COVID-19 Vaccine and Development of Immune Thrombocytopenic Purpura
NCT ID: NCT05455983
Last Updated: 2022-07-13
Study Results
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Basic Information
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UNKNOWN
500 participants
OBSERVATIONAL
2022-08-01
2023-12-01
Brief Summary
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Detailed Description
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The pathophysiology of ITP is uncertain; however, it is theorized that the acquired thrombocytopenia results from pathologic antiplatelet antibodies, impaired megakaryocytopoiesis, and T-cell-mediated destruction of platelets. ITP is primarily a diagnosis of exclusion, and the main characteristic of the disease is an increased peripheral destruction of platelets, the majority of patients showing anti-platelet membrane glycoproteins antibodies.
Patients may be asymptomatic at presentation or they may present with mild mucocutaneous to life-threatening bleeding, the intracranial one presenting the highest risk, Mortality by hemorrhage is 5% of cases.
The recent global pandemic of coronavirus disease 2019 (COVID-19) has led to vaccination in many parts of the world for herd immunity, and as vaccination has progressed, several rare adverse events have been reported. ITP has been associated with several types of vaccinations. Vaccine-related thrombocytopenia is considered to be of immune origin because antibodies can be detected on platelets in about 79% of cases. Various reports have shown that all of the live, attenuated viruses in the measles, mumps, and rubella (MMR) vaccine can cause ITP. Past studies have shown that the risk of developing ITP also increases after the administration of hepatitis A, varicella, and diphtheria-tetanus-pertussis vaccines in children and adolescents. Recently, a few case reports have shown a temporal relationship between receiving the coronavirus disease 2019 (COVID-19) vaccine and developing ITP of varying severity.
The Vaccine Adverse Effect Reporting System (VAERS) is a passive, voluntary reporting system that collects reports of adverse events associated with vaccination. VAERS reports can be submitted voluntarily by anyone, including healthcare providers, patients, or family members. A review of VAERS data has revealed 22 reports of thrombocytopenia and 13 reports of ITP following COVID-19 vaccine administration. However, underreporting is one of the main limitations of passive surveillance systems including VAERS, and it is possible that the true number of cases is far higher, especially considering that most cases of ITP are asymptomatic.
It is impossible to strictly differentiate between vaccine-induced secondary ITP and incidental primary ITP that occurred soon after vaccination. However, of the cases identified so far, 22 occurred after the first vaccination and only one after the second vaccination. Since the frequencies of occurrence are highly uneven, there is likely to be a causal relationship between the COVID-19 vaccine and the development of ITP. Lee et al. also reported that symptoms of bleeding occurred between 1 and 23 days (median 5 days) after vaccine administration.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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covid19 vaccines
different types of (COVID-19) vaccination
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Patients with other possible causes of thrombocytopenia
3. Patients with autoimmune disorders
17 Years
60 Years
ALL
Yes
Sponsors
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Assiut University
OTHER
Responsible Party
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Shymaa Mohamed Ismail
doctor
Principal Investigators
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Ahmed F Thabet, Professor
Role: STUDY_DIRECTOR
Assiut University
Rania M Hafez, Assist. Prof
Role: STUDY_CHAIR
Assiut University
Shymaa M Ismail, Doctor
Role: PRINCIPAL_INVESTIGATOR
Assiut University
Locations
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Egypt
Asyut, , Egypt
Countries
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Central Contacts
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Facility Contacts
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References
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Provan D, Arnold DM, Bussel JB, Chong BH, Cooper N, Gernsheimer T, Ghanima W, Godeau B, Gonzalez-Lopez TJ, Grainger J, Hou M, Kruse C, McDonald V, Michel M, Newland AC, Pavord S, Rodeghiero F, Scully M, Tomiyama Y, Wong RS, Zaja F, Kuter DJ. Updated international consensus report on the investigation and management of primary immune thrombocytopenia. Blood Adv. 2019 Nov 26;3(22):3780-3817. doi: 10.1182/bloodadvances.2019000812.
Kistangari G, McCrae KR. Immune thrombocytopenia. Hematol Oncol Clin North Am. 2013 Jun;27(3):495-520. doi: 10.1016/j.hoc.2013.03.001.
El Ghannam D, Fawzy IM, Azmy E, Hakim H, Eid I. Relation of interleukin-10 Promoter Polymorphisms to Adult Chronic Immune Thrombocytopenic Purpura in a Cohort of Egyptian Population. Immunol Invest. 2015;44(7):616-26. doi: 10.3109/08820139.2015.1064948.
Julian JA, Mathern DR, Fernando D. Idiopathic Thrombocytopenic Purpura and the Moderna Covid-19 Vaccine. Ann Emerg Med. 2021 Jun;77(6):654-656. doi: 10.1016/j.annemergmed.2021.02.011. Epub 2021 Feb 12. No abstract available.
Cortelazzo S, Finazzi G, Buelli M, Molteni A, Viero P, Barbui T. High risk of severe bleeding in aged patients with chronic idiopathic thrombocytopenic purpura. Blood. 1991 Jan 1;77(1):31-3.
Cecinati V, Principi N, Brescia L, Giordano P, Esposito S. Vaccine administration and the development of immune thrombocytopenic purpura in children. Hum Vaccin Immunother. 2013 May;9(5):1158-62. doi: 10.4161/hv.23601. Epub 2013 Jan 16.
Du J, Xiang Y, Sankaranarayanapillai M, Zhang M, Wang J, Si Y, Pham HA, Xu H, Chen Y, Tao C. Extracting postmarketing adverse events from safety reports in the vaccine adverse event reporting system (VAERS) using deep learning. J Am Med Inform Assoc. 2021 Jul 14;28(7):1393-1400. doi: 10.1093/jamia/ocab014.
Other Identifiers
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COVID-19 and ITP
Identifier Type: -
Identifier Source: org_study_id
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