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Platelet Transfusions in Critically Ill Patient (RE-CCIP)

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ClinicalTrials.gov Identifier: NCT03325140
Recruitment Status : Recruiting
First Posted : October 30, 2017
Last Update Posted : October 10, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

Brief 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.

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.


Condition or disease
Platelet Transfusion Critical Illness

Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Platelet Transfusion Efficacy in Critically Ill Patients
Actual Study Start Date : May 30, 2018
Estimated Primary Completion Date : December 15, 2019
Estimated Study Completion Date : December 15, 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. platelet transfusion efficacy [ Time Frame: between 18 hours and 28 days after transfusion ]
    corrected count platelet increment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients admitted to intensive care and receiving platelet transfusion whatever the reason for it.
Criteria

Inclusion Criteria:

  • Patients admitted to intensive care and receiving at least one platelet transfusion in intensive care unit

Exclusion Criteria:

  • Age less than 18

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03325140


Contacts
Contact: AUBRON Cécile +33 2 98 34 78 59 cecile.aubron@chu-brest.fr

Locations
France
CHU d'Angers Not yet recruiting
Angers, France, 49100
Contact: Pierre ASFAR, Pr       pierre.asfar@chu-angers.fr   
CHRU de Brest Recruiting
Brest, France, 29609
Contact: Aubron Cécile       cecile.aubron@chu-brest.fr   
Sub-Investigator: Olivier Huet, Pr         
CHU de Nantes Recruiting
Nantes, France, 44093
Contact: LE MEUR Anthony       anthony.lemeur@chu-nantes.fr   
CHU de Rennes Recruiting
Rennes, France, 35033
Contact: SEGUIN Philippe       philippe.seguin@chu-brest.fr   
Sub-Investigator: TADIE Jean-Marc         
CHU de Tours Recruiting
Tours, France, 37044
Contact: EHRMANN Stephan       stephan.ehrmann@chu-tours.fr   
Sponsors and Collaborators
University Hospital, Brest

Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT03325140     History of Changes
Other Study ID Numbers: RE-CCIP (29BRC17.0157)
First Posted: October 30, 2017    Key Record Dates
Last Update Posted: October 10, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes