Recruitment

Recruitment Status
Terminated
Estimated Enrollment
25

Inclusion Criteria

Patient is < 80 years old.
The study population tested will be recruited from ambulatory outpatients (presenting at the emergency unit or outpatient clinic) suspected of having DVT.
Patient presenting at least one of these symptoms indicative of proximal DVT: leg pain, tenderness (discomfort through palpation), leg swelling and /or edema,
...
Patient is < 80 years old.
The study population tested will be recruited from ambulatory outpatients (presenting at the emergency unit or outpatient clinic) suspected of having DVT.
Patient presenting at least one of these symptoms indicative of proximal DVT: leg pain, tenderness (discomfort through palpation), leg swelling and /or edema,
Patient provides written informed consent to participate in the sample collection
Patient has confirmed proximal DVT by imaging
Low or moderate Wells score

Exclusion Criteria

Pregnancy or post-partum within the previous 1 month,
Patients presenting with a suspect thrombotic event related to catheter implantation
Deep hematoma diagnosed by imaging techniques within the previous one (1) month,
...
Pregnancy or post-partum within the previous 1 month,
Patients presenting with a suspect thrombotic event related to catheter implantation
Deep hematoma diagnosed by imaging techniques within the previous one (1) month,
Known liver cirrhosis,
Fibrinolytic therapy within the previous seven (7) days,
Sickle cell disease,
Bone fracture or surgery (with general anesthesia longer than thirty (30) minutes) within the previous one (1) month,
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),
Atherosclerotic vascular disease thrombosis within the previous 1month (e.g. myocardial infarction, stroke, coronary syndrome, peripheral artery disease stage III or IV),
Ongoing therapeutic anticoagulants (curative and preventive treatment) starting twenty four (24) hours or more before the blood drawing for D-dimer testing
Sepsis, severe infections, pneumonia within the previous 1 month,

Summary

Conditions
Deep Venous Thrombosis
Type
Observational
Design
  • Observational Model: Case-Only
  • Time Perspective: Prospective

Participation Requirements

Age
Younger than 80 years
Gender
Both males and females

Inclusion Criteria

Patient is < 80 years old.
The study population tested will be recruited from ambulatory outpatients (presenting at the emergency unit or outpatient clinic) suspected of having DVT.
Patient presenting at least one of these symptoms indicative of proximal DVT: leg pain, tenderness (discomfort through palpation), leg swelling and /or edema,
...
Patient is < 80 years old.
The study population tested will be recruited from ambulatory outpatients (presenting at the emergency unit or outpatient clinic) suspected of having DVT.
Patient presenting at least one of these symptoms indicative of proximal DVT: leg pain, tenderness (discomfort through palpation), leg swelling and /or edema,
Patient provides written informed consent to participate in the sample collection
Patient has confirmed proximal DVT by imaging
Low or moderate Wells score

Exclusion Criteria

Pregnancy or post-partum within the previous 1 month,
Patients presenting with a suspect thrombotic event related to catheter implantation
Deep hematoma diagnosed by imaging techniques within the previous one (1) month,
...
Pregnancy or post-partum within the previous 1 month,
Patients presenting with a suspect thrombotic event related to catheter implantation
Deep hematoma diagnosed by imaging techniques within the previous one (1) month,
Known liver cirrhosis,
Fibrinolytic therapy within the previous seven (7) days,
Sickle cell disease,
Bone fracture or surgery (with general anesthesia longer than thirty (30) minutes) within the previous one (1) month,
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),
Atherosclerotic vascular disease thrombosis within the previous 1month (e.g. myocardial infarction, stroke, coronary syndrome, peripheral artery disease stage III or IV),
Ongoing therapeutic anticoagulants (curative and preventive treatment) starting twenty four (24) hours or more before the blood drawing for D-dimer testing
Sepsis, severe infections, pneumonia within the previous 1 month,

Tracking Information

NCT #
NCT02078154
Collaborators
Not Provided
Investigators
  • Principal Investigator: Suman Wasan Rathbun, MD University of Oklahoma Health Sciences
  • Suman Wasan Rathbun, MD University of Oklahoma Health Sciences
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