- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00772083
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
Status
Completed
Conditions
Intervention / Treatment
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.
Sponsor
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
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRO00008944
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.
Clinical Trials on Anemia
-
SanofiActive, not recruitingWarm Autoimmune Hemolytic Anemia (wAIHA)United States, Austria, China, Denmark, Germany, Hungary, Italy, Spain, United Kingdom
-
SanofiTerminatedWarm Autoimmune Hemolytic Anemia (wAIHA)United Kingdom, Belgium, Netherlands, France, United States, Germany, Hungary, Italy
-
Hospital Universitario Dr. Jose E. GonzalezCompletedPernicious Anemia | Megaloblastic Anemia NosMexico
-
Assistance Publique - Hôpitaux de ParisNot yet recruitingSevere Aplastic Anemia | Idiopathic Aplastic Anemia | Moderate Aplastic Anemia Requiring Transfusions
-
Abdelwahed, Mai Mahmoud Mohamed, M.D.UnknownAnemia During PregnancyEgypt
-
University of California, DavisInstituto Mexicano del Seguro Social; Thrasher Research Fund; Mexican National... and other collaboratorsCompleted
-
Incyte CorporationActive, not recruitingWarm Autoimmune Hemolytic Anemia (wAIHA)Spain, United States, Austria, Belgium, Canada, France, Germany, Israel, Italy, Japan, Netherlands, Poland, United Kingdom
-
Peking Union Medical College HospitalRecruiting
-
Alexion PharmaceuticalsWithdrawnWarm Autoimmune Hemolytic AnemiaUnited States
Clinical Trials on Educational brochure
-
Milton S. Hershey Medical CenterCompletedChemotherapy Effect | Chemotherapeutic Toxicity | Chemotherapeutic Agent ToxicityUnited States
-
University Health Network, TorontoEnrolling by invitationParkinson Disease | Dementia | Alzheimer Disease | Vascular Dementia | Frontotemporal Lobar Degeneration | Neuro-Degenerative Disease | Caregiver BurnoutCanada
-
Western Kentucky UniversityRecruitingPregnancy Related | PostpartumUnited States
-
University of Colorado, DenverThe Henry J. Kaiser Family FoundationCompletedColonoscopy | Mass ScreeningUnited States
-
Ann & Robert H Lurie Children's Hospital of ChicagoPatient-Centered Outcomes Research InstituteCompleted
-
Mayo ClinicRecruitingPatient Education in Radiation OncologyUnited States
-
Mayo ClinicMountain Park Health CenterActive, not recruiting
-
University of British ColumbiaTerminated
-
Western Kentucky UniversityUniversity of KentuckyCompletedPregnancy | PostpartumUnited States
-
Massachusetts General HospitalCompletedMindfulness | Orthopaedic InjuryUnited States