Diagnostic Role of Antiphospholipid Antibodies and Microparticles in Immune Thrombocytopenic Patients With Thrombosis

Thrombosis Clinical Trial

Official title:

Diagnostic Role of Antiphospholipid Antibodies and Microparticles in Immune Thrombocytopenic Patients With Thrombosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05830916
• Other study ID #: Thrombosis in ITP
• Status: Not yet recruiting
• Start date: September 2024
• Est. completion date: September 2027

Study information

• Verified date: April 2023
• Source: Assiut University
• Contact: Sarah Omer Nagi, Assiatant lecturer
• Phone: 01153399098
• Email: sarah_med99[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Identify the procoagulant profile in immune thrombocytopenic patients with thrombosis.

Clinical implications of antiphospholipid antibodies in ITP patients with thrombosis.

Diagnostic role of microparticles in ITP patients with thrombosis.

Description:

Immune thrombocytopenia (ITP) is an acquired autoimmune disorder characterized by isolated thrombocytopenia and an increased risk of bleeding. Paradoxically, ITP is also associated with an increased risk of thrombosis (1).

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: September 2027
• Est. primary completion date: September 2026
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Patients with confirmed diagnosis of primary chronic ITP with and without thrombosis, male or female above age of 18.Inclusion Criteria:

Exclusion Criteria:

Thrombocytopenic patients due to secondary causes such as pregnant women, patients with uncontrolled hypertension, peripheral or coronary artery disease, abnormal hepatic or renal function tests, bleeding disorder, and thrombopathy well be excluded from the study.

Patients full fill the criteria of antiphospholipid syndrome (APS).

Related Conditions & MeSH terms

• Thrombosis

Intervention

Diagnostic Test:
• Antiphospholipid antibodies
Antiphospholipid (aPL) antibodies are a heterogeneous group of autoantibodies with high affinity for phospholipids such lupus anticoagulant (LA), ß2glycoprotien ? (ß2GP?), 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identify the procoagulant profile in immune thrombocytopenic patients with thrombosis.	Clinical implications of antiphospholipid antibodies in ITP patients with thrombosis.; Diagnostic role of microparticles in ITP patients with thrombosis.	2 years