Role of Acute Phase Proteins In Diagnosis of Immune Thrombocytopenia

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.

Study Overview

• Status: Recruiting
• Conditions: Immune Thrombocytopenia
• Intervention / Treatment: Diagnostic test: Acute phase proteins

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rana M Abd Elhameed, Resident; Phone Number: 01070198923; Email: rana_mohamed_post@med.sohag.edu.eg
• Study Contact Backup: Name: Eman H Ali, Assistant Professor

Study Locations

• Egypt
  • Sahag
    • Sohag, Sahag, Egypt
      • Recruiting
      • Sohag University Hospital
      • Contact: Magdy M Ameen, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: age and sex matched thrombocytopenic patients other than ITP.; Causes of decreased platelets count other than immune thrombocytopenia	Diagnostic test: Acute phase proteins; Assessment of acute phase proteins levels in patients diagnosed with immune thrombocytopenia
Active Comparator: acute ITP patients; Patients diagnosed as acute thrombocytopenia	Diagnostic test: Acute phase proteins; Assessment of acute phase proteins levels in patients diagnosed with immune thrombocytopenia
Active Comparator: chronic ITP patients .; Patients diagnosed as chronic thrombocytopenia	Diagnostic test: Acute phase proteins; Assessment of acute phase proteins levels in patients diagnosed with immune thrombocytopenia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute phase proteins	By taking serum samples from pateints and measure acute phase proteins levels	2 years

Collaborators and Investigators

• Sponsor: Sohag University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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. Erratum In: J Acquir Immune Defic Syndr Hum Retrovirol 1997 May 1;15(1):94.

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2024
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: November 28, 2024
• First Submitted That Met QC Criteria: November 28, 2024
• First Posted (Estimated): December 4, 2024

Study Record Updates

• Last Update Posted (Estimated): December 4, 2024
• Last Update Submitted That Met QC Criteria: November 28, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cytopenia; Pathologic Processes; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Skin Manifestations; Hematologic Diseases; Blood Coagulation Disorders; Hemorrhagic Disorders; Blood Platelet Disorders; Thrombotic Microangiopathies; Purpura, Thrombocytopenic; Purpura; Thrombocytopenia; Purpura, Thrombocytopenic, Idiopathic
• Other Study ID Numbers: Soh-Med-24-11-13MS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No