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Preoperative use of Romiplostim in thrombocytopenic patients undergoing cardiac surgery. A Phase 3, multicenter randomized double-blinded controlled against placebo study
EU CTIS ID: 2024-517710-15-00
What this study is testing
To determine the efficacy of a platelet growth factor (Romiplostim) administered preoperatively in thrombocytopenic patients on the severity of thrombocytopenia after cardiac surgery compared with placebo.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adult patients with no upper age limit
- Programmed cardiac surgery with ECC
- Patient with pre-operative thrombocytopenia strictly <150,000/mm3
- Surgery performed with a centrifugal blood recovery system (Cell Saver type) or equivalent
- Feasibility of a 1st injection (Romiplostim or Placebo) between D-14 and D-10 before surgery
- Surgery requiring a minimum of 1 month post-operative antiaggregant and/or anticoagulant treatment
You likely can't join if
- Inability to perform the first injection of Romiplostim or Placebo within 10 days prior to surgery
- Coronary artery bypass grafting in patients with acute coronary syndrome, with or without ST-segment elevation, occurring within the past month
- 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
- Severe chronic liver disease with CHILD-PUGH score > 6 or B (measured without decompensation)
- Intended use of aprotinin as an antifibrinolytic agent during surgery
- Patient treated with Plavix or ticagrelor who cannot switch to Kardégic monotherapy at least 5 days prior to surgery. The study permits continued use of Kardégic, as well as continued use of anticoagulants
See the full eligibility criteria
- Adult patients with no upper age limit
- Programmed cardiac surgery with ECC
- Patient with pre-operative thrombocytopenia strictly <150,000/mm3
- Surgery performed with a centrifugal blood recovery system (Cell Saver type) or equivalent
- Feasibility of a 1st injection (Romiplostim or Placebo) between D-14 and D-10 before surgery
- Surgery requiring a minimum of 1 month post-operative antiaggregant and/or anticoagulant treatment
- Inability to perform the first injection of Romiplostim or Placebo within 10 days prior to surgery
- Coronary artery bypass grafting in patients with acute coronary syndrome, with or without ST-segment elevation, occurring within the past month
- 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
- Severe chronic liver disease with CHILD-PUGH score > 6 or B (measured without decompensation)
- Intended use of aprotinin as an antifibrinolytic agent during surgery
- Patient treated with Plavix or ticagrelor who cannot switch to Kardégic monotherapy at least 5 days prior to surgery. The study permits continued use of Kardégic, as well as continued use of anticoagulants
- History of myocardial infarction with coronary stenting within the past year
- 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)
- Treatment with thrombopoietin receptor agonists received within 3 months prior to inclusion
- 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
- Hypersensitivity to Romiplostim or any of its excipients, or to proteins derived from E. coli.
- Cardiac surgery without extracorporeal circulation
- Context of hyperchloremia, hypernatremia, or major water and sodium retention with anasarca refractory to medical treatment
- Treatment with JAK2 inhibitor in progress or less than 1 month old
- Known hemophilia
- Pregnant woman or woman of childbearing age not using effective contraception
- Current contraception with estrogen-progestin pill or estrogen-containing oral hormone replacement therapy
- Nursing mother
- Minor
- Major under guardianship, curatorship or safeguard of justice
- Treatment with Rituximab within the last 7.5 months or intravenous immunoglobulin within the last 40 days
- Patients who do not speak French
- Patient without Social Security
- Known hereditary or acquired thrombophilia, with or without a history of thrombosis
- History of ischemic or hemorrhagic stroke
- History of phlebitis, pulmonary embolism or portal thrombosis
- Myelogram in favor of hematologic malignancy or blasts strictly greater than 5%
- Malignant pathologies with last follow-up in favor of disease progression
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.