Transfusion-requirements in Septic Shock Trial

NCT01485315 | Completed Phase 3 DMC

• 1 other identifier: H-3-2011-114
• Study Type: interventional
• Target: 1,005
• Locations: 4 countries
• Sites: 32

Brief Summary

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

Conditions

Septic Shock

Outcome Measures

Primary Outcomes (1)

• Mortality

  All cause 90 day mortality

  90 day

Secondary Outcomes (12)

• Persistent organ failure

  Day 5

• Persistent organ failure

  Day 14

• Persistent organ failure

  Day 28

• Anaphylactic/allergic reactions

  Followed up until ICU discharge; an expected average of one week

• Haemolytic complications after transfusion of RBC

  Followed up until ICU discharge; an expected average of one week

Study Arms (2)

Liberal blood transfusion

ACTIVE COMPARATOR

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

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

Restrictive blood transfusion

ACTIVE COMPARATOR

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

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

Interventions

SAGM (Saline-Adenine-Glucose-Mannitol) blood transfusion BIOLOGICAL

One unit prestorage, leuko-depleted SAGM blood at haemoglobin at 9.0 g/dl (5.6 mM) or less at point-of-care testing

Also known as: Liberal red blood cell (RBC) transfusion

Liberal blood transfusion

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Scandinavian Critical Care Trials Group: lead
• Copenhagen Trial Unit, Center for Clinical Intervention Research: collaborator
• Rigshospitalet, Denmark: collaborator
• University of Copenhagen: collaborator

Study Sites (32)

Ålborg University Hospital

Aalborg, Denmark

Location

Aarhus University Hospital, NBG

Aarhus, Denmark

Location

Aarhus University Hospital, Skejby

Aarhus, Denmark

Location

Bispebjerg Hospital

Copenhagen, Denmark

Location

Glostrup Hospital

Copenhagen, Denmark

Location

Hvidovre Hospital

Copenhagen, Denmark

Location

Rigshospitalet

Copenhagen, Denmark

Location

Gentofte Hospital

Gentofte Municipality, Denmark

Location

Herning Hospital

Herning, Denmark

Location

Hjørring Hospital

Hjørring, Denmark

Location

Holbæk Hospital

Holbæk, Denmark

Location

Horsens Hospital

Horsens, Denmark

Location

Kolding Hospital

Kolding, Denmark

Location

Køge Hospital

Køge, Denmark

Location

Næstved Hospital

Næstved, Denmark

Location

Randers Hospital

Randers, Denmark

Location

Slagelse Hospital

Slagelse, Denmark

Location

Sønderborg Hospital

Sønderborg, Denmark

Location

Vejle Hospital

Vejle, Denmark

Location

Helsinki University Hospital

Helsinki, Finland

Location

Joensuu Hospital

Joensuu, Finland

Location

Tampere University Hospital

Tampere, Finland

Location

Ålesund Hospital

Ålesund, Norway

Location

Haukeland University Hospital

Bergen, Norway

Location

Akershus University Hospital

Oslo, Norway

Location

Stavanger University Hospital

Stavanger, Norway

Location

Halmstad Hospital

Halmstad, Sweden

Location

Helsingborg Hospital

Helsingborg, Sweden

Location

Karolinska Hospital, Huddinge

Stockholm, Sweden

Location

Karolinska Institutet Solna

Stockholm, Sweden

Location

Södersjukhuset

Stockholm, Sweden

Location

Växjö Hospital

Vaxjo, Sweden

Location

Related Publications (4)

• Holst LB, Haase N, Wetterslev J, Wernerman J, Aneman A, Guttormsen AB, Johansson PI, Karlsson S, Klemenzson G, Winding R, Nebrich L, Albeck C, Vang ML, Bulow HH, Elkjaer JM, Nielsen JS, Kirkegaard P, Nibro H, Lindhardt A, Strange D, Thormar K, Poulsen LM, Berezowicz P, Badstolokken PM, Strand K, Cronhjort M, Haunstrup E, Rian O, Oldner A, Bendtsen A, Iversen S, Langva JA, Johansen RB, Nielsen N, Pettila V, Reinikainen M, Keld D, Leivdal S, Breider JM, Tjader I, Reiter N, Gottrup U, White J, Wiis J, Andersen LH, Steensen M, Perner A. Transfusion requirements in septic shock (TRISS) trial - comparing the effects and safety of liberal versus restrictive red blood cell transfusion in septic shock patients in the ICU: protocol for a randomised controlled trial. Trials. 2013 May 23;14:150. doi: 10.1186/1745-6215-14-150.

  PMID: 23702006 BACKGROUND

• Holst LB, Haase N, Wetterslev J, Wernerman J, Guttormsen AB, Karlsson S, Johansson PI, Aneman A, Vang ML, Winding R, Nebrich L, Nibro HL, Rasmussen BS, Lauridsen JR, Nielsen JS, Oldner A, Pettila V, Cronhjort MB, Andersen LH, Pedersen UG, Reiter N, Wiis J, White JO, Russell L, Thornberg KJ, Hjortrup PB, Muller RG, Moller MH, Steensen M, Tjader I, Kilsand K, Odeberg-Wernerman S, Sjobo B, Bundgaard H, Thyo MA, Lodahl D, Maerkedahl R, Albeck C, Illum D, Kruse M, Winkel P, Perner A; TRISS Trial Group; Scandinavian Critical Care Trials Group. Lower versus higher hemoglobin threshold for transfusion in septic shock. N Engl J Med. 2014 Oct 9;371(15):1381-91. doi: 10.1056/NEJMoa1406617. Epub 2014 Oct 1.

  PMID: 25270275 RESULT

• Carson JL, Stanworth SJ, Dennis JA, Fergusson DA, Pagano MB, Roubinian NH, Turgeon AF, Valentine S, Trivella M, Doree C, Hebert PC. Transfusion thresholds and other strategies for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2025 Oct 20;10(10):CD002042. doi: 10.1002/14651858.CD002042.pub6.

  PMID: 41114449 DERIVED

• Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Doree C, Hebert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002042. doi: 10.1002/14651858.CD002042.pub5.

  PMID: 34932836 DERIVED

MeSH Terms

Conditions

Shock, Septic

Interventions

Blood Transfusion; Erythrocyte Count

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics; Blood Cell Count; Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Anders Perner, MD, PhD

  Dept. of Intensive Care, Rigshospitalet / SCCTG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: November 30, 2011
• First Posted: December 5, 2011
• Study Start: November 1, 2011
• Primary Completion: March 1, 2014
• Study Completion: April 1, 2014
• Last Updated: October 3, 2014

Record last verified: 2014-10

Locations

DK (19); FI (3); NO (4); SE (6)