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Blood Transfusions in Thalassemia Patients, Complications and Adverse Effects

Sponsor
HaEmek Medical Center, Israel (Other)
Overall Status
Completed
CT.gov ID
NCT00971880
Collaborator
(none)
100
Enrollment
1
Location
18
Duration (Months)
5.5
Patients Per Site Per Month

Study Details

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 Phase
  • 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
Anticipated 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 1, 2009
Actual Primary Completion Date :
Nov 1, 2010
Actual Study Completion Date :
Nov 1, 2010

Arms and Interventions

Arm 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

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Month to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients receiving blood transfusions due to chronic hematologic disorders
    Exclusion Criteria:
    • Not applicable

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pediatric Hematology Unit and Pediatric Dpt B - HaEmek Medical Center Afula Israel 18101

    Sponsors and Collaborators

    • HaEmek Medical Center, Israel

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr Koren Ariel, Head of Pediatric Hematology Unit and Pediatric Dpt B, HaEmek Medical Center, Israel
    ClinicalTrials.gov Identifier:
    NCT00971880
    Other Study ID Numbers:
    • 0039-09-EMC
    First Posted:
    Sep 4, 2009
    Last Update Posted:
    Aug 26, 2011
    Last Verified:
    Aug 1, 2011
    Keywords provided by Dr Koren Ariel, Head of Pediatric Hematology Unit and Pediatric Dpt B, HaEmek Medical Center, Israel
    Blood transfusions
    Adverse events
    Hepatitis C
    HIV
    Additional relevant MeSH terms:
    Thalassemia
    Anemia, Sickle Cell

    Study Results

    No Results Posted as of Aug 26, 2011