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:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 1:22 AM
NCT ID:
NCT00265993
Eligibility Criteria:
Inclusion Criteria:
* Patients with symptomatic lower-extremity deep venous thrombosis confirmed by doppler USG (ultrasonography), with or without confirmed symptomatic pulmonary embolism associated with provoked risk factors
Exclusion Criteria:
* Patients with a history of heparin or warfarin treatment longer than 24 hours,
* Patients requiring thrombolytic treatment,
* Patients having thrombophilia diagnosis,
* Patients with prior deep vein thrombosis or pulmonary emboli evidence,
* Patients with familial bleeding disorder,
* Patients who are at any known bleeding risk, such as active bleeding, active ulcerative bowel disease, angiodysplasia and having oculary, spinal or central nervous system surgery within the last month
* Patients with renal failure (serum creatinine concentration \> 180 mmol/L or \> 2.03 mg/dL),
* Patients with severe hepatic failure
* Patients with history of allergy against heparin and protamine,
* Patients with history of thrombocytopenia associated with heparin administration or of skin necrosis after heparin or warfarin treatment,
* Patients participating in another clinical study within the last 4 months
* Patients who are pregnant
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00265993
Study Brief:
Protocol Section:
NCT00265993