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Trial record 1 of 1 for:    NCT01485315
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Transfusion-requirements in Septic Shock Trial (TRISS)

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ClinicalTrials.gov Identifier: NCT01485315
Recruitment Status : Completed
First Posted : December 5, 2011
Last Update Posted : October 3, 2014
Sponsor:
Collaborators:
Copenhagen Trial Unit, Center for Clinical Intervention Research
Rigshospitalet, Denmark
University of Copenhagen
Information provided by (Responsible Party):
Anders Perner, Scandinavian Critical Care Trials Group

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

Condition or disease Intervention/treatment Phase
Septic Shock Biological: SAGM (Saline-Adenine-Glucose-Mannitol) blood transfusion Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1005 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Red Blood Cell Transfusion on Mortality and Morbidity in Patients With Septic Shock
Study Start Date : November 2011
Actual Primary Completion Date : March 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Liberal blood transfusion
Blood transfusion at haemoglobin 9.0 g/dl (5.6 mM) or less
Biological: SAGM (Saline-Adenine-Glucose-Mannitol) blood 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
Other Name: Liberal red blood cell (RBC) transfusion

Active Comparator: Restrictive blood transfusion
Blood transfusion at haemoglobin 7.0 g/dl (4.3 mM) or less
Biological: SAGM (Saline-Adenine-Glucose-Mannitol) blood transfusion
One unit prestorage, leuko-depleted SAGM blood at haemoglobin 7.0 g/dl (4.3 mM) or less at point-of-care testing
Other Name: Restrictive red blood cell (RBC) transfusion




Primary Outcome Measures :
  1. Mortality [ Time Frame: 90 day ]
    All cause 90 day mortality


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01485315


Locations
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Sponsors and Collaborators
Scandinavian Critical Care Trials Group
Copenhagen Trial Unit, Center for Clinical Intervention Research
Rigshospitalet, Denmark
University of Copenhagen
Investigators
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Principal Investigator: Anders Perner, MD, PhD Dept. of Intensive Care, Rigshospitalet / SCCTG
Publications of Results:
Other Publications:
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Responsible Party: Anders Perner, Principle Investigator, Scandinavian Critical Care Trials Group
ClinicalTrials.gov Identifier: NCT01485315    
Other Study ID Numbers: H-3-2011-114
First Posted: December 5, 2011    Key Record Dates
Last Update Posted: October 3, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Shock, Septic
Shock
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Mannitol
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Physiological Effects of Drugs