ThalassemiaNCT00971880
Blood Transfusions in Thalassemia Patients, Complications and Adverse Effects
An observational study of Thalassemia and Sickle Cell Anemia, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
Patients suffering from Thalassemia or another hemoglobinopathies required regular blood transfusions. The complications and adverse effects of blood transfusions can be classified as immediate and late. Read more about this study
- Who is it for?
- Ages 1 month to 50 years
- Conditions the study is for
- Thalassemia, Sickle Cell Anemia
- What is being tested?
- Clinical medical record summary
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- May 2009to Nov 2010
- 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 1 month to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients receiving blood transfusions due to chronic hematologic disorders
Who may be able to join
- Patients receiving blood transfusions due to chronic hematologic disorders
Who cannot join
- Not applicable
Trial locations and contacts
1 site in 1 country.
Israel1 site
Pediatric Hematology Unit and Pediatric Dpt B - HaEmek Medical Center
Afula, 18101
About this study
Official title: Blood Transfusions in Thalassemia Patients, Complications and Adverse Effects.
Patients suffering from Thalassemia or another hemoglobinopathies required regular blood transfusions. The complications and adverse effects of blood transfusions can be classified as immediate and late. Among the immediate effects the most common are allergic reactions and fever, besides congestive heart failure in patients with cardiomyopathy. The late effects are mostly related to blood transmitted infections like HIV or Hepatitis C infections.
The purpose of this study is to summarize the data of those complications in a cohort of 100 patients receiving regular blood transfusion.
Read the detailed description
About 100 patients aged several months to 50 years are treated in the Pediatric Hematology Unit, most of those patients receive blood transfusions monthly. The adverse reactions were routinely recorded during each transfusion. All the patients were also screened annually for the incidence of blood transmitted infections principally HIV and Hepatitis C. All those records will be systematically screened and all the immediate or late adverse reactions and complications related to blood transfusions will be summarized.
A second goal of this study will be to control the staff strictness related to the ministry of health protocol dealing to blood transfusions.
- Conditions
- Thalassemia, Sickle Cell Anemia
- Being tested
- Clinical medical record summary
- Keywords
- Blood transfusions, Adverse events, Hepatitis C, HIV
- Medical subject headings
- Thalassemia, Anemia, Sickle Cell, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical medical record summaryOther
Summary of immediate and late adverse effects of blood transfusions
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving blood transfusions | All the patients with blood disorders that require blood transfusions Receives: Other: Clinical medical record summary |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2009 (estimated)
- Study startMay 2009
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThalassemiaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Koren Ariel, HaEmek Medical Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00971880
- Sponsor's protocol ID
- 0039-09-EMC
- Status last verified
- Aug 2011
- First submitted
- 3 Sep 2009
- Last updated
- 26 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Transfusions in Thalassemia Patients, Complications and Adverse Effects.
- ClinicalTrials.gov ID
- NCT00971880
- Acronym / sponsor ID
- 0039-09-EMC
- Conditions
- Thalassemia, Sickle Cell Anemia
- Keywords
- Blood transfusions, Adverse events, Hepatitis C, HIV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 4 Sep 2009 (estimated)
- 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.
Patients suffering from Thalassemia or another hemoglobinopathies required regular blood transfusions. The complications and adverse effects of blood transfusions can be classified as immediate and late. Among the immediate effects the most common are allergic reactions and fever, besides congestive heart failure in patients with cardiomyopathy. The late effects are mostly related to blood transmitted infections like HIV or Hepatitis C infections.
The purpose of this study is to summarize the data of those complications in a cohort of 100 patients receiving regular blood transfusion.
Detailed description
About 100 patients aged several months to 50 years are treated in the Pediatric Hematology Unit, most of those patients receive blood transfusions monthly. The adverse reactions were routinely recorded during each transfusion. All the patients were also screened annually for the incidence of blood transmitted infections principally HIV and Hepatitis C. All those records will be systematically screened and all the immediate or late adverse reactions and complications related to blood transfusions will be summarized.
A second goal of this study will be to control the staff strictness related to the ministry of health protocol dealing to blood transfusions.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients receiving blood transfusions | – | Other: Clinical medical record summaryAll the patients with blood disorders that require blood transfusions |
Who may qualify
- Ages
- 1 month to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients receiving blood transfusions due to chronic hematologic disorders
Key inclusion criteria (1 listed)
- Patients receiving blood transfusions due to chronic hematologic disorders
Key exclusion criteria (1 listed)
- Not applicable
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 |
|---|---|---|
| Clinical medical record summarySummary of immediate and late adverse effects of blood transfusions | Other | Patients receiving blood transfusions |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2011.
Related trials for Thalassemia
Active, not recruiting
Evaluation the Safety and Efficacy of KL003 Cell Injection in the Treatment of Transfusion-dependent β-thalassemia.
Transfusion-dependent 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
Not yet recruiting
Gene Therapy of Beta Thalassemia Using a Self-inactivating Lentiviral Vector
Beta-Thalassemia
RecruitingPhase 1/2
β-Thalassemia Treatment With KL003 Cell Injection
Transfusion-dependent 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thalassemia and Sickle Cell Anemia, run by HaEmek Medical Center, Israel at 1 site in Israel.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 26 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 26 Aug 2011.