Comparison Between Methyl Prednisolone and Intravenous Dexamethazone in Severe Immune Thrombocytopenic Purpra

• Conditions: Immune Thrombocytopenia

• Registration Number: NCT03183284
• Lead Sponsor: Assiut University

Brief Summary

Immune thrombocytopenic purpra(ITP) is an autoimmune thrombocytopenic syndrome characterized by decreased platelet count and increased risk of bleeding, primarily due to immunoglobulins G(IgG)autoantibodies opsonizing the individual's platelets,resulting in markedly enhanced Fc receptors(FcR)-mediated phagocytosis and destruction by macrophages in the reticuloendothelial system within spleen Severe ITP defined as :Patients who have clinically relevant bleeding that mean that patients have bleeding symptoms at presentation sufficient to mandate treatment,or occurrence of new bleeding symptoms requiring additional therapeutic intervention with a different platelet-enhancing agent or an increased dose.

Detailed Description

Immune thrombocytopenic purpra(ITP) is an autoimmune thrombocytopenic syndrome characterized by decreased platelet count and increased risk of bleeding, primarily due to immunoglobulins G(IgG)autoantibodies opsonizing the individual's platelets,resulting in markedly enhanced Fc receptors(FcR)-mediated phagocytosis and destruction by macrophages in the reticuloendothelial system within spleen Severe ITP defined as :Patients who have clinically relevant bleeding that mean that patients have bleeding symptoms at presentation sufficient to mandate treatment,or occurrence of new bleeding symptoms requiring additional therapeutic intervention with a different platelet-enhancing agent or an increased dose.Prednislone is the standard intial first-line therapy in naïve ITP patients.Prednislone is usually given at 0.5 to 2mg/kg until platelet count increase(\>30-50 \*10\^9/L )which may require several days to several weeks,however prednisone should be rapidly tapered after 4 weeks to avoid corticosteroid related complication. In a trial to shorten the duration and reduce adverse effects of corticosteroids treatment. Dexamethasone in a dose of 40mg/day has been administered for 4days (equivalent to\~400mg of prednisone per day) achieved 85% initial reponse and sustained response 50% of adult cases of ITP at 6 months follow up

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2017-05-14
• Status Verified: 2017-06
• Study First Submitted QC: 2017-06-08
• Last Update Submitted: 2017-06-08
• Study First Posted: 2017-06-12
• Last Update Posted: 2017-06-12
• Study Start: 2017-06-30
• Primary Completion: 2017-06-30
• Study Completion: 2018-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients were aged 18or older diagnosed as acute severe ITP presented with active bleeding for emergency treatment.

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Exclusion Criteria

• Any contraindications for steroid therapy (osteoprosis, uncontrolled diabetes or uncontrolled hypertension).

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients respond to intravenous dexamethazone compared to patients received intravenous methylprednisolone in severe immune thrombocytopenic purpra	one year