Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Feasibility Randomized Trial Comparing Restrictive and Liberal Blood Transfusion Strategies in Patients Requiring Four or More Days in Intensive Care
Brief 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.


Options:
A: Arm Label: Restrictive Red blood cell Transfusion; Type: EXPERIMENTAL; Interventions: Other: Red blood cell Transfusion | Arm Label: Liberal Red blood Cell Transfusion; Type: ACTIVE_COMPARATOR; Interventions: Other: Red blood cell Transfusion | Intervention Type: OTHER; Name: Red blood cell Transfusion; Assigned to Arm(s): Liberal Red blood Cell Transfusion, Restrictive Red blood cell Transfusion
B: Arm Label: Allowed drop in hemoglobin to 4.5-5.5 mmol/L; Type: ACTIVE_COMPARATOR; Interventions: Other: Allowed drop in hemoglobin to 4.5-5.5 mmol/L | Arm Label: Allowed drop in hemoglobin to 5.6-6.5 mmol/L; Type: EXPERIMENTAL; Interventions: Other: Allowed drop in hemoglobin to level between 5.6-6.5 mmol/L | Intervention Type: OTHER; Name: Allowed drop in hemoglobin to 4.5-5.5 mmol/L; Assigned to Arm(s): Allowed drop in hemoglobin to 4.5-5.5 mmol/L | Intervention Type: OTHER; Name: Allowed drop in hemoglobin to level between 5.6-6.5 mmol/L; Assigned to Arm(s): Allowed drop in hemoglobin to 5.6-6.5 mmol/L
C: Intervention Type: DRUG; Name: Red blood cell transfusion; Assigned to Arm(s): N/A
D: Arm Label: Restrictive RBC Transfusion Group; Type: EXPERIMENTAL; Interventions: Biological: Restrictive RBC Transfusion | Arm Label: Liberal RBC Transfusion Group; Type: EXPERIMENTAL; Interventions: Biological: Liberal RBC Transfusion | Intervention Type: BIOLOGICAL; Name: Restrictive RBC Transfusion; Assigned to Arm(s): Restrictive RBC Transfusion Group | Intervention Type: BIOLOGICAL; Name: Liberal RBC Transfusion; Assigned to Arm(s): Liberal RBC Transfusion Group

Answer: D