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

NCT03183284 | Unknown DMC

• 1 other identifier: Hager2791
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Immune Thrombocytopenia

Keywords

dexamethazone; prednislone; severe ITP

Outcome Measures

Primary Outcomes (1)

• Percentage of patients respond to intravenous dexamethazone compared to patients received intravenous methylprednisolone in severe immune thrombocytopenic purpra

  one year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients will be recruited in each group of therapy IV dexamethasone 40 mg/ day for 4 days versus IV methyl prednisolone 1 gm/day for 3 days.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assiut

Study Record Dates

• First Submitted: May 14, 2017
• First Posted: June 12, 2017
• Study Start: June 30, 2017
• Primary Completion: June 30, 2017
• Study Completion: June 1, 2018
• Last Updated: June 12, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share