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Preoperative Use of Romiplostim in Thrombocytopenic Patients Undergoing Cardiac Surgery.
Sponsor: Nantes University Hospital
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.
Official title: Preoperative Use of Romiplostim in Thrombocytopenic Patients Undergoing Cardiac Surgery. A Phase 3, Multicenter Randomized Double-blinded Controlled Against Placebo Study.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
136
Start Date
2026-09-01
Completion Date
2028-12-01
Last Updated
2026-04-06
Healthy Volunteers
No
Interventions
Nplate
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 %0.9
NaCl (Sodium chloride) 0.9% administered subcutaneously
Locations (8)
CHU d'Angers
Angers, France
CHU de Bordeaux
Bordeaux, France
CHU de Brest
Brest, France
CHU de Dijon
Dijon, France
CHU de Nantes
Nantes, France
Hôpital Bichat (AP-HP)
Paris, France
CHU de Rennes
Rennes, France
CHU de Strasbourg
Strasbourg, France