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New treatment option for Chirurgical Intervention
Official title Preoperative Use of Romiplostim in Thrombocytopenic Patients Undergoing Cardiac Surgery.
ClinicalTrials.gov ID: NCT07278661
What this study is testing
What is Nplate?
Nplate is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for chirurgical intervention.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Romiplostim has demonstrated its efficacy and good tolerance in multiple indications. If the efficacy of Romiplostim is confirmed in this population, thrombocytopenic patients will be able to undergo cardiac surgery, which is generally life-saving, without prior thrombocytopenia.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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,
You likely can't join if
- Inability to administer the first injection of Romiplostim or Placebo within 10 days prior to surgery,
- Cardiac surgery without cardiopulmonary bypass,
- Coronary artery bypass grafting due to one or more significant coronary stenoses,
- Tangential filtration blood recovery system (i-SEP SAME® type) planned for intraoperative use or absence of intraoperative blood recovery system due...
- Planned use of aprotinin as an antifibrinolytic agent during surgery,
- Patient with contraindication to discontinuation of all antiplatelet therapy before surgery (with discontinuation at least 3 days before surgery for...
See the full eligibility 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.
- Inability to administer the first injection of Romiplostim or Placebo within 10 days prior to surgery,
- Cardiac surgery without cardiopulmonary bypass,
- Coronary artery bypass grafting due to one or more significant coronary stenoses,
- 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,
- Patient with contraindication to discontinuation of all antiplatelet therapy before surgery (with discontinuation at least 3 days before surgery for acetylsalicylic acid and at least 5 days before surgery for...
- 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 heart attack with stent placement 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...
- 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 (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.
The study team makes the final eligibility decision.
Where it's taking place
- Angers, France
- Bordeaux, France
- Brest, France
- Dijon, France
- Nantes, France
- Paris, France
- Rennes, France
- Strasbourg, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Angers, France; Bordeaux, France; Brest, France; Dijon, France; Nantes, France; Paris, France and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.