Prognostic Value of CD Markers in Immune Thrombocytopenic Purpura

NCT04311593 | Unknown

• 1 other identifier: CD markers in ITP
• Study Type: observational
• Target: 68
• Locations: 0 countries
• Sites: N/A

Brief Summary

In this study, we will focus on the independent prognostic relevance of the expressions of CD38, CD4, CD56, CD11b and CD19 markers in immune cells with platelet changes in patients with newly diagnosed and chronic ITP.

Conditions

Immune Thrombocytopenia

Outcome Measures

Primary Outcomes (1)

• measuring level of research CD markers in immue cells

  in acute ITP patients : at time of diagnosis and after treatment and return of platelets count to normal count. in chronic ITP patients : measuring of research CD markers once.

  one year

Study Arms (3)

group 1

control group with normal platelet count

Diagnostic Test: CD4, CD19, CD38, CD56 and CD11b

group 2

patients with acute ITP

Diagnostic Test: CD4, CD19, CD38, CD56 and CD11b

group 3

patients with chronic ITP

Diagnostic Test: CD4, CD19, CD38, CD56 and CD11b

Interventions

CD4, CD19, CD38, CD56 and CD11b DIAGNOSTIC_TEST

measuring CD markers by flowcytometry

group 1; group 2; group 3

Eligibility Criteria

• Age: 2 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Assiut university hospital - clinical hematology unit.

You may qualify if:

• Patients with thrombocytopenia were identified by their medical records. According to guidelines for the investigation and management of ITP, its diagnosis in thrombocytopenic patients was based on the following criteria: the presence of thrombocytopenia (platelet counts \<100 9 103/lL), patient's history, physical examination, normal concentration of hemoglobin and white blood cells (WBC), PB smear examination, normal or increased number of megakaryocytes with normal myeloid and erythroid progenitors in bone marrow (BM) smears. The absence of other diseases causing thrombocytopenia, including HIV and hepatitis C infection, SLE, aplastic anemia, megaloblastic anemia, and lymphoproliferative disorders was confirmed by BM aspiration assays. In chronic ITP : ITP patients lasting for more than 12 months

You may not qualify if:

• The prescence of other diseases causing thrombocytopenia, including HIV and hepatitis C infection, SLE, aplastic anemia, megaloblastic anemia and lymphoproliferative disorders was confirmed by BM aspiration assays

Sponsors & Collaborators

• Assiut University: lead

Related Publications (3)

• Provan D, Stasi R, Newland AC, Blanchette VS, Bolton-Maggs P, Bussel JB, Chong BH, Cines DB, Gernsheimer TB, Godeau B, Grainger J, Greer I, Hunt BJ, Imbach PA, Lyons G, McMillan R, Rodeghiero F, Sanz MA, Tarantino M, Watson S, Young J, Kuter DJ. International consensus report on the investigation and management of primary immune thrombocytopenia. Blood. 2010 Jan 14;115(2):168-86. doi: 10.1182/blood-2009-06-225565. Epub 2009 Oct 21.

  PMID: 19846889 BACKGROUND

• Stasi R. Pathophysiology and therapeutic options in primary immune thrombocytopenia. Blood Transfus. 2011 Jul;9(3):262-73. doi: 10.2450/2010.0080-10. Epub 2010 Nov 26. No abstract available.

  PMID: 21251458 BACKGROUND

• Namdev R, Dutta SR, Singh H. Acute immune thrombocytopenic purpura triggered by insect bite. J Indian Soc Pedod Prev Dent. 2009 Jan-Mar;27(1):58-61. doi: 10.4103/0970-4388.50821.

  PMID: 19414977 BACKGROUND

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

CD4 Lymphocyte Count

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

Intervention Hierarchy (Ancestors)

Lymphocyte Count; Leukocyte Count; Blood Cell Count; Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Essam ELdeen abdmohsen mohammed, Professor

  +201001971906

  STUDY DIRECTOR

Central Study Contacts

esraa ahmed mahmoud, resident doctor

CONTACT

+201011783088; dresraaahmed@gmail.com

rania mohammed mahmoud, assistant prof.

CONTACT

+201000019198

Study Design

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

Study Record Dates

• First Submitted: March 14, 2020
• First Posted: March 17, 2020
• Study Start: May 1, 2020
• Primary Completion: May 1, 2021
• Study Completion: August 1, 2021
• Last Updated: March 17, 2020

Record last verified: 2020-03