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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
136
CHU d'Angers
Angers, France
CHU de Bordeaux
Bordeaux, France
CHU de Brest
Brest, France
CHU de Dijon
Dijon, France
CHU de Nantes
Nantes, France
Hôpital Bichat (AP-HP)
Paris, France
CHU de Rennes
Rennes, France
CHU de Strasbourg
Strasbourg, France
Efficacy
Lowest platelet count measured between the end of ECC and the 7th postoperative day with D0 = day of surgery
Time frame: Day 7
Transfusion of platelet concentrate
Number of transfusion of platelet concentrate
Time frame: Day 1
Transfusion of platelet concentrate
Number of transfusion of platelet concentrate
Time frame: Day 7
Transfusion of platelet concentrate
Number of transfusion of platelet concentrate
Time frame: Day 28
Transfusion of red blood cell concentrate
Number of transfusion of red blood cell concentrate
Time frame: Day 1
Transfusion of red blood cell concentrate
Number of transfusion of red blood cell concentrate
Time frame: Day 7
Transfusion of red blood cell concentrate
Number of transfusion of red blood cell concentrate
Time frame: Day 28
Transfusion of fresh frozen plasma
Number of transfusion of fresh frozen plasma
Time frame: Day 1
Transfusion of fresh frozen plasma
Number of transfusion of fresh frozen plasma
Time frame: Day 7
Administration of blood-derived drugs
Number of administration of blood-derived drugs
Time frame: Day 1
Administration of blood-derived drugs
Number of administration of blood-derived drugs
Time frame: Day 7
Administration of blood-derived drugs
Number of administration of blood-derived drugs
Time frame: Day 28
Efficacy
Lowest platelet count measured between the end of ECC and the 28th postoperative day with D0 = day of surgery
Time frame: Day 28
Efficacy
Highest platelet count measured between the end of ECC and the 7th postoperative day with D0 = day of surgery
Time frame: Day 7
Efficacy
Highest platelet count measured between the end of ECC and the 28th postoperative day with D0 = day of surgery
Time frame: Day 28
Lowest haemoglobin
Lowest haemoglobincount measured between the end of ECC and the 7th postoperative day with D0 = day of surgery
Time frame: Day 7
Lowest haemoglobin
Lowest haemoglobincount measured between the end of ECC and the 28th postoperative day with D0 = day of surgery
Time frame: Day 28
Bleeding volume
Post-operative bleeding volume from sternal closure to 12th post-operative hour
Time frame: Hour 12
Bleeding volume
Post-operative bleeding volume from sternal closure to 24th post-operative hour
Time frame: Day 1
Mortality
Rate of mortality
Time frame: Day 28
Infection
Rate of infection
Time frame: Month 3
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