Blood Transfusions in Thalassemia Patients, Complications and Adverse Effects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr Koren Ariel, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT00971880
First received: September 3, 2009
Last updated: August 25, 2011
Last verified: August 2011

September 3, 2009
August 25, 2011
May 2009
November 2010   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00971880 on ClinicalTrials.gov Archive Site
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Blood Transfusions in Thalassemia Patients, Complications and Adverse Effects
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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Retrospective
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Probability Sample

Patients receiving blood transfusions due to chronic hematologic disorders

  • Thalassemia
  • Sickle Cell Anemia
Other: Clinical medical record summary
Summary of immediate and late adverse effects of blood transfusions
Patients receiving blood transfusions
All the patients with blood disorders that require blood transfusions
Intervention: Other: Clinical medical record summary
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
November 2010
November 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients receiving blood transfusions due to chronic hematologic disorders

Exclusion Criteria:

  • Not applicable
Both
1 Month to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00971880
0039-09-EMC
No
Dr Koren Ariel, HaEmek Medical Center, Israel
HaEmek Medical Center, Israel
Not Provided
Not Provided
HaEmek Medical Center, Israel
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP