NCT00971880

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 4, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

August 26, 2011

Status Verified

August 1, 2011

Enrollment Period

1.5 years

First QC Date

September 3, 2009

Last Update Submit

August 25, 2011

Conditions

ThalassemiaSickle Cell Anemia

Keywords

Blood transfusionsAdverse eventsHepatitis CHIV

Study Arms (1)

Patients receiving blood transfusions

All the patients with blood disorders that require blood transfusions

Other: Clinical medical record summary

Interventions

Clinical medical record summaryOTHER

Summary of immediate and late adverse effects of blood transfusions

Patients receiving blood transfusions

Eligibility Criteria

Age1 Month - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Patients receiving blood transfusions due to chronic hematologic disorders

You may qualify if:

  • Patients receiving blood transfusions due to chronic hematologic disorders

You may not qualify if:

  • Not applicable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric Hematology Unit and Pediatric Dpt B - HaEmek Medical Center

Afula, 18101, Israel

Location

MeSH Terms

Conditions

ThalassemiaAnemia, Sickle CellHepatitis C

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Pediatric Hematology Unit and Pediatric Dpt B

Study Record Dates

First Submitted

September 3, 2009

First Posted

September 4, 2009

Study Start

May 1, 2009

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

August 26, 2011

Record last verified: 2011-08

Locations

IL(1)