RecruitingPhase 2NCT07278661

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.


Sponsor

Nantes University Hospital

Enrollment

136 participants

Start Date

Jul 16, 2026

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called NaCl %0.9 and a drug called Nplate for people with chirurgical intervention and thrombocytopaenia. The study is currently recruiting participants at 8 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNplate

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

DRUGNaCl %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

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NCT07278661


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