NCT07278661

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.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 136 (estimated)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chirurgical Intervention
• Thrombocytopaenia

Interventions

Type	Name	Description
DRUG	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
DRUG	NaCl %0.9	NaCl (Sodium chloride) 0.9% administered subcutaneously

Timeline

• Start date: 2026-09-01
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2025-12-12
• Last updated: 2026-04-06

Locations

8 sites across 1 country: France