Transfusion-requirements in Septic Shock Trial (TRISS)

Scandinavian Critical Care Trials Group

Status and phase: Completed; Phase 3

Conditions: Septic Shock

Treatments: Biological: SAGM (Saline-Adenine-Glucose-Mannitol) blood transfusion

Study type: Interventional

Funder types: Other

Identifiers

NCT01485315

H-3-2011-114

Details and patient eligibility

About

Patients with blood poisoning - sepsis - often receive blood transfusions in the intensive care unit. The evidence that blood transfusion leads to improved outcome is limited and the blood may be harmful to some of these patients. To bridge the gap between clinical practice and evidence, a large randomised clinical trial is needed to document the efficacy and safety of RBC transfusion in these very sick patients

Full description

Background Septic patients often receive red blood cell (RBC) transfusions in the intensive care unit. The evidence that RBC transfusion leads to improved outcome is limited and the intervention may be harmful to some of these patients. In contrast, current guidelines recommend restrictive transfusion of RBC for critical ill patients without septic shock. To bridge the gap between clinical practice and evidence, a large randomised clinical trial is needed to document the efficacy and safety of RBC transfusion in patients with septic shock

Design Pragmatic, multicenter, randomised, outcome assessment-blinded trial of patients with septic shock to RBC transfusion at haemoglobin (Hb) transfusion trigger of 7 g/dl (4.4 mM) or 9 g/dl (5.6 mM), stratified by the presence of haematological malignancy and centre.

Inclusion and exclusion criteria:

To increase the validity of the trial inclusion criteria will be broad with few exclusions

Outcome measures The outcome measures will mainly be patient-important but ICU- and hospital length of stay will also be assessed

Trial size 2 x 500 patients will be needed to show a 9% absolute risk difference in 90-day mortality (baseline mortality of 45%, relative risk reduction 20% (from septic patients in the TRICC trial), alpha of 0.05 (two-sided) and a beta of 0.20 that is a power of 80% (1-beta).

An interim-analysis will be performed after 500 patients. The Data Safety and Monitoring Board (DMSC) will recommend that the trial is stopped if a group-difference in 90-day mortality with p<0.001.

Time Line The first patient is expected to be randomised December 1st 2011 and the trial database is expected to be closed early 2014. The main manuscript will be submitted shortly thereafter.

Funding The trial is publicly funded by the Danish Strategic Research Council

Enrollment: 1,005 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient in the ICU AND
• Fulfil the criteria for septic shock AND
• Have haemoglobin of 9.0 g/dl (5.6 mM) or less AND
• Consent obtainable from patient or proxy or national law allows delayed consent

Exclusion criteria

• Documented wish against transfusion OR
• Previous serious adverse reaction with blood product OR
• Acute coronary syndrome OR
• Life-threatening bleeding OR
• RBC transfusion during current ICU admission OR
• Withdrawal from active therapy or brain death OR
• Lack of informed consent (depending on national law) OR
• Acute burn injury regardless of degree and burn surface area

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,005 participants in 2 patient groups

Liberal blood transfusion

Active Comparator group

Description:

Blood transfusion at haemoglobin 9.0 g/dl (5.6 mM) or less

Treatment:

Biological: SAGM (Saline-Adenine-Glucose-Mannitol) blood transfusion

Biological: SAGM (Saline-Adenine-Glucose-Mannitol) blood transfusion

Restrictive blood transfusion

Active Comparator group

Description:

Blood transfusion at haemoglobin 7.0 g/dl (4.3 mM) or less

Treatment:

Biological: SAGM (Saline-Adenine-Glucose-Mannitol) blood transfusion

Biological: SAGM (Saline-Adenine-Glucose-Mannitol) blood transfusion