drugset / Trial / NCT07278661

Preoperative Use of Romiplostim in Thrombocytopenic Patients Undergoing Cardiac Surgery.

NCT07278661

Phase 2 Recruiting 136 enrolled Nantes University Hospital
RandomizedParallel-groupDouble-blindTreatment

Summary

Romiplostim has demonstrated its efficacy and good tolerance in multiple indications. If the efficacy of Romiplostim is confirmed in this population, thrombocytopenic patients will be able to undergo cardiac surgery, which is generally life-saving, without prior thrombocytopenia. Patients included in the study will be hospitalized within 15 days of the first administration of the study treatment and will be closely monitored clinically and biologically for at least 10 days after surgery. The occurrence of an adverse event can therefore be quickly detected and managed. Collectively, "Patient Blood Management" strategies are mainly focused on the management of preoperative anemia. If positive, this study will enrich the therapeutic arsenal available for optimizing patients in preparation for major surgery. As no major collective complications are expected, the collective benefit/risk ratio also appears favorable.

Timeline

Start
2026-09-01
Primary completion
2028-12-01
Completion
2028-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Romiplostim Peptide 2 ug/kg Subcutaneous
Subject Romiplostim Peptide 3 ug/kg Subcutaneous

Indications