Intravenous Immunoglobulin plus oral prednisone or high-dose dexamethasone, for adults with immune thrombocytopenia (ITP) with moderate and severe bleeding: a randomized, multicentre trial (IVIORDEX).

Ki vehet részt

• Age ≥ 18 years ≤ 80 years
• Diagnosis of ITP whatever the duration of the disease (newly diagnosed or relapsed) according to the standard definition
• Platelet count ≤ 20 x 109/L
• Any cutaneous and/or any mucosal bleeding manifestations
• Affiliated to a social security regime
• Written consent from patient

Ki nem vehet részt

• Participation in another interventional study involving human participants or being in the exclusion period at the end of a previous study involving human participants
• Previous non-response to IVIg or DEX
• Treatment with prednisone (1 mg/kg per day) for more than 3 days
• Symptomatic COVID-19 disease
• Ongoing viral infection (uncontrolled HIV, Viral hepatitis, herpes, varicella, zona)
• Uncontrolled diabetes (Acido-cetosis)
• Ongoing severe infection
• Severe Renal insufficiency (DFG < 45 ml.min.1.73m2)
• Severe Cardiac insufficiency (FEVG < 30 %)
• Life-threatening bleeding defined as Intracranial hemorrhage and/or active organ bleeding (GI tract, urinary tract or menorrhagia with at least a 2 g/dl decrease of hemoglobin value from baseline)
• Psychotic state not yet controlled by treatment
• Inability or refusal to understand or refusal to sign the informed consent from study participation
• Persons deprived of their liberty by judicial or administrative decision
• Persons under legal protection (guardianship, curatorship)
• Pregnant or breastfeeding woman or ineffective contraception
• Ongoing anticoagulation treatment (Therapeutic Low molecular weight heparins (LMWHs), direct oral anticoagulants (DOACs) and vitamin K antagonists (VKAs))
• Any contraindications to the prescribed Ig IV or prednisone patent medicine and to Neofordex®