Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-24 @ 9:34 PM
NCT ID:
NCT02767232
Eligibility Criteria:
Inclusion Criteria:
* Subject and/or legal guardian has voluntarily provided signed informed consent.
* Subject is 6-21 years old with a minimum weight of 20 kg at the time of enrollment.
* Radiologically-confirmed, symptomatic proximal lower extremity DVT involving the inferior vena cava, iliac vein, and/or common femoral vein; DVT must be occlusive in at least one involved vein
* Life expectancy greater than or equal to 2 years.
Exclusion Criteria:
* Symptom duration \> 14 days for DVT episode in affected leg
* Known history of a bleeding disorder
* Known history of heparin-induced thrombocytopenia (HIT)
* Prior established diagnosis of PTS in lower extremities
* Circulatory compromise necessitating surgery
* Pulmonary embolism with hemodynamic compromise or other acute illness precluding tolerance of catheter-directed therapy
* Severe hypersensitivity or allergy to Activase(R), iodinated contrast or planned treatment anticoagulant drug, except for mild-moderate contrast allergies for which steroid pre-treatment can be used.
* Inability to maintain hemoglobin \<9.0 mg/dL, INR \>1.7, or platelets \<100,000/mL, using transfusion as indicated.
* Active or historic bleeding, vasculopathy, coagulopathy, invasive procedure or medical condition contraindicating thrombolysis or anticoagulation
* Previous thrombolysis within the last month
* Pregnant female or within 7 days of uncomplicated delivery
* Participation in another investigational study within the last month
* Life expectancy \< 2 years or with chronic non-ambulatory status
* Inability to provide informed consent or to comply with study assessments
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
21 Years
Study:
NCT02767232
Study Brief:
Protocol Section:
NCT02767232