NCT00029406

Brief Summary

To conduct a prospective study of pediatric transfusion recipients to determine the risk of transmitting various infectious agents by blood transfusion.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2001

Longer than P75 for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2001

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 11, 2002

Completed
11.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

December 16, 2015

Status Verified

December 1, 2015

Enrollment Period

12 years

First QC Date

January 10, 2002

Last Update Submit

December 15, 2015

Conditions

Blood DonorsBlood TransfusionCytomegalovirus InfectionsHepatitis, Viral, HumanHIV Infections

Outcome Measures

Primary Outcomes (1)

  • Rates of transfusion-transmitted viruses

    6 months post-transfusion

Secondary Outcomes (1)

  • Prevalence of newly emerging transfusion-transmitted viruses in blood donors

    6 months post-transfusion

Eligibility Criteria

Age6 Months - 21 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pediatric recipients of allogeneic blood transfusion and linked blood donors

You may qualify if:

  • Pediatric cardiac, orthopedic, and neurosurgery patients
  • Trauma patients who are transfused
  • Sickle cell patients who are sporadically transfused
  • No allogeneic transfusion in the 6 weeks preceding the index transfusion
  • A pre-transfusion sample is available from the recipient
  • Life expectancy greater than 6 months
  • Residence in the continental US

You may not qualify if:

  • History of allogeneic blood transfusion in the prior three months
  • Currently pregnant
  • Patients on dialysis
  • Patients with conditions causing significant immunosuppression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Wong EC, Perez-Albuerne E, Moscow JA, Luban NL. Transfusion management strategies: a survey of practicing pediatric hematology/oncology specialists. Pediatr Blood Cancer. 2005 Feb;44(2):119-27. doi: 10.1002/pbc.20159.

    PMID: 15452914BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood and plasma samples

MeSH Terms

Conditions

Cytomegalovirus InfectionsHepatitis, Viral, HumanHIV Infections

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsHepatitisLiver DiseasesDigestive System DiseasesBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Naomi Luban

    Children's National Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 10, 2002

First Posted

January 11, 2002

Study Start

April 1, 2001

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

December 16, 2015

Record last verified: 2015-12