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| Descriptive Information Fields | |||||||||||||
| Brief Title † | Selective D-Dimer Testing Compared With Uniform D-Dimer Testing in the Diagnosis of Deep Vein Thrombosis (SELECT) | ||||||||||||
| Official Title † | Selective D-Dimer Testing Compared With Uniform D-Dimer Testing in the Diagnosis of Deep Vein Thrombosis: A Randomized Trial | ||||||||||||
| Brief Summary | The purpose of this study is to compare two diagnostic interventions to improve the way D-dimer blood testing (MDA D-dimer) is used to diagnose first time symptomatic deep vein thrombosis. |
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| Detailed Description |
All randomized patients, including those who are treated for deep vein thrombosis after initial testing, will be followed for a period of 3 months to monitor for signs and symptoms suggestive of deep vein thrombosis, pulmonary embolism, bleeds and death. |
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| Study Phase | Phase III | ||||||||||||
| Study Type † | Interventional | ||||||||||||
| Study Design † | Diagnostic, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study | ||||||||||||
| Primary Outcome Measure † | objectively confirmed proximal deep vein thrombosis or pulmonary embolism during 3 months of follow-up in patients who are not diagnosed with deep vein thrombosis during diagnostic testing and are not anticoagulated [ Time Frame: 3 Months ] [ Designated as safety issue: Yes ] | ||||||||||||
| Secondary Outcome Measure † | bleeding [ Time Frame: 3 Months ] [ Designated as safety issue: Yes ] healthcare utilization [ Time Frame: 3 Months ] [ Designated as safety issue: No ] cost-effectiveness [ Time Frame: 3 Months ] [ Designated as safety issue: No ] |
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| Condition † | Deep Vein Thrombosis | ||||||||||||
| Intervention † | Procedure: D-dimer testing | ||||||||||||
| MEDLINE PMIDs | |||||||||||||
| Links | |||||||||||||
| Recruitment Information Fields | |||||||||||||
| Recruitment Status † | Recruiting | ||||||||||||
| Enrollment † | 2000 | ||||||||||||
| Start Date † | October 2004 | ||||||||||||
| Completion Date | June 2009 | ||||||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||
| Ages | 18 Years and older | ||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||
| Contacts †† |
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| Location Countries † | Canada | ||||||||||||
| Administrative Information Fields | |||||||||||||
| NCT ID † | NCT00157677 | ||||||||||||
| Organization ID | CTMG-2005-SELECT | ||||||||||||
| Secondary IDs †† | Grant Number: NA 5429 | ||||||||||||
| Study Sponsor † | McMaster University | ||||||||||||
| Collaborators †† | Heart and Stroke Foundation of Ontario | ||||||||||||
| Investigators † |
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| Information Provided By | McMaster University | ||||||||||||
| Verification Date | December 2008 | ||||||||||||
| First Received Date † | September 8, 2005 | ||||||||||||
| Last Updated Date | December 2, 2008 | ||||||||||||