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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
625
Rivaroxaban 15 mg every 12 hours until the completion of the diagnostic work-up, which should not exceed 24 hours (maximum 2 tablets)
Ostfold Hospital Trust
Fredrikstad, Østfold fylke, Norway
Rate of serious bleedings and/or death related to bleeding
Serious bleedings and/or death related to bleeding encountered within 48 hours after the last rivaroxaban tablet was ingested in patients in whom DVT was excluded or until the ingestion of first tablet of oral anticoagulation or application of IV/SC heparin in those in whom DVT is confirmed.
Time frame: Until 48 hours after last tablet
Feasability rate
Assessed by the proportion of patients who can be managed by a scheduled work-up
Time frame: 12 hours
Failure rate
Worsening in pre-existing complaints or developement of signs/symptoms of pulmonary embolism
Time frame: until 48 hours after last tablet
90-day outcome
The 90-day outcome of the applied diagnostic strategy using Wells pre-test clinical probability, D-dimer and compression ultrasounography and safety of coagulation
Time frame: 90 days
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