NCT00211055

Brief Summary

The purpose of this study is to determine the incidence of anemia and blood transfusions and management of these in critically ill children

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,201

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2004

Shorter than P25 for all trials

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

September 1, 2004

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
Last Updated

April 16, 2013

Status Verified

April 1, 2013

First QC Date

September 13, 2005

Last Update Submit

April 15, 2013

Conditions

Anemia

Keywords

Critically IllIntensive Care UnitBlood transfusionBlood lossPediatricChildrenAnemia, Pediatric Intensive Care UnitHemoglobinTransfusion

Eligibility Criteria

AgeUp to 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Male or female patients aged 0 to 17 years
  • During part 1 of this study, patients must be newly admitted to the Pediatric Intensive Care Unit (PICU) (regardless of stay)
  • During part 2 of the study, patients must be newly admitted to the PICU and have stayed there for \> = 48 hours
  • Patients' legally acceptable representatives must have signed an informed consent
  • Patients aged 7 years and above must give assent if or when they are physically capable

You may not qualify if:

  • Premature infants (patients who were born at \< = 37 weeks who are \< 28 days old)
  • Patients who have previously participated in this study
  • Patients from a family unwilling to receive blood transfusions (for example for religious reasons)
  • Patients who are participating in any other transfusion or blood-related research at the time of entry into the study or any time during the study
  • Patients who are known to be pregnant (no pregnancy test will be performed in this study)
  • Patients with known or suspected brain death
  • Patients who have had a Pediatric Intensive Care Unit (PICU) stay of longer than 72 hours within the 7 days prior to entering the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

AnemiaCritical IllnessHemorrhage

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

September 1, 2004

Study Completion

March 1, 2005

Last Updated

April 16, 2013

Record last verified: 2013-04