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 @ 1:15 PM
Ignite Modification Date:
2025-12-24 @ 1:15 PM
NCT ID:
NCT00954395
Eligibility Criteria:
Inclusion Criteria:
Age \> 18 years first episode of objectively documented symptomatic idiopathic VTE, either proximal lower extremity deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
Unprovoked or idiopathic , or associated with one or more of the following favouring factors
ยท - minor general surgery, arthroscopy or laparoscopy
* pregnancy or puerperium
* hormonal treatment (contraceptive or replacement therapy)
* travel
* minor traumas
* hospitalization in a medical ward
* reduced mobility (non complete immobilization) at least six months of VKA therapy ( or other type) for at least 3 months and not longer than 12 months ability to provide informed consent
Exclusion criteria:
* Two or more episodes of objectively documented proximal DVT and or PE ( previous distal of superficial vein thrombosis are not exclusion criteria)
* Index event was isolate distal ( calf) vein thrombosis
* Index event was PE associated with shock or prolonged hypotension at high risk
* Index event was DVT in sites different from the lower limbs
* Pregnancy or puerperium ( first 6 weeks after delivery) at the time of the visit
* Solid or haematological malignancy in the active phase or undergoing chemotherapy or radiotherapy
* Antiphospholipid antibody syndrome, diagnosed according to the Sydney criteria
* Hereditary antithrombin deficiency
* Necessity to prolong anticoagulation for any reason (due to the thrombotic event or other clinical indications
* Severe respiratory or heart failure (NYHA classes: III or IV)
* Presence of criteria indicating a short anticoagulant treatment:
Venous thromboembolism secondary to one of the following triggering factors:
* Major surgery \[orthopedic, general, oncological (only if radical)\]
* Bed rest (\>4 dd)
* Severe trauma
* Plaster cast of the lower limbs
* high bleeding risk
* limited life expectancy,
* geographical inaccessibility
* Inability or refusal to provide informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00954395
Study Brief:
Protocol Section:
NCT00954395