At a glance
ClinicalIndex Comparison Record- ✓Rigid or semi-rigid immobilization for 21-45 days due to isolated non-surgical below-knee injury
- ✓No weight-bearing recommendation at inclusion (partial weight bearing permitted)
- ✓At least one VTE risk factor: below-knee fracture, Achilles tendon rupture, age ≥40, BMI >30, estrogen-containing hormone therapy or oral contraception, active cancer (ongoing or stopped <1 year), history of VTE, congenital or acquired hypercoagulable state
- ✓Thromboprophylaxis required per investigator judgment through complete mobilization
- ✕Injury to randomization interval >2 days
- ✕Prior antithrombotic or anticoagulant therapy for >2 days before randomization
- ✕Anticoagulation required or likely required during study for other indication (planned surgery, curative VTE treatment)
- ✕Known hypersensitivity to fondaparinux, nadroparin, or their excipients
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicentre, Randomized, Open-label Study to Evaluate the Efficacy andSafety of Fondaparinux Versus Low Molecular Weight Heparin(Nadroparin) in Patients Requiring Rigid or Semi-rigid Immobilization for at Least 21 Days and up to 45 Days Because of Isolated Non-surgical Below-Knee Injury
In Brief
A Phase 3 clinical trial evaluating Fondaparinux sodium and Nadroparin for Thrombosis, Venous. Completed, enrolled 1,351 participants across 122 sites in 6 countries.
Detailed Summary
The purpose of this study is to evaluate the efficacy and safety of fondaparinux in comparison with a heparin (nadroparin) in preventing deep vein thrombosis (blood clots in the leg veins), whether symptomatic or detected by ultrasound, and pulmonary embolism (blood clots that migrate to the lungs) in patients with leg injuries below the knee that require a cast or other type of immobilization but not surgery.
Study Details
Timeline
Interventions
After randomization (Day 1), subjects will receive subcutaneously once daily fondaparinux 2.5 mg \[0.5mL\] (1.5 mg \[0.3mL\] in patients with creatinine clearance between 30 and 50 mL/min) for at least 21 Days, up to complete mobilization, corresponding to cast or brace removal. The maximal duration of treatment is 45 days.
After randomization (Day 1), subjects will receive subcutaneously once daily nadroparin 2850 anti-Xa IU (0.3 mL) for at least 21 Days, up to complete mobilization, corresponding to cast or brace removal. The maximal duration of treatment is 45 days.