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RECRUITING
NCT07278661
PHASE2

Preoperative Use of Romiplostim in Thrombocytopenic Patients Undergoing Cardiac Surgery.

Sponsor: Nantes University Hospital

View on ClinicalTrials.gov

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

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

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