Randomized double blind placebo-control trial that faced slow recruitment thus faces the problem of being underpowered to detect a difference.
Outpatients without cancer or prior VTE with symptomatic calf DVT. Assigned 1:1 to receive nadroparin or placebo daily for 6 weeks. All were given compression stockings and followed for 90 days.
Primary outcome was extension to proximal vein, contralateral proximal DVT, or systemic embolism by day 42.
Safety outcome – non-major bleeding by day 42.
122 patients in nadroparin and 130 placebo.
Primary outcome 3% in the nadroparin and 5% in placebo. 5 patients had bleeding in nadroparin arm with 1 major bleeding event.
Need more information before change in practice.
Anticoagulant therapy for symptomatic calf deep vein thrombosis (CACTUS): a randomised, double-blind, placebo-controlled trial – M Righini et al; Lancet Haematology, The, 2016-12-01, Volume 3, Issue 12, Pages e556-e562.