Role of Acute Phase Proteins In Diagnosis of Immune Thrombocytopenia

Sohag University

Status: Enrolling

Conditions: Immune Thrombocytopenia

Treatments: Diagnostic Test: Acute phase proteins

Study type: Interventional

Funder types: Other

Identifiers

NCT06715215

Soh-Med-24-11-13MS

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 1 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

age and sex matched thrombocytopenic patients other than ITP.

Active Comparator group

Description:

Causes of decreased platelets count other than immune thrombocytopenia

Treatment:

Diagnostic Test: Acute phase proteins

acute ITP patients

Active Comparator group

Description:

Patients diagnosed as acute thrombocytopenia

Treatment:

Diagnostic Test: Acute phase proteins

chronic ITP patients .

Active Comparator group

Description:

Patients diagnosed as chronic thrombocytopenia

Treatment:

Diagnostic Test: Acute phase proteins