Beta-ThalassemiaNCT04219449
Thrombophilia In Beta Thalassemia
An observational study of Beta-Thalassemia, run by Assiut University.
Trial summary
β-thalassemia disease is one of the most common congenital hemolytic anemia commonly found in the malarial belt areas including the Mediterranean, the Middle East, Africa, Southeast Asian countries, and China. Read more about this study
- Who is it for?
- Ages 4 to 20 years
- Conditions the study is for
- Beta-Thalassemia
- What is being tested?
- PT, Protein C and Platelet aggregation by ADP and arachidonic acid
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 7 May 2024to 31 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 4 to 20 years
- All sexes
- Child, Adult
Study population: Diagnosed beta-thalassemia patients attending Pediatric Hematology Outpatient Clinic at Assiut University Hospital.
Who may be able to join
- All blood samples from thalassemia patients before blood transfusion.
- In splenectomized patients taking Aspirin, the tests will be performed 7 days after discontinuation of the drug.
Who cannot join
- Patients with other hemoglobinopathies other than beta-thalassemia.
- Patients suffering from hepatic or cardiac dysfunctions of another aetiology.
- Patients with history of familial thrombophilia or use of anticoagulant therapy.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Thrombophilia Versus Platelet Dysfunction In Beta Thalassemia
β-thalassemia disease is one of the most common congenital hemolytic anemia commonly found in the malarial belt areas including the Mediterranean, the Middle East, Africa, Southeast Asian countries, and China.
Read the detailed description
β-thalassemia represents a major public health problem in Egypt, it is estimated that there are 1000/1.5 million per year live births born with β-thalassemia. The average life expectancy of patients with β-thalassemia has improved over the last few years as compared to that of in the previous millennium. This has led to the discovery of new set of problems such as increased hypercoagulable state in β-thalassemia like micro infarcts in spleen and lung indicating an activated coagulation pathway. The, incidence of thromboembolism in patients with thalassemia disease is approximately 10 times higher than normal population, it accounts between 1.7 and 9.2%. On the other hand, a study conducted by Chaudhary and Ahmad, 2012 showed decreased aggregation in majority of β-thalassemia patients. Another study conducted by Ibrahim, 1999 had noticed few patients to have bleeding manifestations in the form of epistaxis. Mussumeci et al., 1987 noted that both thrombophilic and anti-thrombophilic proteins were reduced as a consequence of liver damage. The net clinical outcome depends on the fine balance between the prothrombotic and antithrombotic pathways.
- Conditions
- Beta-Thalassemia
- Being tested
- PT, Protein C, Platelet aggregation by ADP and arachidonic acid
- Medical subject headings
- beta-Thalassemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTDiagnostic test
measuring PT drawn on citrated blood sample
Protein CDiagnostic test
measuring protein C drawn on citrated blood sample
Platelet aggregation by ADP and arachidonic acidDiagnostic test
measuring platelet aggregation drawn on citrated blood sample
| Study group | Role | What they receive |
|---|---|---|
| study group | Diagnosed beta-thalassemia patients at Assiut University Hospital. Receives: Diagnostic Test: PT; Diagnostic Test: Protein C; Diagnostic Test: Platelet aggregation by ADP and arachidonic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypercoagulability versus platelet dysfunction
Predominance of hypercoagulability versus platelet dysfunction in beta-thalassemia patients
Measured: one year
Secondary outcomes (1)
Regular screening of thalassemia patients
Evaluation of the significance of implementing regular screening of thalassemia patients for any possible hemostatic changes.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study start7 May 2024 (estimated)
- Primary completion30 May 2024 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Beta-ThalassemiaStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, IM Yousef, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04219449
- Sponsor's protocol ID
- TPDBT
- Status last verified
- May 2024
- First submitted
- 27 Dec 2019
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Winichakoon P, Tantiworawit A, Rattanathammethee T, Hantrakool S, Chai-Adisaksopha C, Rattarittamrong E, Norasetthada L, Charoenkwan P. Prevalence and Risk Factors for Complications in Patients with Nontransfusion Dependent Alpha- and Beta-Thalassemia. Anemia. 2015;2015:793025. doi: 10.1155/2015/793025. Epub 2015 Nov 18.
PubMed 26664743Cappellini MD, Motta I, Musallam KM, Taher AT. Redefining thalassemia as a hypercoagulable state. Ann N Y Acad Sci. 2010 Aug;1202:231-6. doi: 10.1111/j.1749-6632.2010.05548.x.
PubMed 20712798
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thrombophilia Versus Platelet Dysfunction In Beta Thalassemia
- ClinicalTrials.gov ID
- NCT04219449
- Acronym / sponsor ID
- TPDBT
- Conditions
- Beta-Thalassemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 7 May 2024 (estimated)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 7 Jan 2020 (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.
β-thalassemia disease is one of the most common congenital hemolytic anemia commonly found in the malarial belt areas including the Mediterranean, the Middle East, Africa, Southeast Asian countries, and China.
Detailed description
β-thalassemia represents a major public health problem in Egypt, it is estimated that there are 1000/1.5 million per year live births born with β-thalassemia. The average life expectancy of patients with β-thalassemia has improved over the last few years as compared to that of in the previous millennium. This has led to the discovery of new set of problems such as increased hypercoagulable state in β-thalassemia like micro infarcts in spleen and lung indicating an activated coagulation pathway. The, incidence of thromboembolism in patients with thalassemia disease is approximately 10 times higher than normal population, it accounts between 1.7 and 9.2%. On the other hand, a study conducted by Chaudhary and Ahmad, 2012 showed decreased aggregation in majority of β-thalassemia patients. Another study conducted by Ibrahim, 1999 had noticed few patients to have bleeding manifestations in the form of epistaxis. Mussumeci et al., 1987 noted that both thrombophilic and anti-thrombophilic proteins were reduced as a consequence of liver damage. The net clinical outcome depends on the fine balance between the prothrombotic and antithrombotic pathways.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | – | Diagnostic Test: PT, Diagnostic Test: Protein C, Diagnostic Test: Platelet aggregation by ADP and arachidonic acidDiagnosed beta-thalassemia patients at Assiut University Hospital. |
Who may qualify
- Ages
- 4 to 20 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Diagnosed beta-thalassemia patients attending Pediatric Hematology Outpatient Clinic at Assiut University Hospital.
Key inclusion criteria (2 listed)
- All blood samples from thalassemia patients before blood transfusion.
- In splenectomized patients taking Aspirin, the tests will be performed 7 days after discontinuation of the drug.
Key exclusion criteria (3 listed)
- Patients with other hemoglobinopathies other than beta-thalassemia.
- Patients suffering from hepatic or cardiac dysfunctions of another aetiology.
- Patients with history of familial thrombophilia or use of anticoagulant therapy.
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 |
|---|---|---|
| PTmeasuring PT drawn on citrated blood sample | Diagnostic test | study group |
| Protein Cmeasuring protein C drawn on citrated blood sample | Diagnostic test | study group |
| Platelet aggregation by ADP and arachidonic acidmeasuring platelet aggregation drawn on citrated blood sample | Diagnostic test | study group |
Primary outcome
Hypercoagulability versus platelet dysfunction
Time frame: one year
Predominance of hypercoagulability versus platelet dysfunction in beta-thalassemia patients
1 secondary outcome
Regular screening of thalassemia patients
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Background: PubMed 26664743Winichakoon P, Tantiworawit A, Rattanathammethee T, Hantrakool S, Chai-Adisaksopha C, Rattarittamrong E, Norasetthada L, Charoenkwan P. Prevalence and Risk Factors for Complications in Patients with Nontransfusion Dependent Alpha- and Beta-Thalassemia. Anemia. 2015;2015:793025. doi: 10.1155/2015/793025. Epub 2015 Nov 18.
- Background: PubMed 20712798Cappellini MD, Motta I, Musallam KM, Taher AT. Redefining thalassemia as a hypercoagulable state. Ann N Y Acad Sci. 2010 Aug;1202:231-6. doi: 10.1111/j.1749-6632.2010.05548.x.
- Individual participant dataSharing planned: Undecided
Related trials for Beta-Thalassemia
RecruitingObservational study
Growth and Development-related Outcomes in Children With Transfusion-dependent Beta-thalassemia After Gene Therapy
Transfusion-dependent Beta-Thalassemia, Gene Therapy
Active, not recruiting
Evaluation the Safety and Efficacy of KL003 Cell Injection in the Treatment of Transfusion-dependent β-thalassemia.
Transfusion-dependent Beta-Thalassemia
RecruitingPhase 1/2
β-Thalassemia Treatment With KL003 Cell Injection
Transfusion-dependent Beta-Thalassemia
Not yet recruiting
Gene Therapy of Beta Thalassemia Using a Self-inactivating Lentiviral Vector
Beta-Thalassemia
Active, not recruitingPhase 3
A Study Evaluating the Efficacy and Safety of Mitapivat in Participants With Non-Transfusion-Dependent Alpha- or Beta-Thalassemia (α- or β-NTDT)
Non-Transfusion-dependent Alpha-Thalassemia, Non-Transfusion-dependent Beta-Thalassemia
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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Beta-Thalassemia, 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 7 May 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hanan G Abd El-Azeem, Professor (01227370520 ext. 002, hanangalal2000@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypercoagulability versus platelet dysfunction (time frame: one year). 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 NCT04219449, which also lists 2 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 7 May 2024.