PROTECT (nadroparin), trial summary

Ongoing trial

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A randomised clinical trial investigating the effect of nadroparin versus no treatment in patients with a nonsurgical fracture of the lower extremity requiring immobilisation in a below-knee plaster cast

        Z

NCT00881088    



Studied treatment nadroparin 0,3 cc daily during immobilization
Control treatment no treatment

3rd arm with fundaparinux



Patients patients with a nonsurgical fracture of the lower extremity requiring immobilisation in a below-knee plaster cast
Group sizes-9 / -9
Type of immobilization.
Type of injury requiring immobilization.
Screening method



Blindness single blind Inclusion period
Follow-up duration 6 weeks Centers
Lost to FU geographical localisation
Primary endpoint deep vein trombosis as detected by venous duplex 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

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ClinicalTrial.gov record NCT00881088



Registering number NCT00881088 (see trial on clinicaltrials.gov)
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All trials of nadroparin

Appears in following systematic reviews: