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Blood Transfusions in Thalassemia Patients, Complications and Adverse Effects

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ClinicalTrials.gov Identifier: NCT00971880
Recruitment Status : Completed
First Posted : September 4, 2009
Last Update Posted : August 26, 2011
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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. 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.


Condition or disease Intervention/treatment
Thalassemia Sickle Cell Anemia Other: Clinical medical record summary

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

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Blood Transfusions in Thalassemia Patients, Complications and Adverse Effects.
Study Start Date : May 2009
Primary Completion Date : November 2010
Study Completion Date : November 2010


Groups and Cohorts

Group/Cohort Intervention/treatment
Patients receiving blood transfusions
All the patients with blood disorders that require blood transfusions
Other: Clinical medical record summary
Summary of immediate and late adverse effects of blood transfusions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients receiving blood transfusions due to chronic hematologic disorders
Criteria

Inclusion Criteria:

  • Patients receiving blood transfusions due to chronic hematologic disorders

Exclusion Criteria:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00971880


Locations
Israel
Pediatric Hematology Unit and Pediatric Dpt B - HaEmek Medical Center
Afula, Israel, 18101
Sponsors and Collaborators
HaEmek Medical Center, Israel
More Information

Responsible Party: Dr Koren Ariel, Head of Pediatric Hematology Unit and Pediatric Dpt B, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT00971880     History of Changes
Other Study ID Numbers: 0039-09-EMC
First Posted: September 4, 2009    Key Record Dates
Last Update Posted: August 26, 2011
Last Verified: August 2011

Keywords provided by Dr Koren Ariel, HaEmek Medical Center, Israel:
Blood transfusions
Adverse events
Hepatitis C
HIV

Additional relevant MeSH terms:
Thalassemia
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn