Chirurgical InterventionPhase 2CT-PLATENCT07278661
Preoperative Use of Romiplostim in Thrombocytopenic Patients Undergoing Cardiac Surgery.
A Phase 2 study testing Nplate and NaCl %0.9 in people with Chirurgical Intervention and Thrombocytopaenia, run by Nantes University Hospital at 8 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chirurgical Intervention, Thrombocytopaenia
- What is being tested?
- Nplate and NaCl %0.9
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 142 participants
- Where
- 8 sitesFrance
- Study dates
- 16 Jul 2026to 1 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
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- 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 while on dual antiplatelet therapy, without the option of switching to acetylsalicylic acid monotherapy prior to surgery (the study permits continued concomitant curative anticoagulation),
- 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.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Astrid GARREAU contact
8 sites in 1 country
France8 sites, 8 recruiting
- Not yet recruiting
CHU d'Angers
Angers
Emmanuel RINEAU, emmauel.rineau@chu-angers.fr
- Not yet recruiting
CHU de Bordeaux
Bordeaux
Alexandre OUATTARA, alexandre.ouattara@chu-bordeaux.fr
- Not yet recruiting
CHU de Brest
Brest
Jean-Férreol OILLEAU, jean-ferreol.oilleau@chu-brest.fr
- Not yet recruiting
CHU de Dijon
Dijon
Pierre-Grégoire GUINOT, pierregregoire.guinot@chu-dijon.fr
- Recruiting
CHU de Nantes
Nantes
Jean-Christophe RIGAL, jeanchristophe.rigal@chu-nantes.fr
- Not yet recruiting
Hôpital Bichat (AP-HP)
Paris
Sophie PROVENCHERE, sophie.provenchere@aphp.fr
- Not yet recruiting
CHU de Rennes
Rennes
Nicolas NESSELER, nicolas.nesseler@chu-rennes.fr
- Not yet recruiting
CHU de Strasbourg
Strasbourg
Walid OULERHI, walid.oulerhi@chru-strasbourg.fr
About this study
Official title: 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.
- Conditions
- Chirurgical Intervention, Thrombocytopaenia
- Being tested
- Nplate, NaCl %0.9
- Keywords
- Thrombocytopenia, Cardiac Surgery, Growth Factor, Patient Blood Management
- Medical subject headings
- Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NplateDrug
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
NaCl %0.9Drug
NaCl (Sodium chloride) 0.9% administered subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| Romiplostim | Experimental | injection sc Receives: Drug: Nplate |
| NaCl | Placebo comparator | injection sc Receives: Drug: NaCl %0.9 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
Lowest platelet count measured between the end of ECC and the 7th postoperative day with D0 = day of surgery
Measured: Day 7
Secondary outcomes (20)
Transfusion of platelet concentrate
Number of transfusion of platelet concentrate
Measured: Day 1
Transfusion of platelet concentrate
Number of transfusion of platelet concentrate
Measured: Day 7
Transfusion of platelet concentrate
Number of transfusion of platelet concentrate
Measured: Day 28
Transfusion of red blood cell concentrate
Number of transfusion of red blood cell concentrate
Measured: Day 1
Transfusion of red blood cell concentrate
Number of transfusion of red blood cell concentrate
Measured: Day 7
Transfusion of red blood cell concentrate
Number of transfusion of red blood cell concentrate
Measured: Day 28
Transfusion of fresh frozen plasma
Number of transfusion of fresh frozen plasma
Measured: Day 1
Transfusion of fresh frozen plasma
Number of transfusion of fresh frozen plasma
Measured: Day 7
Administration of blood-derived drugs
Number of administration of blood-derived drugs
Measured: Day 1
Administration of blood-derived drugs
Number of administration of blood-derived drugs
Measured: Day 7
Administration of blood-derived drugs
Number of administration of blood-derived drugs
Measured: Day 28
Efficacy
Lowest platelet count measured between the end of ECC and the 28th postoperative day with D0 = day of surgery
Measured: Day 28
Efficacy
Highest platelet count measured between the end of ECC and the 7th postoperative day with D0 = day of surgery
Measured: Day 7
Efficacy
Highest platelet count measured between the end of ECC and the 28th postoperative day with D0 = day of surgery
Measured: Day 28
Lowest haemoglobin
Lowest haemoglobincount measured between the end of ECC and the 7th postoperative day with D0 = day of surgery
Measured: Day 7
Lowest haemoglobin
Lowest haemoglobincount measured between the end of ECC and the 28th postoperative day with D0 = day of surgery
Measured: Day 28
Bleeding volume
Post-operative bleeding volume from sternal closure to 12th post-operative hour
Measured: Hour 12
Bleeding volume
Post-operative bleeding volume from sternal closure to 24th post-operative hour
Measured: Day 1
Mortality
Rate of mortality
Measured: Day 28
Infection
Rate of infection
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start16 Jul 2026
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chirurgical InterventionStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07278661
- Sponsor's protocol ID
- RC24_0458
- Other IDs
- 2024-517710-15-00
- Acronym
- CT-PLATE
- Status last verified
- Oct 2026
- First submitted
- 1 Dec 2025
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Use of Romiplostim in Thrombocytopenic Patients Undergoing Cardiac Surgery. A Phase 3, Multicenter Randomized Double-blinded Controlled Against Placebo Study.
- ClinicalTrials.gov ID
- NCT07278661
- Acronym / sponsor ID
- CT-PLATE / RC24_0458
- Conditions
- Chirurgical Intervention, Thrombocytopaenia
- Keywords
- Thrombocytopenia, Cardiac Surgery, Growth Factor, Patient Blood Management
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 16 Jul 2026 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 12 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Romiplostim | Experimental | Drug: Nplateinjection sc |
| NaCl | Placebo comparator | Drug: NaCl %0.9injection sc |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (29 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NplateThe 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 | Drug | Romiplostim |
| NaCl %0.9NaCl (Sodium chloride) 0.9% administered subcutaneously | Drug | NaCl |
Primary outcome
Efficacy
Time frame: Day 7
Lowest platelet count measured between the end of ECC and the 7th postoperative day with D0 = day of surgery
20 secondary outcomes
Transfusion of platelet concentrate
Time frame: Day 1
Transfusion of platelet concentrate
Time frame: Day 7
Transfusion of platelet concentrate
Time frame: Day 28
Transfusion of red blood cell concentrate
Time frame: Day 1
Transfusion of red blood cell concentrate
Time frame: Day 7
Transfusion of red blood cell concentrate
Time frame: Day 28
Transfusion of fresh frozen plasma
Time frame: Day 1
Transfusion of fresh frozen plasma
Time frame: Day 7
Administration of blood-derived drugs
Time frame: Day 1
Administration of blood-derived drugs
Time frame: Day 7
Administration of blood-derived drugs
Time frame: Day 28
Efficacy
Time frame: Day 28
Efficacy
Time frame: Day 7
Efficacy
Time frame: Day 28
Lowest haemoglobin
Time frame: Day 7
Lowest haemoglobin
Time frame: Day 28
Bleeding volume
Time frame: Hour 12
Bleeding volume
Time frame: Day 1
Mortality
Time frame: Day 28
Infection
Time frame: Month 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Astrid GARREAU contact
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nplate and NaCl %0.9 in people with Chirurgical Intervention and Thrombocytopaenia, run by Nantes University Hospital at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean- Christophe RIGAL (+33 240165304, jeanchristophe.rigal@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy (time frame: Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.