial | ||||||||
| Brief Summary | The purpose of this study is to determine whether stopping Low Molecular Weight Heparin (LMWH) thromboprophylaxis is safe after total knee joint replacement. The investigators select patients without proximal thromboembolism assessed by bilateral venous ultrasound examination 7-10 days after surgery. the investigators hypothesis is that stopping thromboprophylaxis is equally effective than prolonging thromboprophylaxis in order to prevent post-surgery complications in this population. |
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| Detailed Description | |||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 4 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE | Procedure: Bilateral ultrasound examination 7+/- 2 after surgery | ||||||||
| Study Arm (s) | |||||||||
| Publications * | Barrellier MT, Lebel B, Parienti JJ, Mismetti P, Dutheil JJ, Vielpeau C; PROTHEGE study group; GETHCAM study group. Short versus extended thromboprophylaxis after total knee arthroplasty: a randomized comparison. Thromb Res. 2010 Oct;126(4):e298-304. Epub 2010 Aug 24. | ||||||||
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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 | Completed | ||||||||
| Estimated Enrollment ICMJE | 850 | ||||||||
| Completion Date | June 2007 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Non-inclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 46 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | France | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00362492 | ||||||||
| Other Study ID Numbers ICMJE | PHRC-Prothege | ||||||||
| Has Data Monitoring Committee | |||||||||
| Responsible Party | |||||||||
| Study Sponsor ICMJE | University Hospital, Caen | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | University Hospital, Caen | ||||||||
| Verification Date | October 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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