Clinical Impact of Red Cell Storage Age

NCT ID: NCT05482737

Last Updated: 2024-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

33000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-01

Study Completion Date

2024-08-30

Brief Summary

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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.

Detailed Description

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Conditions

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RBC Transfusions

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Reference group

Transfused RBC stored 8-35 days

no intervention

Intervention Type OTHER

This is an observational retrospective study (meta-analysis)

less than or equal 7 days

Transfused RBC stored =\<7 days

no intervention

Intervention Type OTHER

This is an observational retrospective study (meta-analysis)

more than 7 days

Transfused RBC stored \<7 days

no intervention

Intervention Type OTHER

This is an observational retrospective study (meta-analysis)

less that or equal 10 days

Transfused RBC stored =\<10 days

no intervention

Intervention Type OTHER

This is an observational retrospective study (meta-analysis)

more that 10 days

Transfused RBC stored \>10 days

no intervention

Intervention Type OTHER

This is an observational retrospective study (meta-analysis)

more than 35 days

Transfused RBC stored \>35 days

no intervention

Intervention Type OTHER

This is an observational retrospective study (meta-analysis)

less than or equal 35 days

Transfused RBC stored =\<35 days

no intervention

Intervention Type OTHER

This is an observational retrospective study (meta-analysis)

less than 18 days

Transfused RBC stored \<18 days

no intervention

Intervention Type OTHER

This is an observational retrospective study (meta-analysis)

more than or equal 18 days

Transfused RBC stored =\>18 days

no intervention

Intervention Type OTHER

This is an observational retrospective study (meta-analysis)

Interventions

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no intervention

This is an observational retrospective study (meta-analysis)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Received at least one RBC transfusion
* \>=18 years of age

Exclusion Criteria

* N/A
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marie Steiner, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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Pending 4

Identifier Type: -

Identifier Source: org_study_id

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