An observational study in Thrombosis, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-04-26.
Sponsored by Assiut University · Observational
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.
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).
1,506 studies on the registry are indexed under Thrombosis; 238 are open to participants now.
This study's planned enrollment of 70 is below the median of 213 across 586 observational studies indexed under Thrombosis.
Browse Thrombosis studies →Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.
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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.
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).
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
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
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.
Time frame: 2 years
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Assiut University