Phase 2 Study of Romiplostim Before Cardiac Surgery to Help Patients with Low Platelet Counts

What this Trial Is About

This research evaluates the use of Romiplostim in adults with thrombocytopenia who are scheduled for cardiac surgery involving cardiopulmonary bypass. The study aims to confirm if Romiplostim can improve platelet counts before surgery, potentially allowing patients with low platelets to safely undergo this life-saving procedure. The study is a Phase 3, randomized, double-blind trial sponsored by Nantes University Hospital, focusing on treatment effectiveness and safety in this specific population. Participants will be randomly assigned to receive either Romiplostim or a placebo injection under the skin. The Romiplostim dosage is based on platelet count at inclusion, with 2 gkg for counts between 100,000 and 149,000mm3 and 3 gkg for counts below 100,000mm3. The injection is given between 10 and 14 days before surgery. Surgery will be performed with a blood recovery system, and patients will receive antiplatelet or anticoagulant therapy for at least one month after surgery as required. During the study, participants will be hospitalized within 15 days of the first injection and closely monitored for at least 10 days after surgery with clinical and biological assessments. Researchers will measure platelet recovery and transfusion needs at multiple time points up to 28 days after surgery, along with bleeding volume, hemoglobin levels, infection rates, and mortality. This comprehensive monitoring aims to detect any adverse events promptly and evaluate the treatments impact on surgical outcomes and blood management.

Preoperative Use of Romiplostim in Thrombocytopenic Patients Undergoing Cardiac Surgery.