Role of Acute Phase Proteins In Diagnosis of Immune Thrombocytopenia

NCT ID: NCT06715215

Last Updated: 2024-12-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-15
• Study Completion Date: 2026-12-30

Brief Summary

Immune thrombocytopenia (ITP) are antibody-mediated disorders in which platelets are destroyed mainly through activating immunoglobulin (IgG) Fc receptors on phagocytes in the spleen and liver, eventually resulting in thrombocytopenia Acute phase proteins (APP) are inflammation markers that exhibit significant changes in serum concentration during inflammation. These are also important mediators produced in the liver during acute and chronic inflammatory states. Acute phase reactants can be classified as positive or negative, depending on their serum concentrations during inflammation. Positive acute phase reactants are upregulated, and their concentrations increase during inflammation. Negative acute phase reactants are downregulated, and their concentrations decrease during inflammation. Positive acute phase proteins include procalcitonin, C-reactive protein, ferritin, fibrinogen, hepcidin, and serum amyloid A. Negative acute phase reactants include albumin, prealbumin, transferrin, retinol-binding protein, and antithrombin CRP is now well established as a major acute phase protein and is used in daily clinical practice as a sensitive biomarker for infection and inflammation, with its level increasing from <0.05 to >500 mg/L after acute infections. CRP is produced by hepatocytes, in response to inflammatory cytokines such as interleukin (IL)-6 and IL-1, with serum concentrations rising to >5 mg/L after 6 hours and peaking after ∼48 hours. In healthy young adult volunteer blood donors, the median concentration of CRP was found to be ∼0.8 mg/L CRP levels are useful as a clinical diagnostic tool for infection, and it is a common knowledge that ITP is triggered by viral infection that precedes the clinical picture of ITP by a few days to a few weeks Procalcitonin (PCT) is used as a reliable inflammatory biomarker with high sensitivity and specificity ferritin was confirmed as an inflammation and infection biomarker in the diagnosis of viral and bacterial infections.

Conditions

Immune Thrombocytopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

age and sex matched thrombocytopenic patients other than ITP.

Causes of decreased platelets count other than immune thrombocytopenia

Group Type: ACTIVE_COMPARATOR

Acute phase proteins

Intervention Type: DIAGNOSTIC_TEST

Assessment of acute phase proteins levels in patients diagnosed with immune thrombocytopenia

acute ITP patients

Patients diagnosed as acute thrombocytopenia

Group Type: ACTIVE_COMPARATOR

Acute phase proteins

Intervention Type: DIAGNOSTIC_TEST

Assessment of acute phase proteins levels in patients diagnosed with immune thrombocytopenia

chronic ITP patients .

Patients diagnosed as chronic thrombocytopenia

Group Type: ACTIVE_COMPARATOR

Acute phase proteins

Intervention Type: DIAGNOSTIC_TEST

Assessment of acute phase proteins levels in patients diagnosed with immune thrombocytopenia

Interventions

Acute phase proteins

Assessment of acute phase proteins levels in patients diagnosed with immune thrombocytopenia

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Patients with platelet less than 100 × 109/L diagnosed as immune thrombocytopenia by bone marrow findings .

Age of patients : from 1 year to 50 years.

Exclusion Criteria

• - Other causes of thrombocytopenia as:

• Hypersplenism.
• Bone marrow diseases including : aplastic anemia, leukemia and myelodysplastic syndromes.
• Cancer treatments like chemotherapy and radiation therapy.
• Exposure to toxic chemicals as arsenic and benzene.
• Medications to treat bacterial infections (antibiotics)and treat seizures or blood thinner heparin.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Rana Mohamed Abdelhameed

Resident of clinical pathology department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sohag university hospital

Sohag, Sahag, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Rana M Abd Elhameed, Resident

Role: CONTACT

rana_mohamed_post@med.sohag.edu.eg

01070198923

Eman H Ali, Assistant Professor

Role: CONTACT

Facility Contacts

Magdy M Ameen, Professor

Role: primary

References

Gruys E, Toussaint MJ, Niewold TA, Koopmans SJ. Acute phase reaction and acute phase proteins. J Zhejiang Univ Sci B. 2005 Nov;6(11):1045-56. doi: 10.1631/jzus.2005.B1045.

Reference Type: BACKGROUND

PMID: 16252337 (View on PubMed)

Zeller B, Rajantie J, Hedlund-Treutiger I, Tedgard U, Wesenberg F, Jonsson OG, Henter JI; NOPHO ITP. Childhood idiopathic thrombocytopenic purpura in the Nordic countries: epidemiology and predictors of chronic disease. Acta Paediatr. 2005 Feb;94(2):178-84. doi: 10.1111/j.1651-2227.2005.tb01887.x.

Reference Type: BACKGROUND

PMID: 15981751 (View on PubMed)

Semple JW, Italiano JE Jr, Freedman J. Platelets and the immune continuum. Nat Rev Immunol. 2011 Apr;11(4):264-74. doi: 10.1038/nri2956.

Reference Type: BACKGROUND

PMID: 21436837 (View on PubMed)

Sullivan PS, Hanson DL, Chu SY, Jones JL, Ciesielski CA. Surveillance for thrombocytopenia in persons infected with HIV: results from the multistate Adult and Adolescent Spectrum of Disease Project. J Acquir Immune Defic Syndr Hum Retrovirol. 1997 Apr 1;14(4):374-9. doi: 10.1097/00042560-199704010-00011.

Reference Type: BACKGROUND

PMID: 9111481 (View on PubMed)

Other Identifiers

Soh-Med-24-11-13MS

Identifier Type: -

Identifier Source: org_study_id