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Septic ShockPhase 3TRISSNCT01485315

Transfusion-requirements in Septic Shock Trial

A Phase 3 study testing SAGM (Saline-Adenine-Glucose-Mannitol) blood transfusion in people with Septic Shock, run by Scandinavian Critical Care Trials Group at 32 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Septic Shock
What is being tested?
SAGM (Saline-Adenine-Glucose-Mannitol) blood transfusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,005 participants
Where
32 sitesin 4 countries
Study dates
Nov 2011to Apr 2014
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

32 sites in 4 countries.

32 sites in 4 countries

Denmark19 sites

  • Ålborg University Hospital

    Aalborg

  • Aarhus University Hospital, NBG

    Aarhus

  • Aarhus University Hospital, Skejby

    Aarhus

  • Bispebjerg Hospital

    Copenhagen

  • Glostrup Hospital

    Copenhagen

  • Hvidovre Hospital

    Copenhagen

  • Rigshospitalet

    Copenhagen

  • Gentofte Hospital

    Gentofte Municipality

  • Herning Hospital

    Herning

  • Hjørring Hospital

    Hjørring

  • Holbæk Hospital

    Holbæk

  • Horsens Hospital

    Horsens

  • Køge Hospital

    Køge

  • Kolding Hospital

    Kolding

  • Næstved Hospital

    Næstved

  • Randers Hospital

    Randers

  • Slagelse Hospital

    Slagelse

  • Sønderborg Hospital

    Sønderborg

  • Vejle Hospital

    Vejle

Other trials in Denmark

Sweden6 sites

  • Halmstad Hospital

    Halmstad

  • Helsingborg Hospital

    Helsingborg

  • Karolinska Hospital, Huddinge

    Stockholm

  • Karolinska Institutet Solna

    Stockholm

  • Södersjukhuset

    Stockholm

  • Växjö Hospital

    Vaxjo

Other trials in Sweden

Norway4 sites

  • Ålesund Hospital

    Ålesund

  • Haukeland University Hospital

    Bergen

  • Akershus University Hospital

    Oslo

  • Stavanger University Hospital

    Stavanger

Other trials in Norway

Finland3 sites

  • Helsinki University Hospital

    Helsinki

  • Joensuu Hospital

    Joensuu

  • Tampere University Hospital

    Tampere

Other trials in Finland

About this study

Official title: Effects of Red Blood Cell Transfusion on Mortality and Morbidity in Patients With Septic Shock

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

Read the detailed 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

Conditions
Septic Shock
Being tested
SAGM (Saline-Adenine-Glucose-Mannitol) blood transfusion
Medical subject headings
Shock, Septic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SAGM (Saline-Adenine-Glucose-Mannitol) blood transfusionBiological

    Also called Liberal red blood cell (RBC) transfusion

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

  • SAGM (Saline-Adenine-Glucose-Mannitol) blood transfusionBiological

    Also called Restrictive red blood cell (RBC) transfusion

    One unit prestorage, leuko-depleted SAGM blood at haemoglobin 7.0 g/dl (4.3 mM) or less at point-of-care testing

Study groups in NCT01485315
Study groupRoleWhat they receive
Liberal blood transfusionActive comparatorBlood transfusion at haemoglobin 9.0 g/dl (5.6 mM) or less
Receives: Biological: SAGM (Saline-Adenine-Glucose-Mannitol) blood transfusion
Restrictive blood transfusionActive comparatorBlood transfusion at haemoglobin 7.0 g/dl (4.3 mM) or less
Receives: Biological: SAGM (Saline-Adenine-Glucose-Mannitol) blood transfusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mortality

    All cause 90 day mortality

    Measured: 90 day

Secondary outcomes (12)

  1. Persistent organ failure

    Defined as need for ventilation, vasopressor/inotrope infusion or renal replacement therapy

    Measured: Day 5

  2. Persistent organ failure

    Defined as need for ventilation, vasopressor/inotrope infusion or renal replacement therapy

    Measured: Day 14

  3. Persistent organ failure

    Defined as need for ventilation, vasopressor/inotrope infusion or renal replacement therapy

    Measured: Day 28

  4. Anaphylactic/allergic reactions

    Defined by the clinician on the basis of mucocutaneous signs and symptoms (e.g. urticaria, pruritus, localised angio- oedema).

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

  5. Haemolytic complications after transfusion of RBC

    Defined by the clinician on the basis of haemoglobinuria or increased free plasma haemoglobin.

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

  6. Transfusion associated acute lung injury (TRALI)

    TRALI defined as:

    1. Acute or worsening hypoxaemia ((PaO2/FiO2 < 40 (PaO2 in kPa) or <300 (PaO2 in mmHg) regardless of PEEP) OR > 50% relative increase in FiO2.

    AND II. Occurrence within 6 hours after RBC transfusion AND III. Acute or worsening pulmonary infiltrates on frontal chest x-ray OR clinical signs of overt pulmonary oedema

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

  7. Transfusion associated circulatory overload (TACO)

    TACO defined as:

    1. Acute or worsening hypoxaemia ((PaO2/FiO2 < 40 (PaO2 in kPa) or <300 (PaO2 in mmHg) regardless of PEEP) OR > 50% relative increase in FiO2.

    AND II. Occurrence within 6 hours after RBC transfusion AND III. Acute or worsening pulmonary infiltrates on frontal chest x-ray OR clinical signs of overt pulmonary oedema AND IV. Increased blood pressure AND VI. Positive fluid balance

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

  8. Ischaemic events

    Defined as either myocardial, cerebral, intestinal or acute limb ischaemia

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

  9. Days alive without life support

    Life support defined as need for ventilation, vasopressor/inotrope infusion or renal replacement therapy. Days alive without each of these interventions will be reported

    Measured: 90-days

  10. Days alive and out of hospital

    Measured: 90 days

  11. Mortality within the whole observation period

    Mortality within the whole observation period reported at day 28, six-month and 1 year after randomisation of the last patient.

    Measured: One year after randomisation of the last patient

  12. Health-related quality of life

    Physical and mental component summary scores of SF 36

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2011 (estimated)
  2. Study startNov 2011
  3. Primary completionMar 2014
  4. Study completionApr 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,005 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01485315
Sponsor's protocol ID
H-3-2011-114
Acronym
TRISS
Status last verified
Oct 2014
First submitted
30 Nov 2011
Last updated
3 Oct 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 23702006

  • 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.

    PubMed 25270275

  • 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.

    PubMed 41114449

  • 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.

    PubMed 34932836

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SAGM (Saline-Adenine-Glucose-Mannitol) blood transfusion in people with Septic Shock, run by Scandinavian Critical Care Trials Group at 32 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in Denmark, Sweden, Norway, Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mortality (time frame: 90 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01485315, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2014.

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