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Heart surgery hope: drug may raise low platelets before operation

NCT ID NCT07278661

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 136 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    8 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • CHU d'Angers

    NOT_YET_RECRUITING

    Angers, France

  • CHU de Bordeaux

    NOT_YET_RECRUITING

    Bordeaux, France

  • CHU de Brest

    NOT_YET_RECRUITING

    Brest, France

  • CHU de Dijon

    NOT_YET_RECRUITING

    Dijon, France

  • CHU de Nantes

    RECRUITING

    Nantes, France

  • CHU de Rennes

    NOT_YET_RECRUITING

    Rennes, France

  • CHU de Strasbourg

    NOT_YET_RECRUITING

    Strasbourg, France

  • Hôpital Bichat (AP-HP)

    NOT_YET_RECRUITING

    Paris, France

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