Platelet TransfusionRE-CCIPNCT03325140
Platelet Transfusions in Critically Ill Patient
An observational study of Platelet Transfusion and Critical Illness, run by University Hospital, Brest at 7 sites in France.
Trial summary
Between 10 and 15% of critically ill patients require platelet transfusion within their intensive care unit (ICU). Platelets (PLT) are given to prevent bleeding in thrombocytopenic patients or to treat bleeding as part of massive transfusion or in bleeding thrombocytopenic patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Platelet Transfusion, Critical Illness
- How many people
- 300 participants
- Where
- 7 sitesFrance
- Study dates
- 30 May 2018to 15 Dec 2019
- 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: Patients admitted to intensive care and receiving platelet transfusion whatever the reason for it.
Who may be able to join
- Patients admitted to intensive care and receiving at least one platelet transfusion in intensive care unit
Who cannot join
- Age less than 18
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites, 7 recruiting
- Recruiting
CHU d'Angers
Angers, 49100
Pierre ASFAR, Pr, pierre.asfar@chu-angers.fr
- Recruiting
CHRU de Brest
Brest, 29609
Aubron Cécile, cecile.aubron@chu-brest.fr
Olivier Huet, Pr
- Recruiting
CH des Pays de Morlaix
Morlaix, 29 672
Pierre-Yves EGRETEAU, 02 98 62 61 60, pyegreteau@ch-morlaix.fr
- Recruiting
CHU de Nantes
Nantes, 44093
LE MEUR Anthony, anthony.lemeur@chu-nantes.fr
- Recruiting
CHU de Rennes
Rennes, 35033
SEGUIN Philippe, philippe.seguin@chu-brest.fr
TADIE Jean-Marc
- Recruiting
CHU de Tours
Tours, 37044
EHRMANN Stephan, stephan.ehrmann@chu-tours.fr
- Recruiting
Chba Site de Vannes
Vannes, 56 017
Julien HUNTZINGER, 06-33-58-02-04, julienhuntzinger@hotmail.com
About this study
Official title: Platelet Transfusion Efficacy in Critically Ill Patients
Between 10 and 15% of critically ill patients require platelet transfusion within their intensive care unit (ICU).
Platelets (PLT) are given to prevent bleeding in thrombocytopenic patients or to treat bleeding as part of massive transfusion or in bleeding thrombocytopenic patients.
Read more
International and local guidelines (American Association of Blood Banks-AABB) are mainly based on experts' opinion. The efficacy of PLT transfusion in the ICU setting remains poorly studied and unknown and the administration of PLT may be associated with adverse effects including an increased risk of hospital acquired infection. Finally, the short PLT shelve-life may be responsible for inventory issues. Altogether, this makes very important to improve the evidence that support PLT transfusion in ICU patients.
This is a multicentre prospective observational study that aims to first determine PLT transfusion efficacy and to identify the parameters associated with transfusion efficacy and to analyse the compliance with international (and local) guidelines of PLT transfusion in ICU patients.
- Conditions
- Platelet Transfusion, Critical Illness
- Medical subject headings
- Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
platelet transfusion efficacy
corrected count platelet increment
Measured: between 18 hours and 28 days after transfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2017
- Study start30 May 2018
- Primary completion15 Dec 2019 (estimated)
- Study completion15 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Platelet TransfusionStudies 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
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03325140
- Sponsor's protocol ID
- RE-CCIP (29BRC17.0157)
- Acronym
- RE-CCIP
- Status last verified
- Jul 2019
- First submitted
- 21 Oct 2017
- Last updated
- 18 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Publications
Reizine F, Le Marec S, Le Meur A, Consigny M, Berteau F, Bodenes L, Geslain M, McQuilten Z, Le Niger C, Huntzinger J, Seguin P, Thibert JB, Simon D, Reignier J, Egreteau PY, Tadie JM, Huet O, Asfar P, Ehrmann S, Aubron C. Prophylactic platelet transfusion response in critically ill patients: a prospective multicentre observational study. Crit Care. 2023 Sep 27;27(1):373. doi: 10.1186/s13054-023-04650-z.
PubMed 37759268
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Transfusion Efficacy in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT03325140
- Acronym / sponsor ID
- RE-CCIP / RE-CCIP (29BRC17.0157)
- Conditions
- Platelet Transfusion, Critical Illness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 30 May 2018 (actual)
- Primary completion
- 15 Dec 2019 (estimated)
- Study completion
- 15 Dec 2019 (estimated)
- First posted
- 30 Oct 2017 (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.
Between 10 and 15% of critically ill patients require platelet transfusion within their intensive care unit (ICU).
Platelets (PLT) are given to prevent bleeding in thrombocytopenic patients or to treat bleeding as part of massive transfusion or in bleeding thrombocytopenic patients.
International and local guidelines (American Association of Blood Banks-AABB) are mainly based on experts' opinion. The efficacy of PLT transfusion in the ICU setting remains poorly studied and unknown and the administration of PLT may be associated with adverse effects including an increased risk of hospital acquired infection. Finally, the short PLT shelve-life may be responsible for inventory issues. Altogether, this makes very important to improve the evidence that support PLT transfusion in ICU patients.
This is a multicentre prospective observational study that aims to first determine PLT transfusion efficacy and to identify the parameters associated with transfusion efficacy and to analyse the compliance with international (and local) guidelines of PLT transfusion in ICU patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to intensive care and receiving platelet transfusion whatever the reason for it.
Key inclusion criteria (1 listed)
- Patients admitted to intensive care and receiving at least one platelet transfusion in intensive care unit
Key exclusion criteria (1 listed)
- Age less than 18
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
platelet transfusion efficacy
Time frame: between 18 hours and 28 days after transfusion
corrected count platelet increment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2019.
- Derived from this study: PubMed 37759268Reizine F, Le Marec S, Le Meur A, Consigny M, Berteau F, Bodenes L, Geslain M, McQuilten Z, Le Niger C, Huntzinger J, Seguin P, Thibert JB, Simon D, Reignier J, Egreteau PY, Tadie JM, Huet O, Asfar P, Ehrmann S, Aubron C. Prophylactic platelet transfusion response in critically ill patients: a prospective multicentre observational study. Crit Care. 2023 Sep 27;27(1):373. doi: 10.1186/s13054-023-04650-z.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Platelet Transfusion and Critical Illness, run by University Hospital, Brest at 7 sites 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 1 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: status not confirmed, as of the sponsor's last update on 18 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact AUBRON Cécile (+33 2 98 34 78 59, cecile.aubron@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
platelet transfusion efficacy (time frame: between 18 hours and 28 days after transfusion). 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 NCT03325140, which also lists 1 linked publication.
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 18 Jul 2019.