This study involves patients who have a low number of platelets in their blood, a condition known as thrombocytopenia, and who need to have heart surgery. Platelets are small blood cells that help the blood to clot and stop bleeding. When the platelet count is low, there is a greater risk of bleeding during and after surgery. The treatment being tested in this study is romiplostim, which is a medication that helps the body produce more platelets. Some patients will receive romiplostim before their surgery, while others will receive a placebo. The medication will be given as an injection under the skin.
The purpose of this study is to find out if romiplostim given before heart surgery can help reduce the severity of low platelet counts after the surgery compared to placebo. Patients will receive their first injection between 14 and 10 days before their scheduled heart surgery. The study will look at the lowest platelet count that occurs from the end of the heart surgery until seven days after the surgery. The study will also track other factors such as how much bleeding occurs after surgery, whether patients need transfusions of platelets or other blood products, and how patients recover after their operation.
Throughout the study, doctors will monitor platelet counts and other blood measurements at different time points before and after surgery. They will also track any complications that may occur, such as bleeding events, blood clots in veins or arteries, infections, and how long patients need to stay in the intensive care unit and in the hospital. The study will follow patients for up to three months after surgery to assess their overall recovery and any side effects from the treatment. The treatment period with the study medication lasts for 14 days, and patients will receive up to three injections during this time.



France