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NCT Number: NCT01485315

Transfusion-requirements in Septic Shock Trial

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ålborg University Hospital, Aalborg, Denmark

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Liberal red blood cell (RBC) transfusion

Primary outcomes

  1. Mortality

    Time frame: 90 day

    All cause 90 day mortality

Secondary outcomes

  1. Persistent organ failure

    Time frame: Day 5

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

  2. Persistent organ failure

    Time frame: Day 14

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

  3. Persistent organ failure

    Time frame: Day 28

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

  4. Anaphylactic/allergic reactions

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

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

  5. Haemolytic complications after transfusion of RBC

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

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

  6. Transfusion associated acute lung injury (TRALI)

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

    TRALI defined as:

    I. 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

  7. Transfusion associated circulatory overload (TACO)

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

    TACO defined as:

    I. 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

  8. Ischaemic events

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

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

  9. Days alive without life support

    Time frame: 90-days

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

  10. Days alive and out of hospital

    Time frame: 90 days

  11. Mortality within the whole observation period

    Time frame: One year after randomisation of the last patient

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

  12. Health-related quality of life

    Time frame: 1 year

    Physical and mental component summary scores of SF 36

Sponsors and collaborators

Lead sponsor

Scandinavian Critical Care Trials Group

Other

Collaborators

  • Copenhagen Trial Unit, Center for Clinical Intervention Research
  • Rigshospitalet, Denmark
  • University of Copenhagen

Registry information

Official study title

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

Acronym: TRISS

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Dec 5, 2011
Registry last updated
Oct 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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