Romiplostim for Thrombocytopenia

Inclusion criteria

• {"criterion_text":"- Adult patients with no upper age limit"}
• {"criterion_text":"- Programmed cardiac surgery with ECC"}
• {"criterion_text":"- Patient with pre-operative thrombocytopenia strictly <150,000/mm3"}
• {"criterion_text":"- Surgery performed with a centrifugal blood recovery system (Cell Saver type) or equivalent"}
• {"criterion_text":"- Feasibility of a 1st injection (Romiplostim or Placebo) between D-14 and D-10 before surgery"}
• {"criterion_text":"- Surgery requiring a minimum of 1 month post-operative antiaggregant and/or anticoagulant treatment"}

Exclusion criteria

• {"criterion_text":"- Inability to perform the first injection of Romiplostim or Placebo within 10 days prior to surgery"}
• {"criterion_text":"- Coronary artery bypass graft surgery due to one or more significant coronary stenoses"}
• {"criterion_text":"- Tangential filtration blood recovery system (i-SEP SAME® type) planned for intraoperative use or absence of intraoperative blood recovery system due to investigator choice or availability issues"}
• {"criterion_text":"- Severe chronic liver disease with CHILD-PUGH score > 6 (measured without decompensation)"}
• {"criterion_text":"- Intended use of aprotinin as an antifibrinolytic agent during surgery"}
• {"criterion_text":"- Patient with contraindication to discontinuing all antiplatelet therapy prior to surgery (with discontinuation of at least 3 days for acetylsalicylic acid and at least 5 days for clopidogrel/ticagrelor)"}
• {"criterion_text":"- History of heart attack with stent placement less than one year ago"}
• {"criterion_text":"- Immobilization of a limb (e.g., plaster cast for a broken ankle) or inability to walk independently due to motor impairment (e.g., complete paralysis of a limb) or medical contraindication (e.g., strict bed rest required)"}
• {"criterion_text":"- Treatment with thrombopoietin receptor agonists received within 3 months prior to inclusion"}
• {"criterion_text":"- Current treatment with corticosteroids at doses equal to or greater than 20mg of hydrocortisone, 5mg of prednisone/or prednisolone, 4mg of methylprednisone, or 0.75mg of dexamethasone"}
• {"criterion_text":"- Hypersensitivity to Romiplostim or any of its excipients, or to proteins derived from E. coli."}
• {"criterion_text":"- Cardiac surgery without extracorporeal circulation"}
• {"criterion_text":"- Context of hyperchloremia, hypernatremia, or major water and sodium retention with anasarca refractory to medical treatment"}
• {"criterion_text":"- Treatment with JAK2 inhibitor in progress or less than 1 month old"}
• {"criterion_text":"- Known hemophilia"}
• {"criterion_text":"- Pregnant woman or woman of childbearing age not using effective contraception"}
• {"criterion_text":"- Current contraception with estrogen-progestin pill or estrogen-containing oral hormone replacement therapy"}
• {"criterion_text":"- Nursing mother"}
• {"criterion_text":"- Minor"}
• {"criterion_text":"- Major under guardianship, curatorship or safeguard of justice"}
• {"criterion_text":"- Treatment with Rituximab within the last 7.5 months or intravenous immunoglobulin within the last 40 days"}
• {"criterion_text":"- Patients who do not speak French"}
• {"criterion_text":"- Patient without Social Security"}
• {"criterion_text":"- Known hereditary or acquired thrombophilia, with or without a history of thrombosis"}
• {"criterion_text":"- History of ischemic or hemorrhagic stroke"}
• {"criterion_text":"- History of phlebitis, pulmonary embolism or portal thrombosis"}
• {"criterion_text":"- Myelogram in favor of hematologic malignancy or blasts strictly greater than 5%"}
• {"criterion_text":"- Malignant pathologies with last follow-up in favor of disease progression"}

Primary endpoints

• {"endpoint_text":"- Lowest platelet count measured between the end of CEC and the 7th postoperative day with D0 = day of surgery. This criterion will take into account any tests performed at the hospital or in the city (if the patient is discharged from the hospital before the 7th postoperative day).","definition_or_measurement_approach":"Lowest platelet count measured between the end of cardiopulmonary bypass (CEC) and postoperative day 7; includes any laboratory tests performed at the hospital or in the community if patient discharged prior to day 7."}

Secondary endpoints

• {"endpoint_text":"- Transfusion of platelet concentrate (PC) (yes/no and number) - Per-operatively up to 24th hour, per-operatively up to 7th day, per-operatively up to 28th day","definition_or_measurement_approach":"Recording of platelet concentrate transfusion (yes/no and number) at peri-operative intervals: up to 24 hours, up to 7 days, and up to 28 days post-operation."}
• {"endpoint_text":"- Transfusion of red blood cell concentrate (RGC) (yes/no and number) - Per-operatively up to 24th hour, per-operatively up to 7th day, per-operatively up to 28th day","definition_or_measurement_approach":"Recording of red blood cell concentrate transfusion (yes/no and number) at peri-operative intervals: up to 24 hours, up to 7 days, and up to 28 days post-operation."}
• {"endpoint_text":"- Transfusion of fresh frozen plasma (FFP) (yes/no and number) - Per-operatively up to 24th hour, per-operatively up to 7th day, per-operatively up to 28th day","definition_or_measurement_approach":"Recording of fresh frozen plasma transfusion (yes/no and number) at peri-operative intervals: up to 24 hours, up to 7 days, and up to 28 days post-operation."}
• {"endpoint_text":"- Administration of blood-derived drugs: fibrinogen, prothrombin complex concentrates, recombinant activated factor VII - Per-operatively up to 24th hour, per-operatively up to 7th day, per-operatively up to 28th day","definition_or_measurement_approach":"Recording administration (yes/no and amount) of blood-derived haemostatic agents at peri-operative intervals: up to 24 hours, up to 7 days, and up to 28 days post-operation."}
• {"endpoint_text":"- Lowest platelet count in the first 28 days post-operatively","definition_or_measurement_approach":"Lowest measured platelet count within 28 days after surgery."}
• {"endpoint_text":"- Highest platelet count in the first 7 days and in the first 28 days post-operatively","definition_or_measurement_approach":"Highest measured platelet count within first 7 days and within first 28 days post-operation."}
• {"endpoint_text":"- Lowest haemoglobin in the first 7 days and in the first 28 days post-operatively","definition_or_measurement_approach":"Lowest measured hemoglobin within first 7 days and within first 28 days post-operation."}
• {"endpoint_text":"- Post-operative bleeding volume: - From sternal closure to 12th post-operative hour, - From discharge to 24th post-operative hour - From the 24th postoperative hour to drain removal, - Classification of bleeding according to UDPB classes,65 - Surgical revision (including sternal reopening), - Intraoperative blood recovery (volume treated and volume restored).","definition_or_measurement_approach":"Measurement of postoperative bleeding volumes in defined intervals (sternal closure to 12 hours; discharge to 24 hours; 24 hours to drain removal), classification by UDPB classes, recording of surgical revision events (including sternal reopening), and intraoperative blood recovery volumes (treated and restored)."}
• {"endpoint_text":"- Postoperative morbidity and mortality: - Intraoperative and 24h bleeding/hemorrhagic events - Duration of mechanical ventilation in intensive care unit (in hours), - Bleeding event within 3 months post-op: - Venous and arterial thromboembolic events within 3 months post-operatively - Infection within 3 months : - Organ dysfunction, - Length of stay in intensive care unit, - Length of hospital stay, - Mortality at D28 post-op.","definition_or_measurement_approach":"Composite recording of postoperative morbidity and mortality including intraoperative/24h bleeding events, duration of mechanical ventilation (hours), bleeding events within 3 months, venous/arterial thromboembolic events within 3 months, infections within 3 months, organ dysfunction, ICU length of stay, hospital length of stay, and mortality at day 28 post-operation."}

France

Earliest CTIS Part Ii Submission Date

25-07-2025

Latest Decision Or Authorization Date

15-12-2025

Processing Time Days

143

Number Of Sites

8

Number Of Participants

136

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Nantes

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France