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 @ 4:59 AM
Ignite Modification Date:
2025-12-25 @ 4:59 AM
NCT ID:
NCT02719418
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years old
* A prescription of prophylactic tinzaparin (3500 IU or 4500 IU) has been initiated by order of the treating physician
* Patient admitted for medical reasons by one (but not limited to) of the following wards: nephrology, internal medicine, cardiology or pneumology
* Chronic severe renal impairment defined as an eGFR ≤ 30 mL/min/1.73 m2 at the moment of prescription and when available, eGFR at baseline, ie ≤ 30 ml/min/1.73 m2 for the last 3 months
* Estimated length of stay ≥ 5 days
* Written informed consent obtained within at most 3 ± 1 hours after the second or third dose of tinzaparin.
Exclusion Criteria:
* Super obese (Body-mass Index (BMI) \> 50kg/m2)
* Treatment with UFH, LMWH or oral factor Xa inhibitors \<48h prior starting the first dose of tinzaparin
* Prophylaxis with LMWH other than tinzaparin \< 48h prior starting the first dose of tinzaparin
* Prophylaxis with heparin \< 12h prior starting the first dose of tinzaparin
* Treatment with argatroban, bivalirudin \< 24 hours prior starting the first dose of tinzaparin
* Treatment with oral direct thrombin inhibitors, danaparoid, fondaparinux, or anti-vitamin K agents for \< 7 days prior to starting the first dose of tinzaparin
* Acute renal failure in an individual with baseline eGFR \> 30 ml/min/1.73 m2
* Prophylactic tinzaparin in use for more than 72h before inclusion
* Severe liver insufficiency (Child- Pugh C)
* Anuria or chronically dialysed patients (or eGFR \< 5 ml/min/1.73 m2)
* Participation in another study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02719418
Study Brief:
Protocol Section:
NCT02719418