AnemiaMATERNCT06176105
Mortality After Transfusion of Ever-pregnant Donor Red Blood Cells
An observational study of Anemia, run by Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Anemia
- How many people
- 101,000 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Oct 2019to 1 Oct 2020
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- N.A.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Anemia
- Keywords
- Transfusion, Red blood cells, Sex mismatch, Pregnancy
- Medical subject headings
- Anemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
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.
Measured: 2015-2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2023
- Study start1 Oct 2019
- Primary completion1 Oct 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- 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
- 101,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- J van der Bom, Prof, Principal investigator, Jon J van Rood Center for Clinical Transfusion Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06176105
- Sponsor's protocol ID
- PPOC 18-03
- Acronym
- MATER
- Status last verified
- Mar 2019
- First submitted
- 22 Nov 2023
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Caram-Deelder C, Kreuger AL, Evers D, de Vooght KMK, van de Kerkhof D, Visser O, Pequeriaux NCV, Hudig F, Zwaginga JJ, van der Bom JG, Middelburg RA. Association of Blood Transfusion From Female Donors With and Without a History of Pregnancy With Mortality Among Male and Female Transfusion Recipients. JAMA. 2017 Oct 17;318(15):1471-1478. doi: 10.1001/jama.2017.14825.
PubMed 29049654Middelburg RA, Briet E, van der Bom JG. Mortality after transfusions, relation to donor sex. Vox Sang. 2011 Oct;101(3):221-9. doi: 10.1111/j.1423-0410.2011.01487.x. Epub 2011 Apr 8.
PubMed 21477152
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mortality After Transfusion of Ever-pregnant Donor Red Blood Cells
- ClinicalTrials.gov ID
- NCT06176105
- Acronym / sponsor ID
- MATER / PPOC 18-03
- Conditions
- Anemia
- Keywords
- Transfusion, Red blood cells, Sex mismatch, Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101,000 participants (actual)
- Lead sponsor
- Sanquin-LUMC J.J van Rood Center for Clinical Transfusion ResearchUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 19 Dec 2023 (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 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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
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.
Primary outcome
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.
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 19 Dec 2023.
- Background: PubMed 29049654Caram-Deelder C, Kreuger AL, Evers D, de Vooght KMK, van de Kerkhof D, Visser O, Pequeriaux NCV, Hudig F, Zwaginga JJ, van der Bom JG, Middelburg RA. Association of Blood Transfusion From Female Donors With and Without a History of Pregnancy With Mortality Among Male and Female Transfusion Recipients. JAMA. 2017 Oct 17;318(15):1471-1478. doi: 10.1001/jama.2017.14825.
- Background: PubMed 21477152Middelburg RA, Briet E, van der Bom JG. Mortality after transfusions, relation to donor sex. Vox Sang. 2011 Oct;101(3):221-9. doi: 10.1111/j.1423-0410.2011.01487.x. Epub 2011 Apr 8.
- 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.
J van der Bom, Prof principal investigator
Jon J van Rood Center for Clinical Transfusion Research
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 Anemia, run by Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research at 1 site in Netherlands.
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 19 Dec 2023. 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 Netherlands. 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?
Mortality (time frame: 2015-2018). 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 NCT06176105, which also lists 2 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 19 Dec 2023.