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NCT00971880 Clinical Trial

Blood Transfusions in Thalassemia Patients, Complications and Adverse Effects

Sickle Cell Anemia Clinical Trial

Official title:
Blood Transfusions in Thalassemia Patients, Complications and Adverse Effects.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00971880
Other study ID # 0039-09-EMC
Secondary ID
Status Completed
Phase N/A
First received September 3, 2009
Last updated August 25, 2011
Start date May 2009
Est. completion date November 2010

Study information
Verified date August 2011
Source HaEmek Medical Center, Israel
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date November 2010
Est. primary completion date November 2010
Accepts healthy volunteers No
Gender Both
Age group 1 Month to 50 Years
Eligibility Inclusion Criteria:

- Patients receiving blood transfusions due to chronic hematologic disorders

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Other:
• Clinical medical record summary
Summary of immediate and late adverse effects of blood transfusions

Locations
Country Name City State
Israel Pediatric Hematology Unit and Pediatric Dpt B - HaEmek Medical Center Afula

Sponsors (1)
Lead Sponsor Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

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