Role of Acute Phase Proteins In Diagnosis of Immune Thrombocytopenia

NCT06715215 | Recruiting

• 1 other identifier: Soh-Med-24-11-13MS
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Acute phase proteins

  By taking serum samples from pateints and measure acute phase proteins levels

  2 years

Study Arms (3)

age and sex matched thrombocytopenic patients other than ITP.

ACTIVE COMPARATOR

Causes of decreased platelets count other than immune thrombocytopenia

Diagnostic Test: Acute phase proteins

acute ITP patients

ACTIVE COMPARATOR

Patients diagnosed as acute thrombocytopenia

Diagnostic Test: Acute phase proteins

chronic ITP patients .

ACTIVE COMPARATOR

Patients diagnosed as chronic thrombocytopenia

Diagnostic Test: Acute phase proteins

Interventions

Acute phase proteins DIAGNOSTIC_TEST

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

acute ITP patients; age and sex matched thrombocytopenic patients other than ITP.; chronic ITP patients .

Eligibility Criteria

• Age: 1 Year - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag university hospital

Sohag, Sahag, Egypt

RECRUITING

Related Publications (4)

• 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.

  PMID: 16252337 BACKGROUND

• 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.

  PMID: 15981751 BACKGROUND

• 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.

  PMID: 21436837 BACKGROUND

• 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.

  PMID: 9111481 BACKGROUND

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

Central Study Contacts

Rana M Abd Elhameed, Resident

CONTACT

01070198923; rana_mohamed_post@med.sohag.edu.eg

Eman H Ali, Assistant Professor

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of clinical pathology department

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: December 4, 2024
• Study Start: November 15, 2024
• Primary Completion: December 30, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: December 4, 2024

Record last verified: 2024-11

Locations

EG (1)