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

April 25, 2023 updated by: SONagi, Assiut University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Observational

Enrollment (Anticipated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.
Diagnostic test: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identify the procoagulant profile in immune thrombocytopenic patients with thrombosis.
Time Frame: 2 years

Clinical implications of antiphospholipid antibodies in ITP patients with thrombosis.

Diagnostic role of microparticles in ITP patients with thrombosis.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2024

Primary Completion (Anticipated)

September 1, 2026

Study Completion (Anticipated)

September 1, 2027

Study Registration Dates

First Submitted

April 14, 2023

First Submitted That Met QC Criteria

April 25, 2023

First Posted (Actual)

April 26, 2023

Study Record Updates

Last Update Posted (Actual)

April 26, 2023

Last Update Submitted That Met QC Criteria

April 25, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Thrombosis in ITP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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