Preventing Negative Reactions in First Time Blood Donors to Encourage Subsequent Blood Donations

Syncope, Vasovagal Clinical Trial

Official title:

Preventing Adverse Reactions in Novice Blood Donors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00302900
• Other study ID #: 371
• Secondary ID: R01HL077438
• Status: Completed
• Phase: Phase 2
• First received: March 14, 2006
• Last updated: October 4, 2016
• Start date: January 2006
• Est. completion date: March 2010

Study information

• Verified date: February 2009
• Source: Ohio University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

Many individuals experience negative reactions when donating blood, including dizziness, lightheadedness, or fainting. Such reactions may discourage them from donating again. This study will evaluate the effectiveness of pre-donation water consumption and a muscle tensing exercise during donation to reduce negative reactions among new blood donors. This study will also evaluate whether reducing negative reactions increases the likelihood of donors returning to give blood in the future.

Description:

Severe and potentially dangerous shortages in the blood supply are increasingly common in the United States. As the population ages and as more stringent donor eligibility restrictions are enforced, blood shortages are expected to worsen. One way to meet the increasing demand for blood is to recruit new blood donors. Ideally, these individuals would become lifelong donors, and contribute up to six times per year and up to hundreds of units of blood within a lifetime. Unfortunately, less than half of all new donors provide a second donation. Many individuals who donate blood experience dizziness, weakness, lightheadedness, or in severe cases, fainting. As a result of these negative reactions, many individuals never donate blood again. Preventing these reactions may be an effective way to encourage subsequent blood donations. The purpose of this study is to evaluate the effectiveness of consuming water prior to donation and performing a muscle tensing exercise during donation as ways to reduce negative reactions in new blood donors. The study's long-term goal is to provide blood collection agencies with simple and inexpensive strategies to prevent negative reactions and enhance donor retention.

This study will enroll American Red Cross blood donors who have donated blood no more than twice previously. Participants will be randomly assigned to one of the following four groups: 1) pre-donation water consumption and muscle tensing exercise during donation; 2) pre-donation water consumption; 3) pre-donation muscle tensing exercise; or 4) no treatment. Participant reactions will be assessed at the time of donation by self-report and phlebotomist ratings, as well as by self-report 24 hours following the donation. Participants' subsequent donation history will be tracked for two years by reviewing the American Red Cross national donor database.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 441
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Must meet American Red Cross donor eligibility requirements

Exclusion Criteria:

• No more than two prior blood donations

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Syncope
• Syncope, Vasovagal

Intervention

Behavioral:
• Pre-Donation Water Consumption
Consumption of 500 ml of bottled water 30 minutes prior to donating
• Muscle Tensing Exercise During Donation
Alternating leg lifts at 10-second intervals during donation
• Muscle Tensing Exercise Prior to Donation
Alternating leg lifts at 10-second intervals prior to insertion of the donation needle

Locations

Country	Name	City	State
United States	Ohio University	Athens	Ohio
United States	American Red Cross Blood Services - Central Ohio Region	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant ratings of negative (vasovagal) reactions		Measured within 30 minutes of donating	No
Primary	Phlebotomist ratings of donor reactions		Measured immediately following donation	Yes
Primary	Number of repeat donations		Measured 2 years post-donation	No
Secondary	Subjective ratings of muscle soreness and fatigue		Measured 24 hours post-donation	No
Secondary	Negative (vasovagal) reactions		Measured 24 hours post-donation	No