Platelet Transfusions in Critically Ill Patient

NCT03325140 | Unknown DMC

• 1 other identifier: RE-CCIP (29BRC17.0157)
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 7

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.

Conditions

Platelet Transfusion; Critical Illness

Outcome Measures

Primary Outcomes (1)

• platelet transfusion efficacy

  corrected count platelet increment

  between 18 hours and 28 days after transfusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to intensive care and receiving platelet transfusion whatever the reason for it.

You may qualify if:

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

You may not qualify if:

• Age less than 18

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (7)

CHU d'Angers

Angers, 49100, France

RECRUITING

CHRU de Brest

Brest, 29609, France

RECRUITING

CH des Pays de Morlaix

Morlaix, 29 672, France

RECRUITING

CHU de Nantes

Nantes, 44093, France

RECRUITING

CHU de Rennes

Rennes, 35033, France

RECRUITING

CHU de Tours

Tours, 37044, France

RECRUITING

Chba Site de Vannes

Vannes, 56 017, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 37759268 DERIVED

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

AUBRON Cécile

CONTACT

+33 2 98 34 78 59; cecile.aubron@chu-brest.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2017
• First Posted: October 30, 2017
• Study Start: May 30, 2018
• Primary Completion: December 15, 2019
• Study Completion: December 15, 2019
• Last Updated: July 18, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available after the publication of result and ending three years maximum following the last visit of the last patient
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. requestors will be required to sign and complete a data access agreement

Locations

FR (7)