Actively Recruiting
Preoperative Use of Romiplostim in Thrombocytopenic Patients Undergoing Cardiac Surgery.
Led by Nantes University Hospital · Updated on 2026-04-06
136
Participants Needed
8
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Preoperative Use of Romiplostim in Thrombocytopenic Patients Undergoing Cardiac Surgery.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients with no upper age limit
- Scheduled cardiac surgery with cardiopulmonary bypass
- Preoperative thrombocytopenia with platelet count strictly below 150,000/mm3
- Surgery performed with a blood recovery system using centrifugation (Cell Saver type) or equivalent
- Feasibility of first injection (Romiplostim or placebo) between 10 and 14 days before surgery
- Surgery requiring antiplatelet and/or anticoagulant therapy for at least 1 month postoperatively
You will not qualify if you...
- Inability to administer first injection within 10 days prior to surgery
- Cardiac surgery without cardiopulmonary bypass
- Coronary artery bypass grafting due to significant coronary stenoses
- Use of tangential filtration blood recovery system (i-SEP SAME�ae) or absence of intraoperative blood recovery system
- Planned use of aprotinin during surgery
- Contraindication to stopping all antiplatelet therapy before surgery
- Hereditary or acquired thrombophilia or history of thrombosis
- History of ischemic or hemorrhagic stroke
- History of phlebitis, pulmonary embolism, or portal vein thrombosis
- Heart attack with stent placement less than one year ago
- Current limb immobilization or inability to walk independently
- Malignant hematological disease or blast cells over 5%
- Malignant diseases with progressive last follow-up
- Severe chronic liver disease with CHILD-PUGH score above 6
- Treatment with thrombopoietin receptor agonist within 3 months
- Treatment with JAK2 inhibitor currently or within last month
- Treatment with Rituximab within last 7.5 months or intravenous immunoglobulin within last 40 days
- Ongoing corticosteroid treatment at high doses
- Known hemophilia
- Hypersensitivity to romiplostim or its components
- Conditions causing hyperchloremia, hypernatremia, or resistant anasarca
- Pregnant women or women of childbearing age without effective contraception
- Use of combined oral contraceptives or hormone replacement therapy containing estrogen
- Breastfeeding
- Minors
- Adults under guardianship, curatorship, or judicial protection
- Patients who do not speak French
- Patients without Social Security coverage
AI-Screening
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Trial Site Locations
Total: 8 locations
1
CHU d'Angers
Angers, France
Not Yet Recruiting
2
CHU de Bordeaux
Bordeaux, France
Not Yet Recruiting
3
CHU de Brest
Brest, France
Not Yet Recruiting
4
CHU de Dijon
Dijon, France
Not Yet Recruiting
5
CHU de Nantes
Nantes, France
Actively Recruiting
6
Hôpital Bichat (AP-HP)
Paris, France
Not Yet Recruiting
7
CHU de Rennes
Rennes, France
Not Yet Recruiting
8
CHU de Strasbourg
Strasbourg, France
Not Yet Recruiting
Research Team
J
Jean- Christophe RIGAL
CONTACT
A
Astrid GARREAU
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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