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Decision to start a new study on DVT with another protocol
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Measurement of D-Di (D-Dimer) levels using the in-vitro diagnostic reagent STA® - Liatest® D-Di and STA® - Liatest® D-Di PLUS in plasma samples from patients diagnosed with Deep Vein Thrombosis (DVT) Data from this study may be used in conjunction with data from the prospective study entitled "STA® - Liatest® D-Di - Exclusion of Venous Thromboembolism (VTE)", NCT01221805, the DiET study,
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deep Venous Thrombosis (DVT) | DVT diagnosed by imaging technique with a low or moderate Wells score |
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| Measure | Description | Time Frame |
|---|---|---|
| STA Liatest DDi results in DVT positive cases | Prospective, ambulatory outpatients (presenting to the emergency unit or outpatient clinic) suspected of having DVT, with a proximal positive imaging results, will be screened for eligibility using the inclusion and exclusion criteria (see Section above). Then the eligible patients will be evaluated using the Wells score and only patient with Low or moderate Pre-Test Probability (PTP) will receive full explanation concerning nature, objectives and risks associated to the participation in this study. Written informed consent will be obtained from each participating subject prior blood drawing, processing, plasma aliquoting and freezing at -80°C for D-Dimer testing (STA Liatest DDi). The whole process, starting from the moment the patient is diagnosed with DVT, should not exceed 24 hours. | At the initial visit (up to 24 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| STA Liatest DDi Versus STA Liatest DDi Plus | Prospective, ambulatory outpatients (presenting to the emergency unit or outpatient clinic) suspected of having DVT, with a proximal positive imaging results, will be screened for eligibility using the inclusion and exclusion criteria (see Section above). Then the eligible patients will be evaluated using the Wells score and only patient with Low or moderate PTP will receive full explanation concerning nature, objectives and risks associated to the participation in this study. Written informed consent will be obtained from each participating subject prior blood drawing, processing, plasma aliquoting and freezing at -80°C for D-Dimer testing (STA Liatest DDi Plus). The whole process, starting from the moment the patient is diagnosed with DVT, should not exceed 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma bank for DDi measurements | Prospective, ambulatory outpatients (presenting to the emergency unit or outpatient clinic) suspected of having DVT, with a proximal positive imaging results, will be screened for eligibility using the inclusion and exclusion criteria (see Section above). Then the eligible patients will be evaluated using the Wells score and only patient with Low or moderate PTP will receive full explanation concerning nature, objectives and risks associated to the participation in this study. Written informed consent will be obtained from each participating subject prior blood drawing, processing, plasma aliquoting and freezing at -80°C for D-Dimer testing (STA Liatest DDi or STA Liatest DDi Plus to investigate unmatched results). The whole process, starting from the moment the patient is diagnosed with DVT, should not exceed 24 hours |
Inclusion Criteria:
Exclusion Criteria:
Patient presenting with a condition that may be associated with increased D-dimer levels, even in the absence of VTE, such as:
Patients presenting with a suspect thrombotic event related to catheter implantation
Ongoing therapeutic anticoagulants (curative and preventive treatment) starting twenty four (24) hours or more before the blood drawing for D-dimer testing
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Patients with proximal DVT diagnosed by imaging technique and with a low and moderate Wells score
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| Name | Affiliation | Role |
|---|---|---|
| Suman Wasan Rathbun, MD | University of Oklahoma Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
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| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Plasma samples
| At the initial visit (up to 24 hours) |
| At the initial visit (up to 24 hours) |