Preoperative Use of Romiplostim in Thrombocytopenic Patients Undergoing Cardiac Surgery. (CT-PLATE)

March 31, 2026 updated by: Nantes University Hospital

Preoperative Use of Romiplostim in Thrombocytopenic Patients Undergoing Cardiac Surgery. A Phase 3, Multicenter Randomized Double-blinded Controlled Against Placebo Study.

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.

Patients included in the study will be hospitalized within 15 days of the first administration of the study treatment and will be closely monitored clinically and biologically for at least 10 days after surgery. The occurrence of an adverse event can therefore be quickly detected and managed.

Collectively, "Patient Blood Management" strategies are mainly focused on the management of preoperative anemia. If positive, this study will enrich the therapeutic arsenal available for optimizing patients in preparation for major surgery. As no major collective complications are expected, the collective benefit/risk ratio also appears favorable.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

136

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 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 clopidogrel/ticagrelor),
  • 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 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 (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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Romiplostim
injection sc
Drug: Nplate

The dosage for this first injection will be:

  • 2 µg/kg for patients with a platelet count at inclusion between 149,000 and 100,000/mm3
  • 3 µg/kg for patients with a platelet count strictly below 100,000/mm3
Placebo Comparator: NaCl
injection sc
Drug: NaCl %0.9
NaCl (Sodium chloride) 0.9% administered subcutaneously

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy
Time Frame: Day 7
Lowest platelet count measured between the end of ECC and the 7th postoperative day with D0 = day of surgery
Day 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transfusion of platelet concentrate
Time Frame: Day 1
Number of transfusion of platelet concentrate
Day 1
Transfusion of platelet concentrate
Time Frame: Day 7
Number of transfusion of platelet concentrate
Day 7
Transfusion of platelet concentrate
Time Frame: Day 28
Number of transfusion of platelet concentrate
Day 28
Transfusion of red blood cell concentrate
Time Frame: Day 1
Number of transfusion of red blood cell concentrate
Day 1
Transfusion of red blood cell concentrate
Time Frame: Day 7
Number of transfusion of red blood cell concentrate
Day 7
Transfusion of red blood cell concentrate
Time Frame: Day 28
Number of transfusion of red blood cell concentrate
Day 28
Transfusion of fresh frozen plasma
Time Frame: Day 1
Number of transfusion of fresh frozen plasma
Day 1
Transfusion of fresh frozen plasma
Time Frame: Day 7
Number of transfusion of fresh frozen plasma
Day 7
Administration of blood-derived drugs
Time Frame: Day 1
Number of administration of blood-derived drugs
Day 1
Administration of blood-derived drugs
Time Frame: Day 7
Number of administration of blood-derived drugs
Day 7
Administration of blood-derived drugs
Time Frame: Day 28
Number of administration of blood-derived drugs
Day 28
Efficacy
Time Frame: Day 28
Lowest platelet count measured between the end of ECC and the 28th postoperative day with D0 = day of surgery
Day 28
Efficacy
Time Frame: Day 7
Highest platelet count measured between the end of ECC and the 7th postoperative day with D0 = day of surgery
Day 7
Efficacy
Time Frame: Day 28
Highest platelet count measured between the end of ECC and the 28th postoperative day with D0 = day of surgery
Day 28
Lowest haemoglobin
Time Frame: Day 7
Lowest haemoglobincount measured between the end of ECC and the 7th postoperative day with D0 = day of surgery
Day 7
Lowest haemoglobin
Time Frame: Day 28
Lowest haemoglobincount measured between the end of ECC and the 28th postoperative day with D0 = day of surgery
Day 28
Bleeding volume
Time Frame: Hour 12
Post-operative bleeding volume from sternal closure to 12th post-operative hour
Hour 12
Bleeding volume
Time Frame: Day 1
Post-operative bleeding volume from sternal closure to 24th post-operative hour
Day 1
Mortality
Time Frame: Day 28
Rate of mortality
Day 28
Infection
Time Frame: Month 3
Rate of infection
Month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

December 1, 2025

First Submitted That Met QC Criteria

December 1, 2025

First Posted (Actual)

December 12, 2025

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC24_0458
  • 2024-517710-15-00 (Ctis)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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