A Phase 3 interventional study of Fondaparinux and Enoxaparin in Venous Thromboembolism, sponsored by Eastern Virginia Medical School. Terminated. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2022-04-11.
Sponsored by Eastern Virginia Medical School · Phase 3, Interventional, and Prevention
This is a pilot study to evaluate safety of fondaparinux and enoxaparin in terms of bleeding and development of thrombocytopenia in the medical ICU population.
This is a pilot study to evaluate safety of fondaparinux and enoxaparin in terms of bleeding and development of thrombocytopenia in the medical ICU population. We expect the null hypothesis to be proven true. One hundred subjects will be enrolled in this prospective, randomized, double-blind (concealed allocation) pilot study of consecutive medical ICU patients to one of two pharmacologic VTE prophylaxix treatment arms. (1) Primary endpoints include hemoglobin, hematocrit, \& platelet counts. blood product utilization, bleeding complications (any), Steady State Functional Factor Xa activity (for post hoc analysis), non-study pharmacologic VTE prophylaxis (when estimated CLcr \< 30ml/min), and days not treated with study drug or treated with alternative agent Secondary/ Additional Data to be collected include patient demographics, primary \& secondary diagnoses, central venous access, and sequential compression device utilization.
818 studies on the registry are indexed under Thromboembolism; 98 are open to participants now.
This study's enrollment of 27 is below the median of 196 across 436 interventional studies indexed under Thromboembolism.
Browse Thromboembolism studies →Eastern Virginia Medical School is the lead sponsor of 56 studies on the registry; 8 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Fondaparinux treatment - one standard of care option
Drug: Fondaparinux
Enoxaparin
Drug: Enoxaparin
The dose for Arixtra is 2.5 mg once daily, subcutaneously.
Also known as: Arixtra
The dose for Lovenox is 40 mg once daily, subcutaneously.
Also known as: Lovenox
Bleeding events
Time frame: inpatient hospitalization
Development of thrombocytopenia
Time frame: inpatient hospitalization
No study locations are listed for this record.
This study is terminated, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Eastern Virginia Medical School