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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03325140
Other study ID # RE-CCIP (29BRC17.0157)
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 30, 2018
Est. completion date December 15, 2019

Study information

Verified date July 2019
Source University Hospital, Brest
Contact AUBRON Cécile
Phone +33 2 98 34 78 59
Email cecile.aubron@chu-brest.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date December 15, 2019
Est. primary completion date December 15, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Age less than 18

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France CHU d'Angers Angers
France CHRU de Brest Brest
France CH des Pays de Morlaix Morlaix
France CHU de Nantes Nantes
France CHU de Rennes Rennes
France CHU de Tours Tours
France Chba Site de Vannes Vannes

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary platelet transfusion efficacy corrected count platelet increment between 18 hours and 28 days after transfusion
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