Mortality After Transfusion of Ever-pregnant Donor Red Blood Cells (MATER)

December 18, 2023 updated by: Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research
The MATER study is an observational cohort study on first ever transfusion recipients in six hospitals in the Netherlands, with information collected on both donor and patient characteristics. We aim to further specify which combination of characteristics of both donors and patients determine the increased risk of mortality after blood transfusions.

Study Overview

Status

Completed

Conditions

Detailed Description

Background In 2011, a link between donor sex and death of transfusion recipients was observed in red blood cell transfusions (Middelburg et al., Vox Sanquinis, 2011). This was further investigated by Caram-Deelder et al., who showed the transfusion of red blood cells from ever-pregnant donors was associated with higher mortality in young men (with age up to 50 years) (Caram-Deelder et al., JAMA, 2017). However, the biological mechanisms explaining this association remained unclear. More data is needed to be able to specify which combination of characteristics of both donors and patients determines this increased risk of mortality after red blood cell transfusions. Therefore, the MATER study was initiated: 'Mortality After Transfusion of Ever-pregnant donor Red blood cells'. Here, we aim to validate previous research on the association between donor pregnancy history and transfusion recipient mortality.

Rationale Red blood cells constitute the biggest part of the blood supply. They are currently transfused without consideration of the sex of the blood donor and the recipient. Recent evidence shows such a policy to be associated with increased mortality in male recipients of red blood cells from female donors with a history of pregnancy. This project aims to find clues for the biological mechanism behind this association. This knowledge will allow for more personalized future transfusion strategies that will minimize both side effects and associated mortality of recipients of red blood cell transfusions.

Methodology First-ever transfusion recipients in the Netherlands between 2005 and 2018 which were performed in the hospitals participating in the R-FACT study will be included in this study. All blood donations and the corresponding donors linked to these recipients will be included in this study. Cox regression analysis will be used to assess the effect of donor pregnancy on transfusion recipient mortality. This analysis method allows modelling the relation between exposure (donor pregnancy history), outcome (mortality), and confounders (e.g. total number of transfusions, year of transfusion, ABO and Rh blood type, sex of the patient, and hospital) taking into account that exposure and confounders vary over time. Pregnancy history will be investigated as number of pregnancies, time since last pregnancy, different partners and type of pregnancy (i.e. boy versus girl pregnancies, outcome of pregnancy). The hazard ratio will be presented for exposure to blood products with different characteristics, stratified by patient age, sex and (if possible) transfusion indication. Effect modification by storage time will also be investigated.

Study Type

Observational

Enrollment (Actual)

101000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Sanquin blood bank

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

First ever red blood cell transfusion recipients in the Netherlands between 20-03-2004 and 31-12-2018 which were performed in the hospitals participating in the R-FACT study will be included in this study. All blood donations and the corresponding donors linked to these recipients will be included in this study.

Description

Inclusion Criteria:

  • have received a first transfusion between 20-03-2004 and 31-12-2018 in one of the hospitals participating in the R-FACT study OR
  • have donated blood for a blood product which was used in one of the hospitals participating in the R-FACT study between 20-03-2004 and 31-12-2018

Exclusion Criteria:

  • N.A.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 2015-2018
In total, this cohort contains data on over 100,000 first-ever transfusion recipients and their received transfusions from six hospitals in the Netherlands, with information collected on both donor and patient characteristics.
2015-2018

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research

Investigators

  • Principal Investigator: J van der Bom, Prof, Jon J van Rood Center for Clinical Transfusion Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2019

Primary Completion (Actual)

October 1, 2020

Study Completion (Actual)

October 1, 2020

Study Registration Dates

First Submitted

November 22, 2023

First Submitted That Met QC Criteria

December 18, 2023

First Posted (Estimated)

December 19, 2023

Study Record Updates

Last Update Posted (Estimated)

December 19, 2023

Last Update Submitted That Met QC Criteria

December 18, 2023

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PPOC 18-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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