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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
History of Changes
  Purpose

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 Intervention
Thalassemia
Sickle Cell Anemia
 Other: Clinical medical record summary

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Blood Transfusions in Thalassemia Patients, Complications and Adverse Effects.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by HaEmek Medical Center, Israel:

Estimated Enrollment: 100
Study Start Date: May 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   1 Month to 50 Years
Genders Eligible for Study:   Both
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:

  • Not applicable
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: September 3, 2009
Last Updated: August 25, 2011
Health Authority: Israel: Ministry of Health

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

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

ClinicalTrials.gov processed this record on June 18, 2013