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

NCT05830916 | Not Yet Recruiting

• 1 other identifier: Thrombosis in ITP
• Study Type: observational
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Thrombosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Diagnostic Test: Antiphospholipid antibodies

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.

Diagnostic Test: Antiphospholipid antibodies

Interventions

Antiphospholipid antibodies DIAGNOSTIC_TEST

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 with thrombosis; ITP without thrombosis

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will include 35 cases of ITP without thrombosis and 35 case of ITP with thrombosis. The sample size was calculated based on determining the main outcome variable using G\*power software 3.1.9.2. based on the following assumption: Main outcome variable is difference between procoagulant profile of ITP patients with and without thrombosis especially for levels of antiphospholipid antibodies and microparticles (9). Main statistical test is one-sided student t-test to detect the difference between groups.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Assiut University: lead

Related Publications (7)

• 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.

  PMID: 29296876 BACKGROUND

• 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.

  PMID: 32004875 BACKGROUND

• 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.

  PMID: 34572358 BACKGROUND

• 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.

  PMID: 22952169 BACKGROUND

• 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.

  PMID: 25705427 BACKGROUND

• 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.

  PMID: 25467081 BACKGROUND

• 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.

  PMID: 27766635 BACKGROUND

MeSH Terms

Conditions

Thrombosis

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Sarah Omer Nagi, Assiatant lecturer

CONTACT

01153399098; sarah_med99@yahoo.com

Amal Adel Rayan, Lecturer

CONTACT

01002286687; amaladel@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: April 14, 2023
• First Posted: April 26, 2023
• Study Start: September 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: April 26, 2023

Record last verified: 2023-04