Red Blood Cell Transfusion in the Ambulatory Setting: Impact on Home Functional Status

February 12, 2019 updated by: Daryl J. Kor, M.D., Mayo Clinic
Do ambulatory RBC transfusions improve home functional status?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: Red blood cell (RBC) transfusion is frequently employed in both ambulatory and hospital environments with the aim of improving patient functional status. The efficacy of this 10.5 billion dollar per year practice however has been increasingly called into question. The Investigators propose to directly measure the impact of outpatient RBC transfusions on at-home functional status by recording several physiological parameters and quantifiable physical activity metrics, e.g. daily energy expenditure and daily total step count, using the ActiGraph wGT3X-BT. This device is an accelerometer-based wearable similar in size to a small watch and is worn at the waist. Study participants will wear the device during the course of their daily activities giving the investigators quantifiable insight into activity levels in the home environment.

Methods/Design: This will be a randomized crossover pilot clinical trial with participant study duration of 28 days. The crossover nature allows each patient to serve as his/her own control. Details of the study design are provided in the text. Briefly, patients presenting at Mayo Clinic Scottsdale's Ambulatory Infusion Center (AIC) will be randomized to one of two arms: 1) receive an RBC transfusion as scheduled (transfuse), or 2) abstain from the scheduled transfusion (no-transfuse). After an appropriate washout period, patients will cross from the transfuse arm to the no-transfuse arm or vice-versa. Activity levels will be recorded continuously throughout the study with no need for intervention by the patient. In addition to device data, survey data will be collected via a weekly telephone interview. The primary outcome measures will include both technical performance metrics such as daily energy expenditure as well as practical performance metrics such as changes in step count. A variety of secondary outcome measures include daily sedentary time and PROMIS Global 10 scores.

Discussion: This trial will directly assess the impact of red blood cell transfusion on patient functional status in the location most important - the home. Patient recruitment will begin in August 2016 and is due to be completed in August 2017.

Study Type

Interventional

Enrollment (Actual)

20

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

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic in Arizona

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:

  • Age > 18 years
  • At least on prior encounter in the AIC
  • Planned RBC transfusion

Exclusion Criteria:

  • Refusal to provide informed consent
  • Refusal by the health care team
  • Acute ischemia (e.g. MI, CVA)
  • Hemoglobin < 7.0 g/dL
  • Active bleeding
  • Symptomatic anemia (hypotension, tachycardia, angina, syncope/pre-syncope believed related to anemia
  • Non-ambulatory functional status
  • Established or Uncertain Pregnancy Status

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Transfuse
Patients will receive a transfusion under standard care
Experimental: No-Transfuse
Patients will not receive a transfusion
Other: No-Transfuse
Patients will not receive an otherwise-indicated red blood cell transfusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent Change in Average Daily Physical Activity
Time Frame: Baseline to 7 Days
Baseline to 7 Days

Collaborators and Investigators

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

Sponsor

Mayo Clinic

Collaborators

Arizona State University

Investigators

  • Principal Investigator: Daryl J Kor, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

September 1, 2016

Primary Completion (Actual)

November 10, 2017

Study Completion (Actual)

November 10, 2017

Study Registration Dates

First Submitted

July 14, 2016

First Submitted That Met QC Criteria

July 15, 2016

First Posted (Estimate)

July 18, 2016

Study Record Updates

Last Update Posted (Actual)

February 15, 2019

Last Update Submitted That Met QC Criteria

February 12, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-006487

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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