PROTECT (fundaparinux), trial summary

Ongoing trial

   PDF trial summary

A randomised clinical trial investigating the effect of fondaparinux versus no treatment in Patients with a nonsurgical fracture of the lower extremity immobilised in a below-knee plaster cast

        Z

NCT00881088    



Studied treatment fondaparinux 2,5 mg daily group during immobilization
Control treatment no treatment

3rd arm with nadroparin



Patients Patients with a nonsurgical fracture of the lower extremity immobilised in a below-knee plaster cast
Group sizes-9 / -9
Inclusion criteriaat least 18 years; with a nonsurgical fracture of the lower extremity requiring immobilisation in a below-knee plaster cast for a minimum of 4 weeks;
Type of immobilization.
Type of injury requiring immobilization.
Screening method



Blindness single blind Inclusion period
Follow-up duration Centers
Lost to FU geographical localisation
Primary endpoint deep vein trombosis as detected by venous duplex Design Parallel groups

estimated enrollment n=669



EndpointX1N1X0N0TE95% CI asymptomatic proximal DVT, symptomatic VTE, all death - -9 - -9 no data PE - -9 - -9 no data distal DVT - -9 - -9 no data proximal deep vein thrombosis - -9 - -9 no data DVT - -9 - -9 no data VTE (symptomatic or asymptomatic) - -9 - -9 no data symptomatic VTE - -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 NCT00881088



Registering number NCT00881088 (see trial on clinicaltrials.gov)
Code Name