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

NCT00302900 | Completed Phase 2 DMC

• 2 other identifiers: 371R01HL077438
• Study Type: interventional
• Target: 441
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Syncope, Vasovagal

Keywords

Blood Donation; Syncope; Vasovagal Reactions

Outcome Measures

Primary Outcomes (3)

• Participant ratings of negative (vasovagal) reactions

  Measured within 30 minutes of donating

• Phlebotomist ratings of donor reactions

  Measured immediately following donation

• Number of repeat donations

  Measured 2 years post-donation

Secondary Outcomes (2)

• Subjective ratings of muscle soreness and fatigue

  Measured 24 hours post-donation

• Negative (vasovagal) reactions

  Measured 24 hours post-donation

Study Arms (4)

1

EXPERIMENTAL

Pre-donation water and muscle tension during donation

Behavioral: Pre-Donation Water Consumption; Behavioral: Muscle Tensing Exercise During Donation

2

EXPERIMENTAL

Pre-donation water

Behavioral: Pre-Donation Water Consumption

3

SHAM COMPARATOR

Pre-donation muscle tension

Behavioral: Muscle Tensing Exercise Prior to Donation

4

NO INTERVENTION

Standard donation

Interventions

Pre-Donation Water Consumption BEHAVIORAL

Consumption of 500 ml of bottled water 30 minutes prior to donating

1; 2

Muscle Tensing Exercise During Donation BEHAVIORAL

Alternating leg lifts at 10-second intervals during donation

1

Muscle Tensing Exercise Prior to Donation BEHAVIORAL

Alternating leg lifts at 10-second intervals prior to insertion of the donation needle

3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must meet American Red Cross donor eligibility requirements

You may not qualify if:

• No more than two prior blood donations

Sponsors & Collaborators

• Ohio University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

Ohio University

Athens, Ohio, 45701, United States

Location

American Red Cross Blood Services - Central Ohio Region

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Conditions

Syncope, Vasovagal; Syncope

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Christopher R. France, PhD

  Ohio University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2006
• First Posted: March 15, 2006
• Study Start: January 1, 2006
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: October 6, 2016

Record last verified: 2009-02

Data Sharing

• IPD Sharing: Will share

Locations

US (2)