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Blood Transfusions in Thalassemia Patients, Complications and Adverse Effects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00971880
Recruitment Status : Completed
First Posted : September 4, 2009
Last Update Posted : August 26, 2011
Sponsor:
Information provided by (Responsible Party):
Dr Koren Ariel, HaEmek Medical Center, Israel

Tracking Information
First Submitted Date September 3, 2009
First Posted Date September 4, 2009
Last Update Posted Date August 26, 2011
Study Start Date May 2009
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Blood Transfusions in Thalassemia Patients, Complications and Adverse Effects
Official Title Blood Transfusions in Thalassemia Patients, Complications and Adverse Effects.
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.

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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients receiving blood transfusions due to chronic hematologic disorders
Condition
  • Thalassemia
  • Sickle Cell Anemia
Intervention Other: Clinical medical record summary
Summary of immediate and late adverse effects of blood transfusions
Study Groups/Cohorts Patients receiving blood transfusions
All the patients with blood disorders that require blood transfusions
Intervention: Other: Clinical medical record summary
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Estimated Enrollment
 (submitted: September¬†3,¬†2009)
100
Original Estimated Enrollment Same as current
Actual Study Completion Date November 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients receiving blood transfusions due to chronic hematologic disorders

Exclusion Criteria:

  • Not applicable
Sex/Gender
Sexes Eligible for Study: All
Ages 1 Month to 50 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT00971880
Other Study ID Numbers 0039-09-EMC
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dr Koren Ariel, HaEmek Medical Center, Israel
Study Sponsor HaEmek Medical Center, Israel
Collaborators Not Provided
Investigators Not Provided
PRS Account HaEmek Medical Center, Israel
Verification Date August 2011