CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 100 enrolled
Drug / intervention
Restrictive RBC Transfusion +1 morebiological
Likely dose
Restrictive RBC Transfusion 70 gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00944112
NCT00944112N/ACompleted

A Feasibility Randomized Trial Comparing Restrictive and Liberal Blood Transfusion Strategies in Patients Requiring Four or More Days in Intensive Care

University of Edinburgh·interventional·Posted Jul 23, 2009·Updated Mar 8, 2011

In Brief

A clinical study evaluating Restrictive RBC Transfusion and Liberal RBC Transfusion for Intensive Care and 2 related conditions. Completed, enrolled 100 participants across 6 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 23, 2009
Enrollment StartAug 1, 2009
Primary CompletionNov 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 16.9 years ago

Interventions

Restrictive RBC Transfusionbiological

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.

Liberal RBC Transfusionbiological

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.