Preoperative Use of Romiplostim in Thrombocytopenic Patients Undergoing Cardiac Surgery.

NCT07278661 | Not Yet Recruiting Phase 2

• 2 other identifiers: RC24_04582024-517710-15-00
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 8

Brief 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. 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

Keywords

Thrombocytopenia; Cardiac Surgery; Growth Factor; Patient Blood Management

Outcome Measures

Primary Outcomes (1)

• Efficacy

  Lowest platelet count measured between the end of ECC and the 7th postoperative day with D0 = day of surgery

  Day 7

Secondary Outcomes (20)

• Transfusion of platelet concentrate

  Day 1

• Transfusion of platelet concentrate

  Day 7

• Transfusion of platelet concentrate

  Day 28

• Transfusion of red blood cell concentrate

  Day 1

• Transfusion of red blood cell concentrate

  Day 7

Study Arms (2)

Romiplostim

EXPERIMENTAL

injection sc

Drug: Nplate

NaCl

PLACEBO COMPARATOR

injection sc

Drug: NaCl %0.9

Interventions

Nplate DRUG

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

Romiplostim

NaCl %0.9 DRUG

NaCl (Sodium chloride) 0.9% administered subcutaneously

NaCl

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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,
• Surgery requiring the administration of antiplatelet and/or anticoagulant therapy for a minimum of 1 month postoperatively.

You may not qualify 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 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),

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (8)

CHU d'Angers

Angers, France

Location

CHU de Bordeaux

Bordeaux, France

Location

CHU de Brest

Brest, France

Location

CHU de Dijon

Dijon, France

Location

CHU de Nantes

Nantes, France

Location

Hôpital Bichat (AP-HP)

Paris, France

Location

CHU de Rennes

Rennes, France

Location

CHU de Strasbourg

Strasbourg, France

Location

MeSH Terms

Conditions

Thrombocytopenia

Interventions

romiplostim; Sodium Chloride

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Jean- Christophe RIGAL

CONTACT

+33 240165304; jeanchristophe.rigal@chu-nantes.fr

Astrid GARREAU

CONTACT

astrid.garreau@chu-nantes.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 12, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

FR (8)