| September 8, 2005 |
| September 17, 2009 |
| October 2004 |
| July 2010 (final data collection date for 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 ] |
| 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 |
| Complete list of historical versions of study NCT00157677 on ClinicalTrials.gov Archive Site |
- 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 ]
|
- bleeding
- healthcare utilization
- cost-effectiveness
|
| |
| Selective D-Dimer Testing Compared With Uniform D-Dimer Testing in the Diagnosis of Deep Vein Thrombosis (SELECT) |
| Selective D-Dimer Testing Compared With Uniform D-Dimer Testing in the Diagnosis of Deep Vein Thrombosis: A Randomized Trial |
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. |
- Limiting use of D-dimer testing to outpatients with a Low or Moderate clinical pretest probability (C-PTP)for deep vein thrombosis AND using a D-dimer level of < 1.0 µg FEU/mL to exclude deep vein thrombosis in those with a Low C-PTP, and a D-dimer level of < 0.5 µg FEU/mL to exclude deep vein thrombosis in those with a Moderate C-PTP, is as safe and a more efficient way to diagnose DVT than:
- Performing D-dimer testing in all patients with suspected deep vein thrombosis with use of a single D-dimer value of < 0.5 µg FEU/mL to exclude thrombosis (current practice).
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. |
| Phase III |
| Interventional |
| Diagnostic, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
| Deep Vein Thrombosis |
| Procedure: D-dimer testing |
- Experimental: Selective D-Dimer use
- Active Comparator: Uniform D-Dimer use
|
| |
| |
| Recruiting |
| 2000 |
| July 2010 |
| July 2010 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Age 18 and older
- Presenting with symptoms compatible with clinically suspected deep vein thrombosis
Exclusion Criteria:
- Treatment with full dose anticoagulation for 24 hours or more.
- Other test for deep vein thrombosis already performed.
- Ongoing need for therapeutic anticoagulant therapy.
- Life expectancy less than 3 months.
- Absence of acute symptoms within 7 days of presentation.
- Presenting with symptoms of pulmonary embolism.
- Previous confirmed episode of deep vein thrombosis or pulmonary embolism.
- Current pregnancy.
- Geographic inaccessibility which precludes follow-up.
|
| Both |
| 18 Years and older |
| No |
|
|
| Canada |
| |
| NCT00157677 |
| Lori Linkins, MD, McMaster University |
| CTMG-2005-SELECT, Grant Number: NA 5429 |
| McMaster University |
| Heart and Stroke Foundation of Ontario |
| Principal Investigator: |
Lori Linkins, MD |
McMaster University |
|
| Principal Investigator: |
Clive Kearon, MD |
McMaster University |
|
| Principal Investigator: |
Jim Julian, MMath |
McMaster University, Dept. of Clinical Epidemiology and Biostatistics |
|
|
| McMaster University |
| September 2009 |