Heart surgery hope: drug may raise low platelets before operation
NCT ID NCT07278661
First seen Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 1 time
Summary
This study tests a drug called romiplostim to see if it can safely increase platelet counts in people with low platelets before they have heart surgery. Low platelets can make surgery risky, and this treatment aims to reduce the need for blood transfusions. About 136 adults scheduled for heart surgery will receive either romiplostim or a placebo before their operation, and doctors will monitor their platelet levels and any side effects closely.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 136 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Adult patients with no upper age limit, * Scheduled cardiac surgery with cardiopulmonary bypass, * Patients with preoperative thrombocytopenia strictly \<150,000/mm3 * Surgery performed with a blood recovery system using centrifugation (Cell Saver type) or equivalent, * Feasibility of a first injection (Romiplostim or Placebo) between D-14 and D-10 before surgery, * Surgery requiring the administration of antiplatelet and/or anticoagulant therapy for a minimum of 1 month postoperatively. Exclusion Criteria: * Inability to administer the first injection of Romiplostim or Placebo within 10 days prior to surgery, * Cardiac surgery without cardiopulmonary bypass, * Coronary artery bypass graft surgery due to one or more significant coronary stenoses presenting with unstable angina (defined by anginal pain at rest, or with minimal exertion, or pain that has recently worsened), * 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, * Planned use of aprotinin as an antifibrinolytic agent during surgery, * Patients treated with clopidogrel (Plavix) or ticagrelor who cannot switch to acetylsalicylic acid (Kardégic) monotherapy at least 5 days before surgery. The study allows for continued use of acetylsalicylic acid (Kardégic) as well as anticoagulants, * Hereditary or acquired thrombophilia with or without a history of thrombosis, * History of ischemic or hemorrhagic stroke, * History of phlebitis, pulmonary embolism, or portal vein thrombosis, * History of myocardial infarction with coronary stenting that occurred less than one year ago, * Current limb immobilization (e.g., plaster cast for ankle fracture) or inability to walk independently due to limited mobility (e.g., paralysis), * Current immobilization of a limb (e.g., plaster cast for ankle fracture) or inability to walk independently due to motor limitation (e.g., complete paralysis of a limb) or medical contraindication (e.g., strict bed rest required), * Myelogram indicating malignant hematological disease or blast cells strictly greater than 5%, * Malignant diseases with last follow-up indicating disease progression, * Severe chronic liver disease with a CHILD-PUGH score \> 6 or B (measured without decompensation), * Treatment with thrombopoietin receptor agonist received within 3 months prior to inclusion, * Treatment with JAK2 inhibitor currently underway or within the last month, * Treatment with Rituximab within the last 7.5 months or intravenous immunoglobulin within the last 40 days, * Ongoing 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, * Known hemophilia, * Hypersensitivity to romiplostim or any of its excipients, or to proteins derived from E. coli, * Context of hyperchloremia, hypernatremia, or major water and salt retention with anasarca refractory to medical treatment, * Pregnant women or women of childbearing age who are not using effective contraception, * Currently using combined oral contraceptive pills or oral hormone replacement therapy containing estrogen, * Breastfeeding women, * Minors, * Adults under guardianship, curatorship, or judicial protection, * Patients who do not speak French, * Patients without Social Security coverage.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
8 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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CHU d'Angers
NOT_YET_RECRUITINGAngers, France
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CHU de Bordeaux
NOT_YET_RECRUITINGBordeaux, France
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CHU de Brest
NOT_YET_RECRUITINGBrest, France
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CHU de Dijon
NOT_YET_RECRUITINGDijon, France
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CHU de Nantes
RECRUITINGNantes, France
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CHU de Rennes
NOT_YET_RECRUITINGRennes, France
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CHU de Strasbourg
NOT_YET_RECRUITINGStrasbourg, France
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Hôpital Bichat (AP-HP)
NOT_YET_RECRUITINGParis, France
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