Measurement of D-Dimer Levels in Patients With Confirmed Deep Vein Thrombosis

Deep Venous Thrombosis Clinical Trial

Official title:

Measurement of D-Dimer Levels in Patients With Confirmed Deep Vein Thrombosis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02078154
• Other study ID #: D-Dimer DVT
• Status: Terminated
• Phase: N/A
• First received: February 26, 2014
• Last updated: June 2, 2015
• Start date: April 2014
• Est. completion date: January 2015

Study information

• Verified date: June 2015
• Source: Diagnostica Stago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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,

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 80 Years

Eligibility

Inclusion Criteria:

• The study population tested will be recruited from ambulatory outpatients (presenting at the emergency unit or outpatient clinic) suspected of having DVT.

• Patient is < 80 years old.

• Patient presenting at least one of these symptoms indicative of proximal DVT: leg pain, tenderness (discomfort through palpation), leg swelling and /or edema,

• Patient has confirmed proximal DVT by imaging

• Low or moderate Wells score

• Patient provides written informed consent to participate in the sample collection

Exclusion Criteria:

• Patient presenting with a condition that may be associated with increased D-dimer levels, even in the absence of VTE, such as:

1. Fibrinolytic therapy within the previous seven (7) days,

2. Bone fracture or surgery (with general anesthesia longer than thirty (30) minutes) within the previous one (1) month,

3. Deep hematoma diagnosed by imaging techniques within the previous one (1) month,

4. Disseminated malignancies and active cancer (active cancer defined as: cancer for which therapeutic or palliative treatment is either ongoing at the time of enrolment or has stopped less than six (6) months before enrolment),

5. Sepsis, severe infections, pneumonia within the previous 1 month,

6. Known liver cirrhosis,

7. Pregnancy or post-partum within the previous 1 month,

8. Atherosclerotic vascular disease thrombosis within the previous 1month (e.g. myocardial infarction, stroke, coronary syndrome, peripheral artery disease stage III or IV),

9. Sickle cell disease,

• 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Deep Venous Thrombosis
• Thrombosis
• Venous Thrombosis

Locations

Country	Name	City	State
United States	The University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Diagnostica Stago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	At the initial visit (up to 24 hours)	No
Primary	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)	No
Secondary	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	At the initial visit (up to 24 hours)	No