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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03183284
Enrollment
100
Registered
2017-06-12
Start date
2017-06-30
Completion date
2018-06-01
Last updated
2017-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immune Thrombocytopenia

Keywords

dexamethazone, prednislone, severe ITP

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

Interventions

None listed

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frame
Percentage of patients respond to intravenous dexamethazone compared to patients received intravenous methylprednisolone in severe immune thrombocytopenic purpraone year

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026