NCT00772083

Brief Summary

Blood donors are a precious community resource. Each month at Blood Center of Wisconsin (BCW), 200 men and 600 women over age 50 are turned away ("deferred") because of anemia. In those over 50, anemia may signal serious underlying disease such as colorectal cancer (CRC). CRC is the #3 cause of cancer death in Wisconsin with more than 1,000 deaths in 2006. Yet with proper testing CRC outcomes can be improved by early diagnosis. This project will focus on a population of deferred older blood donors to develop and test educational materials that will motivate donors to seek medical attention for their anemia, so that the underlying cause is diagnosed and treated. This project has the potential to lead to better CRC outcomes in Wisconsin blood donors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2008

Shorter than P25 for not_applicable

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

October 13, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 15, 2008

Completed
17 days until next milestone

Study Start

First participant enrolled

November 1, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

August 11, 2010

Status Verified

August 1, 2010

Enrollment Period

7 months

First QC Date

October 13, 2008

Last Update Submit

August 10, 2010

Conditions

Outcome Measures

Primary Outcomes (1)

  • self-reported seeking of medical care for diagnosis of anemia found at time of blood donation

    3 months

Study Arms (2)

1

EXPERIMENTAL
Behavioral: Educational brochure

2

ACTIVE COMPARATOR

standard approach currently being used

Behavioral: Standard pamphlet

Interventions

This brochure will educate anemic blood donors regarding the possible causes of their anemia, and based on age will make recommendations for who should seek consultation with a physician.

1

The BloodCenter of Wisconsin's default action when a potential donor has been found to be anemic is to provide a standard pamphlet with very basic nutritional information.

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult blood donors who have been "deferred" (not allowed to donate) due to low blood count, specifically all male donors found to have hematocrit \< 38% and to all female donors over 50 years old found to have hematocrit \< 36%

You may not qualify if:

  • deferred donors who have previously donated more than 3 times in the past year, as their anemia is more likely due to frequent donation
  • women less than 50 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BloodCenter of Wisconsin

Milwaukee, Wisconsin, 53201, United States

Location

MeSH Terms

Conditions

AnemiaColorectal Neoplasms

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Kenneth G Schellhase, MD MPH

    Medical College of Wisconsin

    PRINCIPAL INVESTIGATOR
  • Alan Mast, MD PHD

    Versiti Blood Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 13, 2008

First Posted

October 15, 2008

Study Start

November 1, 2008

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

August 11, 2010

Record last verified: 2010-08

Locations