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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-517710-15-00 | EU Trial (CTIS) Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Romiplostim | Experimental | injection sc |
|
| NaCl | Placebo Comparator | injection sc |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nplate | Drug | The dosage for this first injection will be:
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy | Lowest platelet count measured between the end of ECC and the 7th postoperative day with D0 = day of surgery | Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Transfusion of platelet concentrate | Number of transfusion of platelet concentrate | Day 1 |
| Transfusion of platelet concentrate | Number of transfusion of platelet concentrate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jean- Christophe RIGAL | Contact | +33 240165304 | jeanchristophe.rigal@chu-nantes.fr | |
| Astrid GARREAU | Contact | astrid.garreau@chu-nantes.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU d'Angers | Not yet recruiting | Angers | France |
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| ID | Term |
|---|---|
| D013921 | Thrombocytopenia |
| ID | Term |
|---|---|
| D001791 | Blood Platelet Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000095542 | Cytopenia |
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| ID | Term |
|---|---|
| C488777 | romiplostim |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| NaCl %0.9 | Drug | NaCl (Sodium chloride) 0.9% administered subcutaneously |
|
| Day 7 |
| Transfusion of platelet concentrate | Number of transfusion of platelet concentrate | Day 28 |
| Transfusion of red blood cell concentrate | Number of transfusion of red blood cell concentrate | Day 1 |
| Transfusion of red blood cell concentrate | Number of transfusion of red blood cell concentrate | Day 7 |
| Transfusion of red blood cell concentrate | Number of transfusion of red blood cell concentrate | Day 28 |
| Transfusion of fresh frozen plasma | Number of transfusion of fresh frozen plasma | Day 1 |
| Transfusion of fresh frozen plasma | Number of transfusion of fresh frozen plasma | Day 7 |
| Administration of blood-derived drugs | Number of administration of blood-derived drugs | Day 1 |
| Administration of blood-derived drugs | Number of administration of blood-derived drugs | Day 7 |
| Administration of blood-derived drugs | Number of administration of blood-derived drugs | Day 28 |
| Efficacy | Lowest platelet count measured between the end of ECC and the 28th postoperative day with D0 = day of surgery | Day 28 |
| Efficacy | Highest platelet count measured between the end of ECC and the 7th postoperative day with D0 = day of surgery | Day 7 |
| Efficacy | Highest platelet count measured between the end of ECC and the 28th postoperative day with D0 = day of surgery | Day 28 |
| Lowest haemoglobin | Lowest haemoglobincount measured between the end of ECC and the 7th postoperative day with D0 = day of surgery | Day 7 |
| Lowest haemoglobin | Lowest haemoglobincount measured between the end of ECC and the 28th postoperative day with D0 = day of surgery | Day 28 |
| Bleeding volume | Post-operative bleeding volume from sternal closure to 12th post-operative hour | Hour 12 |
| Bleeding volume | Post-operative bleeding volume from sternal closure to 24th post-operative hour | Day 1 |
| Mortality | Rate of mortality | Day 28 |
| Infection | Rate of infection | Month 3 |
| CHU de Bordeaux | Not yet recruiting | Bordeaux | France |
|
| CHU de Brest | Not yet recruiting | Brest | France |
|
| CHU de Dijon | Not yet recruiting | Dijon | France |
|
| CHU de Nantes | Recruiting | Nantes | France |
|
| Hôpital Bichat (AP-HP) | Not yet recruiting | Paris | France |
|
| CHU de Rennes | Not yet recruiting | Rennes | France |
|
| CHU de Strasbourg | Not yet recruiting | Strasbourg | France |
|
| D017670 |
| Sodium Compounds |