Restrictive and Liberal Transfusion Strategies in Intensive Care

Summary

The most effective transfusion practice in critically ill ICU patients is unknown. Currently the data is unclear as to whether a liberal or restrictive transfusion policy is of most benefit to patients in the short and longer term. The aim of this study is to test the hypothesis that liberal use of RBCs (Hb transfusion trigger ≤90g/L; target Hb range 91-110 g/L) to correct anaemia improves clinical outcomes compared with a restrictive transfusion trigger (Hb transfusion trigger ≤70 g/L; target Hb range 71-90 g/L) in anaemic critically ill patients requiring prolonged ICU stay (≥4 days).

Patients will be randomised to one of two transfusion strategies on a 1:1 basis

Group 1 "Restrictive RBC Transfusion group":

Patients will receive single unit RBC transfusions with a transfusion trigger of ≤70 g/L with a target Hb concentration of 71-90 g/L during the intervention period.

Group 2 "Liberal RBC transfusion group":

Patients will receive single unit RBC transfusions with a transfusion trigger of ≤90 g/L with a target of 91-110 g/L during intervention. These patients will all receive a transfusion on the day of randomisation.

Duration of Intervention:

Remainder of ICU stay or 14 days from randomisation, whichever is longer

Follow-Up

Quality of Life, mobility and health service usage questionnaires at 60 and 180 days.

This is a feasibility study that will provide essential data to ensure the success of the full trial. A qualitative study will also be carried out to explore potential reasons for non-recruitment and clinician concerns with the existing protocol. An exploratory biomarker sub-study will test whether a pro-inflammatory signal occurs in the liberally transfused group associated with transfusions.

Conditions

• Intensive Care
• Blood Transfusion
• Anemia

Interventions

BIOLOGICAL

Restrictive RBC Transfusion

Patients will receive single unit RBC transfusions with a transfusion trigger of ≤70 g/L with a target Hb concentration of 71-90 g/L during the intervention period.

BIOLOGICAL

Liberal RBC Transfusion

Patients will receive single unit RBC transfusions with a transfusion trigger of ≤90 g/L with a target Hb concentration of 91-110 g/L during intervention.

Sponsors & Collaborators

• NHS Lothian

  collaborator OTHER_GOV

• Chief Scientist Office of the Scottish Government

  collaborator OTHER_GOV

• Transfusion Medicine Education and Research Foundation

  collaborator UNKNOWN

• University of Edinburgh

  lead OTHER

Principal Investigators

• Timothy S Walsh, MBChB MD MSc · NHS Lothian

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

55 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-08-31

Primary Completion

2010-11-30

Completion

2010-11-30

Countries

• United Kingdom

Study Locations