Critical CareIMIBNCT03041974
Impact of Microparticles in Blood on Transfused Patient Outcomes
An observational study of Critical Care, run by Centre Hospitalier Universitaire de Besancon.
Trial summary
During storage, red blood cells (RBCs) undergo changes collectively termed "Storage lesions". these changes may have an impact of the outcomes of transfused patients. One of these changes is the release of microparticles by RBCs and other blood cells types. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Care
- What is being tested?
- Red Blood Cell transfusion and Microparticles quantification
- Type of treatment
- Surgery or procedure
- How many people
- 280 participants
- Where
- No sites listed yet
- Study dates
- Mar 2011to Nov 2014
- 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
- No healthy volunteers
- Adult, Older adult
Study population: The patients included in the study are the patients enrolled, by french centers, in either arms of the ABLE trial.
Who may be able to join
None listed.
Who cannot join
- less than 18 years of age
- previously enrolled in the ABLE study
- has already been transfused with red cells during the current hospitalisation
- has an obvious terminal illness documented in the medical record with a life expectancy of less than 3 months
- has undergone routine cardiac surgical care
- decision to withdraw/withhold some critical care had been made
Show all 12Show fewer
- brain dead
- no red cells with a storage time of 7 days or less available in the blood bank that cannot be transported from the blood supplier
- Who require more than 1 unit of uncross-matched red cells
- With a known objection to blood transfusions
- With autologous blood donations
- Who pose difficulties in securing blood products (rare blood groups), and who are difficult to match
About this study
Official title: Cell-derived Microparticles in Red Blood Cell (RBC) Concentrates, and Their Potential Impact on Outcomes of Transfused Patients in Critical Care: a Prospective Multicentre National Cohort Study of Patients Included in the ABLE Trial
During storage, red blood cells (RBCs) undergo changes collectively termed "Storage lesions". these changes may have an impact of the outcomes of transfused patients. One of these changes is the release of microparticles by RBCs and other blood cells types. The aim of the study is to (1) quantify red cell- and platelet-derived microparticles in RBC concentrates, and (2) evaluate the impact of transfused microparticles (MPs) on survival and post-transfusion complications in critical care patients participating in the ABLE trial (ISRCTN44878718).
Read the detailed description
During conservation of red blood cell concentrates, red blood cells (RBCs) undergo biochemical and morphological changes that have been well described, and are collectively termed " storage lesions ". The exact effects of these lesions in terms of beneficial or deleterious implications in the recipient remain to be elucidated. However, several retrospective studies in targeted populations suggest that an increase in the duration of RBC conservation could lead to an increase in morbidity and mortality in transfused patients. The multicenter, prospective trial ABLE (Age of Blood Evaluation, ISRCTN44878718) aimed to evaluate in a randomised clinical trial, the impact of the age of transfused RBC concentrates on several outcomes in critical care patients.
Among the modifications that RBCs undergo during storage, the generation of microparticles from red blood cellsRBCs or residual platelets present in the blood concentrate has never been evaluated in a prospective clinical study. It has been reported that the number of red cell-derived microparticles (RMPs) present in stored blood increases with storage duration. In vivo, microparticles MPs appear to be increasingly involved in disease processes, notably due to their pro-inflammatory and pro-coagulant effects. Furthermore, it has been shown that the antigens of the Rhesus group are expressed on the RBC derived microparticles, and the investigative team has shown that microparticles derived from elsewhere (endothelial cells) are capable of activating cells which are important in the induction of immune responses (dendritic cells). Thus, transfusing red blood cell derived microparticles could participate in post-transfusional alloimmunization which may also be evaluated in this study.
The aim of the IMIB study is to (1) quantify red cell- and platelet-derived microparticles MPs in RBC concentrates, and (2) evaluate the impact of the quantity of transfused microparticles (MPs) on survival and several outcomes in the patients enrolled in the ABLE trial in France.
Other aims are to investigate the relationship between the number of microparticles in RBC units and (1) the age of RBC, (2) donors characteristics, (3) the procedures used to prepare the blood products (to define a potential new "lesion storage" marker).
- Conditions
- Critical Care
- Being tested
- Red Blood Cell transfusion, Microparticles quantification
- Keywords
- Red Blood Cell Transfusion, Cell-Derived Microparticles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red Blood Cell transfusionProcedure or surgery
Microparticles quantificationProcedure or surgery
Flow cytometric quantification of microparticles in transfused blood
| Study group | Role | What they receive |
|---|---|---|
| Transfused critical care patients | Patients included in the Age of BLood Evaluation (ABLE) trial in either arms and included in a French center. Receives: Procedure: Red Blood Cell transfusion; Procedure: Microparticles quantification |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
Measured: 90 days
Secondary outcomes (3)
All cause mortality
Measured: 28 days, 6 months
Multi organ dysfunction score
Measured: 6 months
Nosocomial infection
including Nosocomial pneumonia, Deep tissue infections (e.g. peritonitis, mediastinitis), Bacteraemia from organisms not considered normal skin flora and judged important enough to treat by the attending team, as measured while in the ICU
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2017 (estimated)
- Study startMar 2011
- Primary completionMay 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical CareStudies 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
- Prospective
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francine Garnache-Ottou, PharmD, PhD, Principal investigator, Etablissement Français du Sang, Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03041974
- Sponsor's protocol ID
- IMIB PHRC 2013
- Acronym
- IMIB
- Status last verified
- Feb 2017
- First submitted
- 12 Sep 2016
- Last updated
- 3 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cell-derived Microparticles in Red Blood Cell (RBC) Concentrates, and Their Potential Impact on Outcomes of Transfused Patients in Critical Care: a Prospective Multicentre National Cohort Study of Patients Included in the ABLE Trial
- ClinicalTrials.gov ID
- NCT03041974
- Acronym / sponsor ID
- IMIB / IMIB PHRC 2013
- Conditions
- Critical Care
- Keywords
- Red Blood Cell Transfusion, Cell-Derived Microparticles
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- May 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 3 Feb 2017 (estimated)
- 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.
During storage, red blood cells (RBCs) undergo changes collectively termed "Storage lesions". these changes may have an impact of the outcomes of transfused patients. One of these changes is the release of microparticles by RBCs and other blood cells types. The aim of the study is to (1) quantify red cell- and platelet-derived microparticles in RBC concentrates, and (2) evaluate the impact of transfused microparticles (MPs) on survival and post-transfusion complications in critical care patients participating in the ABLE trial (ISRCTN44878718).
Detailed description
During conservation of red blood cell concentrates, red blood cells (RBCs) undergo biochemical and morphological changes that have been well described, and are collectively termed " storage lesions ". The exact effects of these lesions in terms of beneficial or deleterious implications in the recipient remain to be elucidated. However, several retrospective studies in targeted populations suggest that an increase in the duration of RBC conservation could lead to an increase in morbidity and mortality in transfused patients. The multicenter, prospective trial ABLE (Age of Blood Evaluation, ISRCTN44878718) aimed to evaluate in a randomised clinical trial, the impact of the age of transfused RBC concentrates on several outcomes in critical care patients.
Among the modifications that RBCs undergo during storage, the generation of microparticles from red blood cellsRBCs or residual platelets present in the blood concentrate has never been evaluated in a prospective clinical study. It has been reported that the number of red cell-derived microparticles (RMPs) present in stored blood increases with storage duration. In vivo, microparticles MPs appear to be increasingly involved in disease processes, notably due to their pro-inflammatory and pro-coagulant effects. Furthermore, it has been shown that the antigens of the Rhesus group are expressed on the RBC derived microparticles, and the investigative team has shown that microparticles derived from elsewhere (endothelial cells) are capable of activating cells which are important in the induction of immune responses (dendritic cells). Thus, transfusing red blood cell derived microparticles could participate in post-transfusional alloimmunization which may also be evaluated in this study.
The aim of the IMIB study is to (1) quantify red cell- and platelet-derived microparticles MPs in RBC concentrates, and (2) evaluate the impact of the quantity of transfused microparticles (MPs) on survival and several outcomes in the patients enrolled in the ABLE trial in France.
Other aims are to investigate the relationship between the number of microparticles in RBC units and (1) the age of RBC, (2) donors characteristics, (3) the procedures used to prepare the blood products (to define a potential new "lesion storage" marker).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transfused critical care patients | – | Procedure: Red Blood Cell transfusion, Procedure: Microparticles quantificationPatients included in the Age of BLood Evaluation (ABLE) trial in either arms and included in a French center. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients included in the study are the patients enrolled, by french centers, in either arms of the ABLE trial.
Key inclusion criteria (0 listed)
Key exclusion criteria (12 listed)
- less than 18 years of age
- previously enrolled in the ABLE study
- has already been transfused with red cells during the current hospitalisation
- has an obvious terminal illness documented in the medical record with a life expectancy of less than 3 months
- has undergone routine cardiac surgical care
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 |
|---|---|---|
| Red Blood Cell transfusion | Procedure or surgery | Transfused critical care patients |
| Microparticles quantificationFlow cytometric quantification of microparticles in transfused blood | Procedure or surgery | Transfused critical care patients |
Primary outcome
All cause mortality
Time frame: 90 days
3 secondary outcomes
All cause mortality
Time frame: 28 days, 6 months
Multi organ dysfunction score
Time frame: 6 months
Nosocomial infection
Time frame: 6 months
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 Feb 2017.
- 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.
Francine Garnache-Ottou, PharmD, PhD principal investigator
Etablissement Français du Sang, Besançon
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Care, run by Centre Hospitalier Universitaire de Besancon.
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 0 inclusion and 12 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 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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: 90 days). 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 Feb 2017.