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

Comparison Study of Methyl Prdnisolone Versus Intravenous Dexamethazone in Severe Immune Thrombocytopenic Purpra

Sponsors

Lead Sponsor: Assiut University

Source 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

Overall Status Unknown status
Start Date June 30, 2017
Completion Date June 1, 2018
Primary Completion Date June 30, 2017
Study Type Observational
Primary Outcome
Measure Time Frame
Percentage of patients respond to intravenous dexamethazone compared to patients received intravenous methylprednisolone in severe immune thrombocytopenic purpra one year
Enrollment 100
Condition
Eligibility

Sampling Method: Probability Sample

Criteria:

Inclusion Criteria:

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

Exclusion Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Verification Date

June 2017

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Assiut University

Investigator Full Name: Hager mohammed

Investigator Title: assiut

Keywords
Has Expanded Access No
Condition Browse
Patient Data No
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov