RBC TransfusionsNCT05482737
Clinical Impact of Red Cell Storage Age
An observational study of RBC Transfusions, run by University of Minnesota at 1 site in United States.
Trial summary
The recent four RCTs evaluating effects of RBC storage age on morbidity and mortality found no statistically significant adverse effects of longer stored RBC compared to shorter storage ages. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- RBC Transfusions
- How many people
- 33,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2019to 30 Aug 2024
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Subjects in the recent four RCTs who are 18 years or older and have received at least one RBC transfusion.
Who may be able to join
- Received at least one RBC transfusion
- >=18 years of age
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Clinical Impact of Red Cell Storage Age: Individual Patient Data Meta-Analysis of Four Recent Large Randomized Trials
The recent four RCTs evaluating effects of RBC storage age on morbidity and mortality found no statistically significant adverse effects of longer stored RBC compared to shorter storage ages. Unfortunately, none of these RCTs had sufficient numbers of subjects receiving RBC at either storage age extreme to identify consequences of RBC transfusion at these limits. To better investigate effects of RBC storage age on clinical outcomes, this study will perform secondary meta-analyses of merged common patient data elements -individual patient data (IPD) meta-analysis (IPDMA) - from the nearly 33,000 subjects enrolled in the four RCTs.
- Conditions
- RBC Transfusions
- Being tested
- no intervention
- Keywords
- RBC transfusions, storage age, meta-analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
This is an observational retrospective study (meta-analysis)
| Study group | Role | What they receive |
|---|---|---|
| Reference group | Transfused RBC stored 8-35 days Receives: Other: no intervention | |
| less than or equal 7 days | Transfused RBC stored =<7 days Receives: Other: no intervention | |
| more than 7 days | Transfused RBC stored <7 days Receives: Other: no intervention | |
| less that or equal 10 days | Transfused RBC stored =<10 days Receives: Other: no intervention | |
| more that 10 days | Transfused RBC stored >10 days Receives: Other: no intervention | |
| more than 35 days | Transfused RBC stored >35 days Receives: Other: no intervention | |
| less than or equal 35 days | Transfused RBC stored =<35 days Receives: Other: no intervention | |
| less than 18 days | Transfused RBC stored <18 days Receives: Other: no intervention | |
| more than or equal 18 days | Transfused RBC stored =>18 days Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Estimate the effect of transfused RBC storage-age on time to all-cause mortality
Measured: 28 days after transfusion
Hospital length of stay
Estimate the effect of transfused RBC storage-age on hospital stay
Measured: after transfusion through 28 days
Secondary outcomes (2)
All-cause mortality at 28 days for long-storage
all-cause mortality at 28 days comparing subjects who received (one or more) RBC unit ≥ 35 days vs. no unit > 35 days
Measured: 28 days after transfusion
28 day mortality for short-storage
28 day mortality for subjects who received (one or more) RBC unit ≤ 7 days vs. no unit ≤ 7 days
Measured: 28 days after transfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start1 Jul 2019
- Primary completion1 Aug 2023
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RBC TransfusionsStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 33,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie Steiner, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05482737
- Sponsor's protocol ID
- Pending 4
- Status last verified
- Oct 2024
- First submitted
- 27 Jul 2022
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Impact of Red Cell Storage Age: Individual Patient Data Meta-Analysis of Four Recent Large Randomized Trials
- ClinicalTrials.gov ID
- NCT05482737
- Acronym / sponsor ID
- Pending 4
- Conditions
- RBC Transfusions
- Keywords
- RBC transfusions, storage age, meta-analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33,000 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 1 Aug 2022 (actual)
- 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.
The recent four RCTs evaluating effects of RBC storage age on morbidity and mortality found no statistically significant adverse effects of longer stored RBC compared to shorter storage ages. Unfortunately, none of these RCTs had sufficient numbers of subjects receiving RBC at either storage age extreme to identify consequences of RBC transfusion at these limits. To better investigate effects of RBC storage age on clinical outcomes, this study will perform secondary meta-analyses of merged common patient data elements -individual patient data (IPD) meta-analysis (IPDMA) - from the nearly 33,000 subjects enrolled in the four RCTs.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Reference group | – | Other: no interventionTransfused RBC stored 8-35 days |
| less than or equal 7 days | – | Other: no interventionTransfused RBC stored =<7 days |
| more than 7 days | – | Other: no interventionTransfused RBC stored <7 days |
| less that or equal 10 days | – | Other: no interventionTransfused RBC stored =<10 days |
| more that 10 days | – | Other: no interventionTransfused RBC stored >10 days |
| more than 35 days | – | Other: no interventionTransfused RBC stored >35 days |
| less than or equal 35 days | – | Other: no interventionTransfused RBC stored =<35 days |
| less than 18 days | – | Other: no interventionTransfused RBC stored <18 days |
| more than or equal 18 days | – | Other: no interventionTransfused RBC stored =>18 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Subjects in the recent four RCTs who are 18 years or older and have received at least one RBC transfusion.
Key inclusion criteria (2 listed)
- Received at least one RBC transfusion
- >=18 years of age
Key exclusion criteria (1 listed)
- N/A
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 interventionThis is an observational retrospective study (meta-analysis) | Other | Reference group, less than 18 days, less than or equal 35 days, less than or equal 7 days, less that or equal 10 days, more than 35 days, more than 7 days, more than or equal 18 days, more that 10 days |
Primary outcome
All-cause mortality
Time frame: 28 days after transfusion
Estimate the effect of transfused RBC storage-age on time to all-cause mortality
Hospital length of stay
Time frame: after transfusion through 28 days
Estimate the effect of transfused RBC storage-age on hospital stay
2 secondary outcomes
All-cause mortality at 28 days for long-storage
Time frame: 28 days after transfusion
28 day mortality for short-storage
Time frame: 28 days after transfusion
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 3 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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.
Marie Steiner, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of RBC Transfusions, run by University of Minnesota 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 2 inclusion and 1 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 3 Oct 2024. 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?
All-cause mortality (time frame: 28 days after transfusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Oct 2024.