Deep Venous Thrombosis Clinical Trial
Official title:
Rivaroxaban for Scheduled Work-up of Patients With Suspected Deep Venous Thrombosis
This prospective outcome study is designed to assess the safety of rivaroxaban in the pre-diagnosis phase of DVT.
This prospective outcome study is designed to assess the safety of rivaroxaban in the
pre-diagnosis phase of DVT.
International guidelines suggest the use of low molecular weight heparin (LMWH) if the
diagnostic process is expected to be delayed for more than 4 hours.
Rivaroxaban is a new DOAC that in clinical trials has proven to be non-inferior to LMWH and
warfarin for the treatment of DVT with the added benefit of causing less major bleeding.
Because of its rapid onset of action and oral administration, rivaroxaban could be used
instead of LMWH in the pre-diagnosis phase pending the results of the diagnostic test.
However, the safety of a such proposed indication has to be proven before it can be adopted
in clinical practice.
This study aims to determine the safety and feasibility of pre-diagnostic treatment with
rivaroxaban. The primary outcome of this study "safety" is a composite endpoint of serious
bleedings encountered within 48 hours after administration of rivaroxaban.
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