Autologous Whole Blood Therapy in Chronic Idiopathic Urticaria Patients.
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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: Autologous whole blood therapy, Desloratadine.
- Who it may be relevant to
- Registry conditions: Chronic Idiopathic Urticaria. Basic parameters: from 18 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 →
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Official title
Autologous Whole Blood Therapy in Autologous Serum Skin Test (ASST) Positive and Negative Chronic Idiopathic Urticaria Patients, a Clinical and Biochemical Randomized Controlled Trial.
Overview
To evaluate the efficacy of Autologous Whole Blood Therapy versus conventional treatment using fourfold dose of antihistamines in Autologus serum skin test (ASST) positive and negative Chronic Idiopathic Urticaria (CIU) patients and suggest its possible mechanism of action.
Detailed description
To evaluate the efficacy of Autologous Whole Blood Therapy (AWBT) versus conventional treatment using fourfold dose of antihistamines in ASST positive and negative Chronic Idiopathic Urticaria (CIU) patients and suggest its possible mechanism of action. Also, assessment of serum levels of D-dimer, IFN-γ, IL-6, anti-IgE IgG before and after treatment.
All patients will take desloratadine 10 mg at four-fold dose daily The AWBT test group patients will receive 8 doses of autologous whole blood therapy (AWBT) once weekly. The first dose will be 2.5ml and subsequent doses will be 5ml of venous blood, which will be drawn from any accessible vein under aseptic precautions. The blood will be re-injected immediately by deep intramuscular injection (IM) on alternate gluteal regions.
Patients will be advised to record the 7-day urticaria activity score (UAS 7) based on a simple questionnaire, on day 0, 4th week and 8th week of the treatment (End of Therapy (EOT)), and in the follow up period after 4 weeks following EOT (End of Study (EOS)). Dermatology life quality index (DLQI) will be assessed before treatment and at the end of therapy (8 weeks).
Interventions
- Biological Autologous whole blood therapy
The AWBT test group patients will receive 8 doses of autologous whole blood therapy (AWBT) once weekly. The first dose will be 2.5ml and subsequent doses will be 5ml of venous blood, which will be drawn from any accessible vein under aseptic precautions. The blood will be re-injected immediately by deep intramuscular injection (IM) on alternate gluteal regions. - Drug Desloratadine
All patients will take desloratadine 10 mg at four-fold dose daily
Primary outcome measures
- change in urticaria activity score (UAS7) from baseline to 8 weeks [Time frame: 12 months]
Secondary outcome measures (2)
- correlation between ASST result and treatment response [Time frame: 12 months]
- correlation between serum biomarkers and treatment response [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
Chronic idiopathic urticaria patients of both sexes aging 18 years of age or older who are unresponsive to four-fold of antihistamines.
Exclusion criteria
- other types of chronic urticaria
- Pregnancy
- Lactation
- Immunocompromised patients
- Patients on Systemic corticosteroid or immunosuppressive drugs used in the past 6 weeks
- History of Bronchial Asthma
- Patients on anticoagulants
- Patients on non-steroidal anti-inflammatory drugs
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Faculty of Medicine, Cairo university — Cairo
Publications
- Kitsioulis NA, Xepapadaki P, Roussaki-Schulze AV, Papadopoulos N, Zafiriou E. Effectiveness of Autologous Whole-Blood Injections in Patients with Refractory Chronic Spontaneous Urticaria. Int Arch Allergy Immunol. 2017;172(3):161-166. doi: 10.1159/000458152. Epub 2017 Apr 6. PMID 28380487
- Kocaturk E, Aktas S, Turkoglu Z, Kavala M, Zindanci I, Koc M, Can B, Sudogan S. Autologous whole blood and autologous serum injections are equally effective as placebo injections in reducing disease activity in patients with chronic spontaneous urticaria: a placebo controlled, randomized, single-blind study. J Dermatolog Treat. 2012 Dec;23(6):465-71. doi: 10.3109/09546634.2011.593485. Epub 2011 Ju PMID 21801101
- Chen Q, Luo J, Yang X, Chen W, Liu W, Song Z. Biomarkers of Autologous Whole Blood Injection Efficacy in Patients with Chronic Spontaneous Urticaria with Autoreactivity: A Preliminary Study. Int Arch Allergy Immunol. 2024;185(2):190-195. doi: 10.1159/000534662. Epub 2023 Nov 10. PMID 37952519
Identifiers
NCT: NCT07486583 · MD-142-2025