Transfusion Related ComplicationPATMORENCT03934112
Impact of Transfusional Practice on the Morbidity and Mortality of Patients in Intensive Care Unit
An observational study of Transfusion Related Complication, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
This study will allow correlating transfusion monitoring and patients' prognostic according to the chosen outcome criteria. These data could thus represent a basis for transfusion recommendations, except for intensive care and vital emergencies. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Transfusion Related Complication
- How many people
- 150,000 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jan 2020to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients treated in medical and surgical resuscitation units of Besançon and Dijon university hospitals during the study period (from 01/01/2012 to 31/12/2017) are concerned.
Who may be able to join
- Patient admitted to medical and surgical resuscitation units of Besançon and Dijon university hospitals, all causes considered
- Patient admitted between 1st January 2012 to 31st December 2017
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Besançon
Besançon
Maxime Desmaret, 00000000, mdesmaret@chu-besancon.fr
About this study
Official title: Impact of Transfusional Practice on the Morbidity and Mortality of Patients in Intensive Care
This study will allow correlating transfusion monitoring and patients' prognostic according to the chosen outcome criteria.
These data could thus represent a basis for transfusion recommendations, except for intensive care and vital emergencies.
It will also bring information about the actual transfusion monitoring in intensive care unit (ICU), in the period following the stay in the ICU and after hospital discharge.
- Conditions
- Transfusion Related Complication
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival at 90 days after leaving ICU
All-cause mortality 90 days after leaving ICU
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start3 Jan 2020
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transfusion Related ComplicationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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
- 150,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03934112
- Sponsor's protocol ID
- API/2016/72
- Acronym
- PATMORE
- Status last verified
- Sep 2024
- First submitted
- 26 Apr 2019
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Transfusional Practice on the Morbidity and Mortality of Patients in Intensive Care
- ClinicalTrials.gov ID
- NCT03934112
- Acronym / sponsor ID
- PATMORE / API/2016/72
- Conditions
- Transfusion Related Complication
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150,000 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 3 Jan 2020 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 1 May 2019 (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.
This study will allow correlating transfusion monitoring and patients' prognostic according to the chosen outcome criteria.
These data could thus represent a basis for transfusion recommendations, except for intensive care and vital emergencies.
It will also bring information about the actual transfusion monitoring in intensive care unit (ICU), in the period following the stay in the ICU and after hospital discharge.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients treated in medical and surgical resuscitation units of Besançon and Dijon university hospitals during the study period (from 01/01/2012 to 31/12/2017) are concerned.
Key inclusion criteria (2 listed)
- Patient admitted to medical and surgical resuscitation units of Besançon and Dijon university hospitals, all causes considered
- Patient admitted between 1st January 2012 to 31st December 2017
Key exclusion criteria (0 listed)
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
Survival at 90 days after leaving ICU
Time frame: Day 90
All-cause mortality 90 days after leaving ICU
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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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.
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 Transfusion Related Complication, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
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 0 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: looking for participants now, as of the sponsor's last update on 19 Sep 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maxime Desmarets, PhD (0033 381 218 359, maxime.desmarets@univ-fcomte.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival at 90 days after leaving ICU (time frame: Day 90). 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 19 Sep 2024.