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Clinical Trials/NCT06715215
NCT06715215RecruitingNot Applicable

Role of Acute Phase Proteins In Diagnosis of Immune Thrombocytopenia

Sohag University1 site in 1 country100 target enrollmentStarted: November 15, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
100
Locations
1
Primary Endpoint
Acute phase proteins

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
1 Year to 50 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

Acute phase proteins

Time Frame: 2 years

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Rana Mohamed Abdelhameed

Resident of clinical pathology department

Sohag University

Study Sites (1)

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