Blood Transfusions in Thalassemia Patients, Complications and Adverse Effects

NCT ID: NCT00971880

Last Updated: 2011-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-05-31

Study Completion Date

2010-11-30

Brief Summary

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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

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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

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Thalassemia Sickle Cell Anemia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients receiving blood transfusions

All the patients with blood disorders that require blood transfusions

Clinical medical record summary

Intervention Type OTHER

Summary of immediate and late adverse effects of blood transfusions

Interventions

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Clinical medical record summary

Summary of immediate and late adverse effects of blood transfusions

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients receiving blood transfusions due to chronic hematologic disorders

Exclusion Criteria

* Not applicable
Minimum Eligible Age

1 Month

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HaEmek Medical Center, Israel

OTHER

Sponsor Role lead

Responsible Party

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Dr Koren Ariel

Head of Pediatric Hematology Unit and Pediatric Dpt B

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Pediatric Hematology Unit and Pediatric Dpt B - HaEmek Medical Center

Afula, , Israel

Site Status

Countries

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Israel

Other Identifiers

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0039-09-EMC

Identifier Type: -

Identifier Source: org_study_id

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