ThrombosisNCT05830916
Diagnostic Role of Antiphospholipid Antibodies and Microparticles in Immune Thrombocytopenic Patients With Thrombosis
An observational study of Thrombosis, run by Assiut University.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Thrombosis
- What is being tested?
- Antiphospholipid antibodies
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Sep 2024to Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
None listed.
Who cannot join
- 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).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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).
- Conditions
- Thrombosis
- Being tested
- Antiphospholipid antibodies
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antiphospholipid antibodiesDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Antiphospholipid antibodies |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study startSep 2024 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for ThrombosisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SONagi, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05830916
- Sponsor's protocol ID
- Thrombosis in ITP
- Status last verified
- Apr 2023
- First submitted
- 14 Apr 2023
- Last updated
- 26 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29296876Boulware 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.
PubMed 32004875Tomasello 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.
PubMed 34572358Reid 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.
PubMed 22952169Nomura 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.
PubMed 25705427Chaturvedi 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.
PubMed 25467081Alvarez-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.
PubMed 27766635
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Role of Antiphospholipid Antibodies and Microparticles in Immune Thrombocytopenic Patients With Thrombosis
- ClinicalTrials.gov ID
- NCT05830916
- Acronym / sponsor ID
- Thrombosis in ITP
- Conditions
- Thrombosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 26 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ITP with thrombosis | – | Diagnostic Test: Antiphospholipid antibodiesHistory 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. |
| ITP without thrombosis | – | Diagnostic Test: Antiphospholipid antibodiesHistory 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antiphospholipid antibodiesAntiphospholipid (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 | Diagnostic test | ITP with thrombosis, ITP without thrombosis |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
- Background: PubMed 29296876Rodeghiero 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.
- Background: PubMed 32004875Boulware 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.
- Background: PubMed 34572358Tomasello 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.
- Background: PubMed 22952169Reid 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.
- Background: PubMed 25705427Nomura 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.
- Background: PubMed 25467081Chaturvedi 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.
- Background: PubMed 27766635Alvarez-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Thrombosis, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Omer Nagi, Assiatant lecturer (01153399098, sarah_med99@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify the procoagulant profile in immune thrombocytopenic patients with thrombosis. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05830916, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2023.