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Recruiting NCT06715215

Role of Acute Phase Proteins In Diagnosis of Immune Thrombocytopenia

No phase Interventional Immune Thrombocytopenia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Acute phase proteins.
Who it may be relevant to
Registry conditions: Immune Thrombocytopenia. Basic parameters: 1 year — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Diagnostic test Acute phase proteins
    Assessment of acute phase proteins levels in patients diagnosed with immune thrombocytopenia

Primary outcome measures

  • Acute phase proteins [Time frame: 2 years]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Diagnostic

Study locations

Egypt · 1 center
  • Sohag university hospital — Sohag

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. PMID 16252337
  • 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
  • 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
  • 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

Identifiers

NCT: NCT06715215 · Soh-Med-24-11-13MS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗