Recruitment

Recruitment Status
Terminated
Estimated Enrollment
25

Inclusion Criterias

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
Low or moderate Wells score
...
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
Low or moderate Wells score
Patient has confirmed proximal DVT by imaging
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.

Exclusion Criterias

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

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 Criterias

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
Low or moderate Wells score
...
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
Low or moderate Wells score
Patient has confirmed proximal DVT by imaging
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.

Exclusion Criterias

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

Locations

Oklahoma City, Oklahoma, 73104
Oklahoma City, Oklahoma, 73104

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