Beta Thalassemia Major AnemiaTG-THALNCT04962984
Thrombin Generation in Beta-thalassemia Major
A study testing blood sampling in people with Beta Thalassemia Major Anemia, run by Central Hospital, Nancy, France.
Trial summary
This study aims to evaluate the persistence of a hypercoagulable state in chronically-transfused patients with beta thalassemia major, by using the thrombin generation test (performed in whole blood and plasma). Read more about this study
- Who is it for?
- Ages 10 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Beta Thalassemia Major Anemia
- What is being tested?
- blood sampling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2021to 1 Sep 2024
- Phase
- Interventional
- 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 10 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patient with de Beta-thalassemia major
- Patient with regular blood transfusion regimen (every 4 - 6 weeks)
- informed and signed consent
- weight > 30kg
- Hemoglobin > 7g/dL
Who cannot join
- Emergency situation
- Patients receiving antithrombotic drugs (anticoagulants such as Vitamin K antagonism, heparin or direct oral anticoagulant) or antiplatelet drugs;
- women of childbearing age without contraception
- pregnancy
- deprivation of liberty
- no consent
About this study
Official title: Evaluation of Hypercoagulability by Thrombin Generation Test in Beta-thalassemia Major
This study aims to evaluate the persistence of a hypercoagulable state in chronically-transfused patients with beta thalassemia major, by using the thrombin generation test (performed in whole blood and plasma). Patients will be compared with 2 control groups: 1/ healthy volunteers and 2/ carriers of beta-thalassemia trait
- Conditions
- Beta Thalassemia Major Anemia
- Being tested
- blood sampling
- Keywords
- Beta Thalassemia Major; hypercoagulability; thrombin generation test
- Medical subject headings
- beta-Thalassemia, Thrombophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingProcedure or surgery
additional blood sampling for coagulation tests
| Study group | Role | What they receive |
|---|---|---|
| THAL + | Experimental | patients with beta thalassemia major, requiring blood transfusion regimen. Additional blood sampling will be performed before and immediately after transfusion (21 millilters and 24 millilters respectively), on the occasion of 3 programed transfusions (consecutive or not). Receives: Procedure: blood sampling |
| THAL - | Sham comparator | Patients with beta thalassemia trait, matched with THAL + for age and gender. An unique blood sampling of 24 millilters will be performed. Receives: Procedure: blood sampling |
| Healthy volunteers | Sham comparator | healthy subjects, matched with THAL + for age and gender. An unique blood sampling of 24 millilters will be performed. Receives: Procedure: blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of hypercoagulability using endogenous thrombin potential (ETP) between patients and controls
Measurement of the area under the thrombin generation curve (ie ETP) in THAL+ patients, before and after transfusion, as compared with ETP measured in controls groups (THAL- and healthy volunteers)
Measured: 6 months
Secondary outcomes (1)
Evaluation of endogenous thrombin potential's variations before and after transfusion in THAL+ patients over 3 transfusion episodes
Measurement of the area under the thrombin generation curve before and after transfusion in THAL+ patients over 3 transfusion episodes
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start1 Sep 2021 (estimated)
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Beta Thalassemia Major AnemiaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04962984
- Sponsor's protocol ID
- CPRC 2017/TG THAL-MARTIN/MS
- Acronym
- TG-THAL
- Status last verified
- Jun 2021
- First submitted
- 24 Sep 2018
- Last updated
- 15 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Hypercoagulability by Thrombin Generation Test in Beta-thalassemia Major
- ClinicalTrials.gov ID
- NCT04962984
- Acronym / sponsor ID
- TG-THAL / CPRC 2017/TG THAL-MARTIN/MS
- Conditions
- Beta Thalassemia Major Anemia
- Keywords
- Beta Thalassemia Major; hypercoagulability; thrombin generation test
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 15 Jul 2021 (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.
This study aims to evaluate the persistence of a hypercoagulable state in chronically-transfused patients with beta thalassemia major, by using the thrombin generation test (performed in whole blood and plasma). Patients will be compared with 2 control groups: 1/ healthy volunteers and 2/ carriers of beta-thalassemia trait
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| THAL + | Experimental | Procedure: blood samplingpatients with beta thalassemia major, requiring blood transfusion regimen. Additional blood sampling will be performed before and immediately after transfusion (21 millilters and 24 millilters respectively), on the occasion of 3 programed transfusions (consecutive or not). |
| THAL - | Sham comparator | Procedure: blood samplingPatients with beta thalassemia trait, matched with THAL + for age and gender. An unique blood sampling of 24 millilters will be performed. |
| Healthy volunteers | Sham comparator | Procedure: blood samplinghealthy subjects, matched with THAL + for age and gender. An unique blood sampling of 24 millilters will be performed. |
Who may qualify
- Ages
- 10 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patient with de Beta-thalassemia major
- Patient with regular blood transfusion regimen (every 4 - 6 weeks)
- informed and signed consent
- weight > 30kg
- Hemoglobin > 7g/dL
Key exclusion criteria (6 listed)
- Emergency situation
- Patients receiving antithrombotic drugs (anticoagulants such as Vitamin K antagonism, heparin or direct oral anticoagulant) or antiplatelet drugs;
- women of childbearing age without contraception
- pregnancy
- deprivation of liberty
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 |
|---|---|---|
| blood samplingadditional blood sampling for coagulation tests | Procedure or surgery | Healthy volunteers, THAL +, THAL - |
Primary outcome
Evaluation of hypercoagulability using endogenous thrombin potential (ETP) between patients and controls
Time frame: 6 months
Measurement of the area under the thrombin generation curve (ie ETP) in THAL+ patients, before and after transfusion, as compared with ETP measured in controls groups (THAL- and healthy volunteers)
1 secondary outcome
Evaluation of endogenous thrombin potential's variations before and after transfusion in THAL+ patients over 3 transfusion episodes
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2021.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing blood sampling in people with Beta Thalassemia Major Anemia, run by Central Hospital, Nancy, France.
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 5 inclusion and 6 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 15 Jul 2021. 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of hypercoagulability using endogenous thrombin potential (ETP) between patients and controls (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jul 2021.