Caring for Those Who Share: Improving the Health of Wisconsin Blood Donors

August 10, 2010 updated by: Medical College of Wisconsin
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.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53201
        • BloodCenter of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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%

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
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.
Active Comparator: 2
standard approach currently being used
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
self-reported seeking of medical care for diagnosis of anemia found at time of blood donation
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Kenneth G Schellhase, MD MPH, Medical College of Wisconsin
  • Principal Investigator: Alan Mast, MD PHD, Versiti

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

October 13, 2008

First Submitted That Met QC Criteria

October 14, 2008

First Posted (Estimate)

October 15, 2008

Study Record Updates

Last Update Posted (Estimate)

August 11, 2010

Last Update Submitted That Met QC Criteria

August 10, 2010

Last Verified

August 1, 2010

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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