Preoperative Use of Romiplostim in Thrombocytopenic Patients Undergoing Cardiac Surgery.
Preoperative Use of Romiplostim in Thrombocytopenic Patients Undergoing Cardiac Surgery. A Phase 3, Multicenter Randomized Double-blinded Controlled Against Placebo Study.
Nantes University Hospital
136 participants
Jul 16, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
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Interventions
The dosage for this first injection will be: * 2 µg/kg for patients with a platelet count at inclusion between 149,000 and 100,000/mm3 * 3 µg/kg for patients with a platelet count strictly below 100,000/mm3
NaCl (Sodium chloride) 0.9% administered subcutaneously
Locations(8)
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NCT07278661