NCT01580267

Brief Summary

Anemia (decreased number of red blood cells) is common in critically ill trauma patients admitted to an Intensive Care Unit and is associated with a high rate of blood transfusions. This "anemia of inflammation" is a result of three mechanisms: impaired iron regulation, shortened red blood cell life span, and reduced rate of erythropoiesis (a protein that helps make new red blood cells). Hepcidin, a protein made in the liver, regulates iron and is decreased when iron in the blood is low. This can lead to anemia. This research study is being conducted to learn how inflammation, hepcidin, and erythropoietin interact in critically ill patients. The findings will help in determining effective treatment for patients with anemia of inflammation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2012

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 18, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

April 28, 2014

Status Verified

April 1, 2014

Enrollment Period

1.8 years

First QC Date

April 17, 2012

Last Update Submit

April 24, 2014

Conditions

Anemia

Keywords

Anemia in trauma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Trauma patients, 18 years of age or older, admitted to a University of Michigan ICU

You may qualify if:

  • Trauma patient
  • Age 18 years or older
  • Admitted to ICU
  • Anemic (Hct \< 34.5%)

You may not qualify if:

  • Pre-existing hematological disorder
  • Pre-existing diagnosis of anemia or other known iron disorder
  • Chronic renal failure
  • Use of recombinant erythropoietin
  • Treatment with systemic immunosuppressant or cytotoxic drugs
  • Pregnancy
  • Patients not expected to survive

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Lena M Napolitano, MD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 17, 2012

First Posted

April 18, 2012

Study Start

June 1, 2012

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

April 28, 2014

Record last verified: 2014-04

Locations

US(1)