Diagnostic Role of Antiphospholipid Antibodies and Microparticles in Immune Thrombocytopenic Patients With Thrombosis
NCT ID: NCT05830916
Last Updated: 2023-04-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
70 participants
OBSERVATIONAL
2024-09-30
2027-09-30
Brief Summary
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Clinical implications of antiphospholipid antibodies in ITP patients with thrombosis.
Diagnostic role of microparticles in ITP patients with thrombosis.
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Detailed Description
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Recent studies showed that the occurrence of thrombosis in patients with ITP is not purely accidental and can be considered a clinical reality with an important impact on the management of the disease (2).
The pathophysiological mechanism for thrombosis in ITP remains unclear. Sever bleeding episodes are relatively rare in some patients with ITP although having low platelet count, suggests that these patients may have a protective factor against bleeding (3).
Antiphospholipid (aPL) antibodies are a heterogeneous group of autoantibodies with high affinity for phospholipids such lupus anticoagulant (LA), β2glycoprotien І (β2GPІ), and anticardiolipin (anti-CL). They interfere with physiological mechanisms of coagulation and fibrinolysis, leading the haemostatic balance towards coagulation. Moreover, it seems to affect the physiological function of various cells such as platelets and endothelial cells (4).
Microparticles (MPs) are a diverse group of bioactive small-sized vesicles (100-1000nm) that can be found in body fluids and blood after activation, necrosis, or apoptosis of almost all cells. Although most MPs in human blood originate from platelets, MPs are also released from leukocytes, erythrocytes, endothelial cells, smooth muscle cells and cancer cells (5). They participate in intercellular communication and play a major role in homeostasis under physiological conditions and also in diseases (6). The most prominent property of MPs is their procoagulant potential, mainly based on phosphatidylserine exposure and tissue factor expression (7).
Elevated levels of antiphospholipid antibodies and microparticles have been reported as a risk for development of prothrombotic state (8).
Conditions
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Study Design
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CASE_CROSSOVER
CROSS_SECTIONAL
Study Groups
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ITP with thrombosis
History taking including any medical history, family history, drug intake, arterial or venous thrombotic events.
Venous blood samples will be collected by vein puncture under aseptic precautions for:
Routine laboratory investigations:
Complete blood picture with assessment of platelet count. Coagulation tests including prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen and D-dimer.
Liver and Kidney functions test.
Specific laboratory investigations:
Antiphospholipid antibodies assay which includes:
Lupus anticoagulant (LA) by diluted Russel viper venom method. Anti β2glycoprotien І (β2GPІ), by enzyme-linked immunosorbent assay (ELISA). Anticardiolipin by (ELISA).
Detection of Microparticles and their subtypes by flow cytometry:
Annexin-v for all microparticles. CD 41 for platelet microparticles. CD 146 for endothelial microparticles.
Antiphospholipid antibodies
Antiphospholipid (aPL) antibodies are a heterogeneous group of autoantibodies with high affinity for phospholipids such lupus anticoagulant (LA), β2glycoprotien І (β2GPІ), and anticardiolipin (anti-CL). They interfere with physiological mechanisms of coagulation and fibrinolysis, leading the haemostatic balance towards coagulation. Moreover, it seems to affect the physiological function of various cells such as platelets and endothelial cells
ITP without thrombosis
History taking including any medical history, family history, drug intake, arterial or venous thrombotic events.
Venous blood samples will be collected by vein puncture under aseptic precautions for:
Routine laboratory investigations:
Complete blood picture with assessment of platelet count. Coagulation tests including prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen and D-dimer.
Liver and Kidney functions test.
B- Specific laboratory investigations:
Antiphospholipid antibodies assay which includes:
Lupus anticoagulant (LA) by diluted Russel viper venom method. Anti β2glycoprotien І (β2GPІ), by enzyme-linked immunosorbent assay (ELISA). Anticardiolipin by (ELISA).
Detection of Microparticles and their subtypes by flow cytometry:
Annexin-v for all microparticles. CD 41 for platelet microparticles. CD 146 for endothelial microparticles.
Antiphospholipid antibodies
Antiphospholipid (aPL) antibodies are a heterogeneous group of autoantibodies with high affinity for phospholipids such lupus anticoagulant (LA), β2glycoprotien І (β2GPІ), and anticardiolipin (anti-CL). They interfere with physiological mechanisms of coagulation and fibrinolysis, leading the haemostatic balance towards coagulation. Moreover, it seems to affect the physiological function of various cells such as platelets and endothelial cells
Interventions
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Antiphospholipid antibodies
Antiphospholipid (aPL) antibodies are a heterogeneous group of autoantibodies with high affinity for phospholipids such lupus anticoagulant (LA), β2glycoprotien І (β2GPІ), and anticardiolipin (anti-CL). They interfere with physiological mechanisms of coagulation and fibrinolysis, leading the haemostatic balance towards coagulation. Moreover, it seems to affect the physiological function of various cells such as platelets and endothelial cells
Eligibility Criteria
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Exclusion Criteria
Patients full fill the criteria of antiphospholipid syndrome (APS).
18 Years
70 Years
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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SONagi
doctor
Central Contacts
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References
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Rodeghiero F. ITP and thrombosis: an intriguing association. Blood Adv. 2017 Nov 14;1(24):2280. doi: 10.1182/bloodadvances.2017007989. eCollection 2017 Nov 14. No abstract available.
Boulware R, Refaai MA. Why do patients with immune thrombocytopenia (ITP) experience lower bleeding events despite thrombocytopenia? Thromb Res. 2020 Mar;187:154-158. doi: 10.1016/j.thromres.2020.01.020. Epub 2020 Jan 15.
Tomasello R, Giordano G, Romano F, Vaccarino F, Siragusa S, Lucchesi A, Napolitano M. Immune Thrombocytopenia in Antiphospholipid Syndrome: Is It Primary or Secondary? Biomedicines. 2021 Sep 6;9(9):1170. doi: 10.3390/biomedicines9091170.
Reid VL, Webster NR. Role of microparticles in sepsis. Br J Anaesth. 2012 Oct;109(4):503-13. doi: 10.1093/bja/aes321. Epub 2012 Sep 4.
Nomura S, Shimizu M. Clinical significance of procoagulant microparticles. J Intensive Care. 2015 Jan 7;3(1):2. doi: 10.1186/s40560-014-0066-z. eCollection 2015.
Chaturvedi S, Cockrell E, Espinola R, Hsi L, Fulton S, Khan M, Li L, Fonseca F, Kundu S, McCrae KR. Circulating microparticles in patients with antiphospholipid antibodies: characterization and associations. Thromb Res. 2015 Jan;135(1):102-8. doi: 10.1016/j.thromres.2014.11.011. Epub 2014 Nov 15.
Alvarez-Roman MT, Fernandez-Bello I, Jimenez-Yuste V, Martin-Salces M, Arias-Salgado EG, Rivas Pollmar MI, Justo Sanz R, Butta NV. Procoagulant profile in patients with immune thrombocytopenia. Br J Haematol. 2016 Dec;175(5):925-934. doi: 10.1111/bjh.14412. Epub 2016 Oct 21.
Other Identifiers
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Thrombosis in ITP
Identifier Type: -
Identifier Source: org_study_id
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