Bone Marrow Failure SyndromePhase 3ABC-TOPNCT02393508
The Impact of Red Cell Age on Product Utilization in the Chronically Transfused Outpatient Population
A Phase 3 study testing Fresh Human Red Blood Cells and Aged Human Red Blood Cells in people with Bone Marrow Failure Syndrome, run by University of Calgary.
Trial summary
In this study, the investigators will be evaluating the impact of red blood cell age in patients receiving chronic blood transfusions in the outpatient setting. This study will have a double-bind, randomized trial design, meaning that the investigators and participants will not be told the group assignment at study… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Marrow Failure Syndrome
- What is being tested?
- Fresh Human Red Blood Cells and Aged Human Red Blood Cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Dec 2017
- Phase
- Phase 3
- 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
- Patients requiring outpatient chronic red cell transfusions (2 or more red blood cell units per month for at least 3 consecutive months) in an ambulatory clinic within the Calgary Zone
Who cannot join
- prerequisite for fresh or irradiated blood due to a pre-existing medical reason
- hemodialysis dependence
- chronic disease that has acutely decompensated, with a life expectancy of less than 3 months
About this study
In this study, the investigators will be evaluating the impact of red blood cell age in patients receiving chronic blood transfusions in the outpatient setting. This study will have a double-bind, randomized trial design, meaning that the investigators and participants will not be told the group assignment at study enrollment.
Study participants will be randomly divided into two groups (50% of participants in each group) by a computer generated block randomization schema. The 'fresh blood' group will receive blood units that are 7 or less from the time of donor collection, and the 'aged blood' group will receive blood units that are greater than 21 to 42 days from the time of donor collection. The number of units of blood transfused will be decided based on the participant's hemoglobin level before blood transfusion.
Read more
The primary goal of our study is to compare annual red blood cell product use (the number of units given per patient in a year). The investigators will also be comparing groups to evaluate the transfusion reaction frequency, iron burden (based on the level of ferritin in the blood), overall transfusion and care cost difference, and participant time spent in outpatient departments.
Our hypothesis is that use of fresh blood in chronically transfused patients will lead to a decrease the in red cell transfusion rate, with subsequent clinical benefits including reduction of transfusion reaction frequency and systemic iron burden.
This study will be taking place within the Calgary Zone of Alberta Health Services only.
Read the detailed description
Background: Chronically transfused medical outpatients comprise a significant proportion of transfusion recipients annually. At this time, the impact of red cell transfusion on patient outcomes in this patient population is unknown.
Objective: Our goal is to prospectively evaluate impact of red cell age on product utilization in a cohort of chronically transfused medical outpatients randomized to receive red blood cells that are fresh (≤ 7 days from collection) or aged (>21-42 days from collection). To our knowledge, no other studies with a similar design or objective have been published.
Patient population and study design: Patients meeting eligibility criteria will be invited to participate in our study. Our chronically transfused outpatient population is defined as adults who are receiving 2 or more red cell units per month for at least 3 consecutive months in an ambulatory clinic setting within the Calgary Zone.
We plan to incorporate both prospective and retrospective data collection and analysis in our study design. All eligible, consenting participants will be randomized into one of the two study arms. Investigators and participants will be blinded to participant group assignment.
Laboratory parameters and red cell transfusion: Parameters of usual pre-transfusion bloodwork will be followed, including complete blood count (CBC) and ferritin levels. Red cell transfusion volumes for chronic transfusion throughout the study will be determined according to a locally established protocol to achieve a post-transfusion hemoglobin (Hb) of 95-105 g/dL. Given that 1 adult unit of red cells raises the baseline Hb by approximately 10 g/L, the following volumes will be given to patients during a single visit based on their pre-transfusion CBC: Hb <75 = 3 units, Hb 75-84 = 2 units, Hb 85-94 = 1 unit, Hb ≥95 = no transfusion. A routine post-transfusion CBC will not be performed. According to usual care, participants will have a standing order to perform a CBC at least weekly, or if they have subjective symptoms of anemia to help guide subsequent transfusions.
Study participants will receive blood transfusion in usual locations designated within the Calgary Zone for administration of chronic blood transfusions. These include medical daycare units at the Foothills Medical Center, Tom Baker Cancer Center, Peter Lougheed Center, and South Health Campus. Nurses will administer blood transfusions according to standard practice, without change in transfusion protocol despite patient study participation.
Duration of participation will be 1 year from the time of enrollment. Participant health record access will be required for collection of demographic information and retrospective data involving any transfusions received within 1 year prior to enrollment to establish transfusion chronicity and health patterns. Outcomes will be based on a comparison of results between the study groups. Prospectively collected data based on red cell age will additionally be compared to retrospective transfusion related information (including red cell transfusion frequency and blood age) from within 1 year from the time of enrollment, if available. We plan to enroll a maximum total of 60 participants, with assignment of 30 patients into each group.
- Conditions
- Bone Marrow Failure Syndrome
- Being tested
- Fresh Human Red Blood Cells, Aged Human Red Blood Cells
- Keywords
- transfusion, red blood cell, transfusion reaction, quality of life
- Medical subject headings
- Bone Marrow Failure Disorders, Transfusion Reaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fresh Human Red Blood CellsOther
Red cell units for transfusion will be acquired from Canadian Blood Services (CBS), as a part of their usual stock to the Calgary Zone. Blood will be processed and prepared by CBS according to their standard protocol. The red cell units assigned to patients as a part of this trial will not be manipulated in any way prior to participant transfusion.
Aged Human Red Blood CellsOther
Red cell units for transfusion will be acquired from Canadian Blood Services (CBS), as a part of their usual stock to the Calgary Zone. Blood will be processed and prepared by CBS according to their standard protocol. The red cell units assigned to patients as a part of this trial will not be manipulated in any way prior to participant transfusion.
| Study group | Role | What they receive |
|---|---|---|
| Fresh Human Red Blood Cells | Active comparator | Participants will receive transfusion of human donor red blood cells that are less than or equal to 7 days of age from the time of donation. Receives: Other: Fresh Human Red Blood Cells |
| Aged Human Red Blood Cells | Active comparator | Participants will receive transfusion of human donor red blood cells that are greater than 21 days and up to a maximum of 42 days of age from the time of donation. Receives: Other: Aged Human Red Blood Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Red blood cell transfusion rate
Product utilization, comparing the number and frequency of red blood cell units transfused to the chronically transfused outpatient population eligible for trial participation
Measured: 1 year from the time of enrollment
Secondary outcomes (4)
Ferritin burden
Based on results of laboratory test results available in the participant's electronic medical record, as ordered as a part of standard care by the primary hematologist
Measured: At enrollment, 3 months, 6 months, 9 months and 12 months
Total cost of blood product transfusion
Approximate sum of the cost of blood products transfused and nursing services required in the outpatient hospital treatment rooms when transfusions are administered throughout the study period
Measured: 1 year from the time of enrollment
Number of hours spent receiving blood products
Sum of the number of patient hours spent receiving transfusions in the hospital treatment room setting
Measured: 1 year from the time of enrollment
Transfusion reaction frequency
Number and type of transfusion reactions experienced by patients receiving transfusions throughout the study period, as reported to transfusion medicine by nursing, according to standard practice protocols
Measured: 1 year from the time of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2015 (estimated)
- Study startSep 2015
- Primary completionMar 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Bone Marrow Failure SyndromeStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oksana Prokopchuk-Gauk, University of Calgary
- Investigators
- Meer-Taher Shabani-Rad, MD, FRCPC, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02393508
- Sponsor's protocol ID
- 18-16748
- Acronym
- ABC-TOP
- Status last verified
- Dec 2015
- First submitted
- 5 Mar 2015
- Last updated
- 22 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Hebert PC, Chin-Yee I, Fergusson D, Blajchman M, Martineau R, Clinch J, Olberg B; Canadian Critical Care Trials Group. A pilot trial evaluating the clinical effects of prolonged storage of red cells. Anesth Analg. 2005 May;100(5):1433-1458. doi: 10.1213/01.ANE.0000148690.48803.27.
PubMed 15845701Taylor RW, O'Brien J, Trottier SJ, Manganaro L, Cytron M, Lesko MF, Arnzen K, Cappadoro C, Fu M, Plisco MS, Sadaka FG, Veremakis C. Red blood cell transfusions and nosocomial infections in critically ill patients. Crit Care Med. 2006 Sep;34(9):2302-8; quiz 2309. doi: 10.1097/01.CCM.0000234034.51040.7F.
PubMed 16849995Weinberg JA, McGwin G Jr, Griffin RL, Huynh VQ, Cherry SA 3rd, Marques MB, Reiff DA, Kerby JD, Rue LW 3rd. Age of transfused blood: an independent predictor of mortality despite universal leukoreduction. J Trauma. 2008 Aug;65(2):279-82; discussion 282-4. doi: 10.1097/TA.0b013e31817c9687.
PubMed 18695462Spinella PC, Carroll CL, Staff I, Gross R, Mc Quay J, Keibel L, Wade CE, Holcomb JB. Duration of red blood cell storage is associated with increased incidence of deep vein thrombosis and in hospital mortality in patients with traumatic injuries. Crit Care. 2009;13(5):R151. doi: 10.1186/cc8050. Epub 2009 Sep 22.
PubMed 19772604Koch CG, Li L, Sessler DI, Figueroa P, Hoeltge GA, Mihaljevic T, Blackstone EH. Duration of red-cell storage and complications after cardiac surgery. N Engl J Med. 2008 Mar 20;358(12):1229-39. doi: 10.1056/NEJMoa070403.
PubMed 18354101Mynster T, Nielsen HJ. The impact of storage time of transfused blood on postoperative infectious complications in rectal cancer surgery. Danish RANX05 Colorectal Cancer Study Group. Scand J Gastroenterol. 2000 Feb;35(2):212-7. doi: 10.1080/003655200750024416.
PubMed 10720122Yuruk K, Milstein DM, Bezemer R, Bartels SA, Biemond BJ, Ince C. Transfusion of banked red blood cells and the effects on hemorrheology and microvascular hemodynamics in anemic hematology outpatients. Transfusion. 2013 Jun;53(6):1346-52. doi: 10.1111/j.1537-2995.2012.03905.x. Epub 2012 Sep 24.
PubMed 22998160Triulzi DJ, Yazer MH. Clinical studies of the effect of blood storage on patient outcomes. Transfus Apher Sci. 2010 Aug;43(1):95-106. doi: 10.1016/j.transci.2010.05.013. Epub 2010 Jul 24.
PubMed 20656558
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Red Cell Age on Product Utilization in the Chronically Transfused Outpatient Population
- ClinicalTrials.gov ID
- NCT02393508
- Acronym / sponsor ID
- ABC-TOP / 18-16748
- Conditions
- Bone Marrow Failure Syndrome
- Keywords
- transfusion, red blood cell, transfusion reaction, quality of life
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 19 Mar 2015 (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.
In this study, the investigators will be evaluating the impact of red blood cell age in patients receiving chronic blood transfusions in the outpatient setting. This study will have a double-bind, randomized trial design, meaning that the investigators and participants will not be told the group assignment at study enrollment.
Study participants will be randomly divided into two groups (50% of participants in each group) by a computer generated block randomization schema. The 'fresh blood' group will receive blood units that are 7 or less from the time of donor collection, and the 'aged blood' group will receive blood units that are greater than 21 to 42 days from the time of donor collection. The number of units of blood transfused will be decided based on the participant's hemoglobin level before blood transfusion.
The primary goal of our study is to compare annual red blood cell product use (the number of units given per patient in a year). The investigators will also be comparing groups to evaluate the transfusion reaction frequency, iron burden (based on the level of ferritin in the blood), overall transfusion and care cost difference, and participant time spent in outpatient departments.
Our hypothesis is that use of fresh blood in chronically transfused patients will lead to a decrease the in red cell transfusion rate, with subsequent clinical benefits including reduction of transfusion reaction frequency and systemic iron burden.
This study will be taking place within the Calgary Zone of Alberta Health Services only.
Detailed description
Background: Chronically transfused medical outpatients comprise a significant proportion of transfusion recipients annually. At this time, the impact of red cell transfusion on patient outcomes in this patient population is unknown.
Objective: Our goal is to prospectively evaluate impact of red cell age on product utilization in a cohort of chronically transfused medical outpatients randomized to receive red blood cells that are fresh (≤ 7 days from collection) or aged (>21-42 days from collection). To our knowledge, no other studies with a similar design or objective have been published.
Patient population and study design: Patients meeting eligibility criteria will be invited to participate in our study. Our chronically transfused outpatient population is defined as adults who are receiving 2 or more red cell units per month for at least 3 consecutive months in an ambulatory clinic setting within the Calgary Zone.
We plan to incorporate both prospective and retrospective data collection and analysis in our study design. All eligible, consenting participants will be randomized into one of the two study arms. Investigators and participants will be blinded to participant group assignment.
Laboratory parameters and red cell transfusion: Parameters of usual pre-transfusion bloodwork will be followed, including complete blood count (CBC) and ferritin levels. Red cell transfusion volumes for chronic transfusion throughout the study will be determined according to a locally established protocol to achieve a post-transfusion hemoglobin (Hb) of 95-105 g/dL. Given that 1 adult unit of red cells raises the baseline Hb by approximately 10 g/L, the following volumes will be given to patients during a single visit based on their pre-transfusion CBC: Hb <75 = 3 units, Hb 75-84 = 2 units, Hb 85-94 = 1 unit, Hb ≥95 = no transfusion. A routine post-transfusion CBC will not be performed. According to usual care, participants will have a standing order to perform a CBC at least weekly, or if they have subjective symptoms of anemia to help guide subsequent transfusions.
Study participants will receive blood transfusion in usual locations designated within the Calgary Zone for administration of chronic blood transfusions. These include medical daycare units at the Foothills Medical Center, Tom Baker Cancer Center, Peter Lougheed Center, and South Health Campus. Nurses will administer blood transfusions according to standard practice, without change in transfusion protocol despite patient study participation.
Duration of participation will be 1 year from the time of enrollment. Participant health record access will be required for collection of demographic information and retrospective data involving any transfusions received within 1 year prior to enrollment to establish transfusion chronicity and health patterns. Outcomes will be based on a comparison of results between the study groups. Prospectively collected data based on red cell age will additionally be compared to retrospective transfusion related information (including red cell transfusion frequency and blood age) from within 1 year from the time of enrollment, if available. We plan to enroll a maximum total of 60 participants, with assignment of 30 patients into each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fresh Human Red Blood Cells | Active comparator | Other: Fresh Human Red Blood CellsParticipants will receive transfusion of human donor red blood cells that are less than or equal to 7 days of age from the time of donation. |
| Aged Human Red Blood Cells | Active comparator | Other: Aged Human Red Blood CellsParticipants will receive transfusion of human donor red blood cells that are greater than 21 days and up to a maximum of 42 days of age from the time of donation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients requiring outpatient chronic red cell transfusions (2 or more red blood cell units per month for at least 3 consecutive months) in an ambulatory clinic within the Calgary Zone
Key exclusion criteria (3 listed)
- prerequisite for fresh or irradiated blood due to a pre-existing medical reason
- hemodialysis dependence
- chronic disease that has acutely decompensated, with a life expectancy of less than 3 months
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 |
|---|---|---|
| Fresh Human Red Blood CellsRed cell units for transfusion will be acquired from Canadian Blood Services (CBS), as a part of their usual stock to the Calgary Zone. Blood will be processed and prepared by CBS according to their standard protocol. The red cell units assigned to patients as a part of this trial will not be manipulated in any way prior to participant transfusion. | Other | Fresh Human Red Blood Cells |
| Aged Human Red Blood CellsRed cell units for transfusion will be acquired from Canadian Blood Services (CBS), as a part of their usual stock to the Calgary Zone. Blood will be processed and prepared by CBS according to their standard protocol. The red cell units assigned to patients as a part of this trial will not be manipulated in any way prior to participant transfusion. | Other | Aged Human Red Blood Cells |
Primary outcome
Red blood cell transfusion rate
Time frame: 1 year from the time of enrollment
Product utilization, comparing the number and frequency of red blood cell units transfused to the chronically transfused outpatient population eligible for trial participation
4 secondary outcomes
Ferritin burden
Time frame: At enrollment, 3 months, 6 months, 9 months and 12 months
Total cost of blood product transfusion
Time frame: 1 year from the time of enrollment
Number of hours spent receiving blood products
Time frame: 1 year from the time of enrollment
Transfusion reaction frequency
Time frame: 1 year from the time of enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2015.
- Background: PubMed 15845701Hebert PC, Chin-Yee I, Fergusson D, Blajchman M, Martineau R, Clinch J, Olberg B; Canadian Critical Care Trials Group. A pilot trial evaluating the clinical effects of prolonged storage of red cells. Anesth Analg. 2005 May;100(5):1433-1458. doi: 10.1213/01.ANE.0000148690.48803.27.
- Background: PubMed 16849995Taylor RW, O'Brien J, Trottier SJ, Manganaro L, Cytron M, Lesko MF, Arnzen K, Cappadoro C, Fu M, Plisco MS, Sadaka FG, Veremakis C. Red blood cell transfusions and nosocomial infections in critically ill patients. Crit Care Med. 2006 Sep;34(9):2302-8; quiz 2309. doi: 10.1097/01.CCM.0000234034.51040.7F.
- Background: PubMed 18695462Weinberg JA, McGwin G Jr, Griffin RL, Huynh VQ, Cherry SA 3rd, Marques MB, Reiff DA, Kerby JD, Rue LW 3rd. Age of transfused blood: an independent predictor of mortality despite universal leukoreduction. J Trauma. 2008 Aug;65(2):279-82; discussion 282-4. doi: 10.1097/TA.0b013e31817c9687.
- Background: PubMed 19772604Spinella PC, Carroll CL, Staff I, Gross R, Mc Quay J, Keibel L, Wade CE, Holcomb JB. Duration of red blood cell storage is associated with increased incidence of deep vein thrombosis and in hospital mortality in patients with traumatic injuries. Crit Care. 2009;13(5):R151. doi: 10.1186/cc8050. Epub 2009 Sep 22.
- Background: PubMed 18354101Koch CG, Li L, Sessler DI, Figueroa P, Hoeltge GA, Mihaljevic T, Blackstone EH. Duration of red-cell storage and complications after cardiac surgery. N Engl J Med. 2008 Mar 20;358(12):1229-39. doi: 10.1056/NEJMoa070403.
- Background: PubMed 10720122Mynster T, Nielsen HJ. The impact of storage time of transfused blood on postoperative infectious complications in rectal cancer surgery. Danish RANX05 Colorectal Cancer Study Group. Scand J Gastroenterol. 2000 Feb;35(2):212-7. doi: 10.1080/003655200750024416.
- Background: PubMed 22998160Yuruk K, Milstein DM, Bezemer R, Bartels SA, Biemond BJ, Ince C. Transfusion of banked red blood cells and the effects on hemorrheology and microvascular hemodynamics in anemic hematology outpatients. Transfusion. 2013 Jun;53(6):1346-52. doi: 10.1111/j.1537-2995.2012.03905.x. Epub 2012 Sep 24.
- Background: PubMed 20656558Triulzi DJ, Yazer MH. Clinical studies of the effect of blood storage on patient outcomes. Transfus Apher Sci. 2010 Aug;43(1):95-106. doi: 10.1016/j.transci.2010.05.013. Epub 2010 Jul 24.
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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.
Meer-Taher Shabani-Rad, MD, FRCPC principal investigator
University of Calgary
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fresh Human Red Blood Cells and Aged Human Red Blood Cells in people with Bone Marrow Failure Syndrome, run by University of Calgary.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 22 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Red blood cell transfusion rate (time frame: 1 year from the time of enrollment). 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 NCT02393508, which also lists 8 linked publications.
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 22 Dec 2015.