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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AWBT plus antihistamines | Experimental | 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. |
|
| antihistamines alone | Active Comparator | All patients will take desloratadine 10 mg at four-fold dose daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous whole blood therapy | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| change in urticaria activity score (UAS7) from baseline to 8 weeks | Change in 7-day urticaria activity score (UAS7) score from baseline to 8 weeks after treatment with either AWBT with fourfold antihistamines or fourfold of antihistamines alone in Chronic Idiopathic Urticaria (CIU) patients. urticaria activity score7 ranges from 0-42. A score of 0 means complete remission while score (28-42) means severe disease | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| correlation between ASST result and treatment response | correlation between autologous serum skin test (ASST) result (positive/negative) and change in UAS7 score after 8 weeks of treatment. ASST positivity will be assessed as a binary variable(positive/negative), and treatment response will be measured as the change in UAS7 | 12 months |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah Elsayed, MSc, MBBCh | Contact | 00201094077370 | sarahelsaid651@gmail.com | |
| Ahmed Mourad, MD | Contact | 00201021534245 | ahmedmourad@kasralainy.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine, Cairo university | Cairo | Cairo Governorate | 11553 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28380487 | Background | 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. | |
| 21801101 | Background | 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 Jul 31. |
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Relevant participant data shall be provided to researchers who request them on reasonable basis
from January 2027 indefinitely
access will be provided to deidentified data including all study parameters
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| ID | Term |
|---|---|
| D000080223 | Chronic Urticaria |
| ID | Term |
|---|---|
| D014581 | Urticaria |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C121345 | desloratadine |
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| Desloratadine | Drug | All patients will take desloratadine 10 mg at four-fold dose daily |
|
| correlation between serum biomarkers and treatment response |
correlation between baseline serum levels of interferon-gamma (IFN-γ), interleukin-6(IL-6) and anti-IgE IgG antibodies and change in UAS7 score after 8 weeks of treatment. serum biomarkers will be measured using ELISA and expressed in pg/ml (for IFN-γ, IL-6) and optical density or concentration units for anti-IgE IgG. |
| 12 months |
| 37952519 | Background | 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. |
| D006969 |
| Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |