Actively Recruiting
Preoperative Use of Romiplostim in Thrombocytopenic Patients Undergoing Cardiac Surgery A Phase 3, Multicenter Randomized Double-blinded Controlled Study
Led by Nantes University Hospital · Updated on 2026-04-06
136
Participants Needed
8
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of Romiplostim in adults with low platelet counts who are scheduled for cardiac surgery involving cardiopulmonary bypass. This phase 2, multicenter, randomized, double-blind study aims to determine whether Romiplostim can improve platelet levels before surgery, allowing safer procedures for patients with thrombocytopenia. The study is sponsored by Nantes University Hospital and focuses on enhancing preoperative patient management to reduce complications related to low platelet counts. Participants will be randomly assigned to receive either Romiplostim or a placebo injection under the skin. Dosage of Romiplostim depends on baseline platelet count, with injections given between 10 and 14 days before surgery. Surgery involves the use of a blood recovery system with centrifugation. Patients will be hospitalized within 15 days of the first injection and closely monitored for at least 10 days after surgery. During the study, participants will undergo clinical and biological monitoring to detect adverse events promptly. Researchers will measure the effectiveness of Romiplostim in increasing platelet counts by day 7, along with secondary outcomes like blood transfusions, bleeding volume, hemoglobin levels, infection rates, and mortality up to 28 days post-surgery. The total study duration includes preoperative treatment, surgery, and follow-up assessments to ensure patient safety and evaluate outcomes thoroughly.
CONDITIONS
Brief 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 using a blood recovery system with centrifugation (Cell Saver type) or equivalent
- First injection of Romiplostim or placebo feasible between 10 and 14 days before surgery
- Surgery requiring postoperative antiplatelet and/or anticoagulant therapy for at least one month
You will not qualify if you...
- Inability to administer the first injection within 10 days prior to surgery
- Cardiac surgery without cardiopulmonary bypass
- Coronary artery bypass grafting for significant coronary stenoses
- Use of tangential filtration blood recovery system (i-SEP SAME�ae type) or absence of blood recovery system intraoperatively
- 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
- Myelogram showing malignant hematological disease or blast cells over 5%
- Malignant disease with progression at last follow-up
- Severe chronic liver disease with CHILD-PUGH score over 6
- Treatment with thrombopoietin receptor agonist within 3 months before inclusion
- Current or recent treatment with JAK2 inhibitor, Rituximab, or intravenous immunoglobulin
- Ongoing corticosteroid treatment at specified high doses
- Known hemophilia
- Hypersensitivity to romiplostim or its components
- Conditions causing major water and salt retention resistant to treatment
- Pregnancy, breastfeeding, or women of childbearing age not using effective contraception
- Use of combined oral contraceptives or estrogen-containing hormone therapy
- Minors
- Adults under legal guardianship or protection
- Patients who do not speak French
- Patients without Social Security coverage
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Injection administered between 10 and 14 days before surgery
Participants receive injections of Romiplostim or placebo before cardiac surgery to increase platelet counts.
1 preoperative injection visit
Duration - Day of surgery and hospitalization period
Participants undergo scheduled cardiac surgery with cardiopulmonary bypass followed by immediate post-operative care.
Surgery day and postoperative hospital visits
Duration - Up to 28 days post-surgery
Participants are monitored for efficacy, bleeding, transfusions, and complications up to 28 days after surgery.
Multiple visits including Day 1, Day 7, and Day 28 assessments
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
A
Astrid GARREAU
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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