NCT02835937

Brief Summary

Do ambulatory RBC transfusions improve home functional status?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 18, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2017

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

1.2 years

First QC Date

July 14, 2016

Last Update Submit

February 12, 2019

Conditions

Red Blood Cell TransfusionsAnemiaHematologyOncologyAmbulatory Care

Outcome Measures

Primary Outcomes (1)

  • Percent Change in Average Daily Physical Activity

    Baseline to 7 Days

Study Arms (2)

Transfuse

NO INTERVENTION

Patients will receive a transfusion under standard care

No-Transfuse

EXPERIMENTAL

Patients will not receive a transfusion

Other: No-Transfuse

Interventions

No-TransfuseOTHER

Patients will not receive an otherwise-indicated red blood cell transfusion

No-Transfuse

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Related Publications (1)

  • Murphree DH, Kinard TN, Khera N, Storlie CB, Ngufor C, Upadhyaya S, Pathak J, Fortune E, Jacob EK, Carter RE, Poterack KA, Kor DJ. Measuring the impact of ambulatory red blood cell transfusion on home functional status: study protocol for a pilot randomized controlled trial. Trials. 2017 Mar 31;18(1):153. doi: 10.1186/s13063-017-1873-z.

    PMID: 28359342DERIVED

MeSH Terms

Conditions

AnemiaNeoplasms

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Daryl J Kor

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prinicipal Investigator

Study Record Dates

First Submitted

July 14, 2016

First Posted

July 18, 2016

Study Start

September 1, 2016

Primary Completion

November 10, 2017

Study Completion

November 10, 2017

Last Updated

February 15, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)