Overview

This trial is active, not recruiting.

Condition syncope, vasovagal
Treatments pre-donation water consumption, muscle tensing exercise during donation, muscle tensing exercise prior to donation
Phase phase 2
Sponsor National Heart, Lung, and Blood Institute (NHLBI)
Start date January 2006
End date March 2010
Trial size 400 participants
Trial identifier NCT00302900, 371, R01 HL077438-01A2

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Pre-donation water and muscle tension during donation
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
(Experimental)
Pre-donation water
pre-donation water consumption
Consumption of 500 ml of bottled water 30 minutes prior to donating
(Sham Comparator)
Pre-donation muscle tension
muscle tensing exercise prior to donation
Alternating leg lifts at 10-second intervals prior to insertion of the donation needle
(No Intervention)
Standard donation

Primary Outcomes

Measure
Participant ratings of negative (vasovagal) reactions
time frame: Measured within 30 minutes of donating
Phlebotomist ratings of donor reactions
time frame: Measured immediately following donation
Number of repeat donations
time frame: Measured 2 years post-donation

Secondary Outcomes

Measure
Subjective ratings of muscle soreness and fatigue
time frame: Measured 24 hours post-donation
Negative (vasovagal) reactions
time frame: Measured 24 hours post-donation

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Must meet American Red Cross donor eligibility requirements Exclusion Criteria: - No more than two prior blood donations

Additional Information

Official title Preventing Adverse Reactions in Novice Blood Donors
Principal investigator Christopher R. France, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2009.
Information provided to ClinicalTrials.gov by National Heart, Lung, and Blood Institute (NHLBI).