FONDACAST, trial summary

Ongoing trial

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A randomised clinical trial investigating the effect of fondaparinux versus 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

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NCT00843492    



Studied treatment subcutaneously, once daily, fondaparinux 2.5 mg for at least 21 Days, up to complete mobilization, with a maximal duration of treatment of 45 days
(1.5 mg in patients with creatinine clearance between 30 and 50 mL/min)
Control treatment daily nadroparin 2850 anti-Xa IU (0.3 mL) for at least 21 Days, up to complete mobilization



Patients 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
Group sizes-9 / -9
Type of immobilization.
Type of injury requiring immobilization.
Screening method



Blindness open Inclusion period
Follow-up duration 5 weeks Centers
Lost to FU geographical localisation Europe
Primary endpoint Design Parallel groups



EndpointX1N1X0N0TE95% CI distal DVT - -9 - -9 no data proximal deep vein thrombosis - -9 - -9 no data DVT - -9 - -9 no data asymptomatic proximal DVT, symptomatic VTE, all death - -9 - -9 no data PE - -9 - -9 no data symptomatic VTE - -9 - -9 no data VTE (symptomatic or asymptomatic) - -9 - -9 no data major or clinically relevant bleeding - -9 - -9 no data minor bleeding - -9 - -9 no data0,22,01,0

ClinicalTrial.gov record NCT00843492



Registering number NCT00843492 (see trial on clinicaltrials.gov)
Code Name

 

All trials of fondaparinux

Appears in following systematic reviews: