Red Blood Cell TransfusionsNCT02835937
Red Blood Cell Transfusion in the Ambulatory Setting: Impact on Home Functional Status
A study testing No-Transfuse in people with Red Blood Cell Transfusions and Anemia, run by Mayo Clinic at 1 site in United States.
Trial summary
Do ambulatory RBC transfusions improve home functional status? Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Red Blood Cell Transfusions, Anemia, Hematology
- What is being tested?
- No-Transfuse
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2016to 10 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- At least on prior encounter in the AIC
- Planned RBC transfusion
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Do ambulatory RBC transfusions improve home functional status?
Read the 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.
- Conditions
- Red Blood Cell Transfusions, Anemia, Hematology, Oncology, Ambulatory Care
- Being tested
- No-Transfuse
- Medical subject headings
- Anemia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No-TransfuseOther
Patients will not receive an otherwise-indicated red blood cell transfusion
| Study group | Role | What they receive |
|---|---|---|
| Transfuse | No intervention | Patients will receive a transfusion under standard care |
| No-Transfuse | Experimental | Patients will not receive a transfusion Receives: Other: No-Transfuse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Average Daily Physical Activity
Measured: Baseline to 7 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2016 (estimated)
- Study start1 Sep 2016
- Primary completion10 Nov 2017
- Study completion10 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Red Blood Cell TransfusionsStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Arizona State University
- Responsible party
- Principal investigator, Daryl J. Kor, M.D., Mayo Clinic
- Investigators
- Daryl J Kor, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02835937
- Sponsor's protocol ID
- 15-006487
- Status last verified
- Feb 2019
- First submitted
- 14 Jul 2016
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 28359342
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Red Blood Cell Transfusion in the Ambulatory Setting: Impact on Home Functional Status
- ClinicalTrials.gov ID
- NCT02835937
- Acronym / sponsor ID
- 15-006487
- Conditions
- Red Blood Cell Transfusions, Anemia, Hematology, Oncology, Ambulatory Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Arizona State University
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 10 Nov 2017 (actual)
- Study completion
- 10 Nov 2017 (actual)
- First posted
- 18 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Do ambulatory RBC transfusions improve home functional status?
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transfuse | No intervention | –Patients will receive a transfusion under standard care |
| No-Transfuse | Experimental | Other: No-TransfusePatients will not receive a transfusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18 years
- At least on prior encounter in the AIC
- Planned RBC transfusion
Key exclusion criteria (8 listed)
- Refusal to provide informed consent
- Refusal by the health care team
- Acute ischemia (e.g. MI, CVA)
- Hemoglobin < 7.0 g/dL
- Active bleeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No-TransfusePatients will not receive an otherwise-indicated red blood cell transfusion | Other | No-Transfuse |
Primary outcome
Percent Change in Average Daily Physical Activity
Time frame: Baseline to 7 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Derived from this study: PubMed 28359342Murphree 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daryl J Kor principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No-Transfuse in people with Red Blood Cell Transfusions and Anemia, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in Average Daily Physical Activity (time frame: Baseline to 7 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02835937, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.