Trial record 4 of 208 for: Open Studies | blood transfusion

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Transfusion-requirements in Septic Shock Trial (TRISS)

This study is currently recruiting participants.

Verified May 2013 by Scandinavian Critical Care Trials Group

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

ClinicalTrials.gov Identifier:

NCT01485315

First received: November 30, 2011

Last updated: May 15, 2013

Last verified: May 2013

History of Changes

Purpose

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	Intervention	Phase
Septic Shock	Biological: SAGM (Saline-Adenine-Glucose-Mannitol) blood transfusion	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Effects of Red Blood Cell Transfusion on Mortality and Morbidity in Patients With Septic Shock

Resource links provided by NLM:

MedlinePlus related topics: Blood Transfusion and Donation Sepsis Shock

Drug Information available for: Mannitol Adenine Dextrose

U.S. FDA Resources

Further study details as provided by Scandinavian Critical Care Trials Group:

Primary Outcome Measures:

Mortality [ Time Frame: 90 day ] [ Designated as safety issue: No ]
All cause 90 day mortality

Secondary Outcome Measures:

Persistent organ failure [ Time Frame: Day 5 ] [ Designated as safety issue: No ]
Defined as need for ventilation, vasopressor/inotrope infusion or renal replacement therapy
Persistent organ failure [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
Defined as need for ventilation, vasopressor/inotrope infusion or renal replacement therapy
Persistent organ failure [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
Defined as need for ventilation, vasopressor/inotrope infusion or renal replacement therapy
Anaphylactic/allergic reactions [ Time Frame: Followed up until ICU discharge; an expected average of one week ] [ Designated as safety issue: Yes ]
Defined by the clinician on the basis of mucocutaneous signs and symptoms (e.g. urticaria, pruritus, localised angio- oedema).
Haemolytic complications after transfusion of RBC [ Time Frame: Followed up until ICU discharge; an expected average of one week ] [ Designated as safety issue: Yes ]
Defined by the clinician on the basis of haemoglobinuria or increased free plasma haemoglobin.
Transfusion associated acute lung injury (TRALI) [ Time Frame: Followed up until ICU discharge; an expected average of one week ] [ Designated as safety issue: Yes ]
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
Transfusion associated circulatory overload (TACO) [ Time Frame: Followed up until ICU discharge; an expected average of one week ] [ Designated as safety issue: Yes ]
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
Ischaemic events [ Time Frame: Followed up until ICU discharge; an expected average of one week ] [ Designated as safety issue: Yes ]
Defined as either myocardial, cerebral, intestinal or acute limb ischaemia
Length of stay in ICU [ Time Frame: Followed up until ICU discharge; an expected average of one week ] [ Designated as safety issue: No ]
Days in need of life support among survivors [ Time Frame: Followed up until ICU discharge; an expected average of one week ] [ Designated as safety issue: No ]
Life support defined as need for ventilation, vasopressor/inotrope infusion or renal replacement therapy
Length of stay in hospital [ Time Frame: Followed up until hospital discharge; an expected average of 3 weeks ] [ Designated as safety issue: No ]
Mortality within the whole observation period [ Time Frame: One year after randomisation of the last patient ] [ Designated as safety issue: No ]
Mortality within the whole observation period reported at day 28, six-month and 1 year after randomisation of the last patient.
Health-related quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Physical and mental component summary scores of SF 36

Estimated Enrollment:	1000
Study Start Date:	November 2011
Estimated Study Completion Date:	March 2014
Estimated Primary Completion Date:	January 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01485315

Contacts

Contact: Lars B Holst, MD	+45 3545 0552	lars.broksoe.holst@rh.regionh.dk
Contact: Anders Perner, MD, PhD	+45 3545 8333	anders.perner@rh.regionh.dk

Locations

Denmark
Aarhus University Hospital, Skejby	Recruiting
Aarhus, Denmark
Contact: Dorte Keld, MD
Principal Investigator: Dorte Keld, MD
Sub-Investigator: Hanne Ravn, MD, DMSc
Aarhus University Hospital, NBG	Recruiting
Aarhus, Denmark
Contact: Helle Nibro, MD
Contact: Else Tønnesen, MD, DMSc
Principal Investigator: Helle Nibro, MD
Sub-Investigator: Kim M Larsen, MD
Sub-Investigator: Stig E Dyrskov, MD
Glostrup Hospital	Recruiting
Copenhagen, Denmark
Contact: Asger Bendtsen, MD, MPH
Principal Investigator: Asger Bendtsen, MD, MPH
Bispebjerg Hospital	Recruiting
Copenhagen, Denmark
Contact: Anne Lindhardt, MD
Contact: Mojgan Vazin, MD
Principal Investigator: Anne Lindhardt, MD
Sub-Investigator: Katrin Thormar, MD
Sub-Investigator: Ditte Strange, MD
Hvidovre Hospital	Recruiting
Copenhagen, Denmark
Contact: Morten Steensen, MD
Principal Investigator: Lars Nebrich, MD
Sub-Investigator: Carsen Albeck, MD
Sub-Investigator: Morten H Møller, MD, PhD
Rigshospitalet	Recruiting
Copenhagen, Denmark
Contact: Lars B Holst, MD +45 3545 0552 lars.broksoe.holst@rh.regionh.dk
Contact: Nicolai R Haase, MD +45 3545 8415 nicolai.haase@rh.regionh.dk
Principal Investigator: Lars B Holst, MD
Sub-Investigator: Nicolai R Haase, MD
Sub-Investigator: Anders Perner
Sub-Investigator: Jonathan White, MD
Sub-Investigator: Lasse H Andersen, MD
Sub-Investigator: Jørgen Wiis, MD
Sub-Investigator: Morten Steensen, MD
Gentofte Hospital	Recruiting
Gentofte, Denmark
Contact: Nikoloz Mtchedlishvili, MD
Sub-Investigator: Per M Bådstøløkke, MD
Principal Investigator: Nikoloz Mtchedlishvili, MD
Herning Hospital	Recruiting
Herning, Denmark
Contact: Robert Winding, MD
Principal Investigator: Robert Winding, MD
Sub-Investigator: Daniel Lodahl, MD
Sub-Investigator: Piotr Kolodzeike, MD
Sub-Investigator: Lars Vestergaard, MD
Hjørring Hospital	Recruiting
Hjørring, Denmark
Contact: Mary Kruse, MD
Principal Investigator: Mary Kruse, MD
Holbæk Hospital	Recruiting
Holbæk, Denmark
Contact: Hans-Henrik Bülow, MD
Principal Investigator: Hans-Henrik Bülow, MD
Sub-Investigator: Jeanie M Elkjær, MD
Horsens Hospital	Recruiting
Horsens, Denmark
Contact: Elsebeth Haunstrup, MD
Contact: Omar Rian, MD
Principal Investigator: Elsebeth Haunstrup, MD
Sub-Investigator: Omar Rian, MD
Kolding Hospital	Recruiting
Kolding, Denmark
Contact: Jane S Nielsen, MD
Principal Investigator: Jane S Nielsen, MD
Køge Hospital	Recruiting
Køge, Denmark
Contact: Lone M Poulsen, MD
Principal Investigator: Lone M Poulsen, MD
Næstved Hospital	Recruiting
Næstved, Denmark
Contact: Peter Kirkegaard, MD
Contact: Bente K Kristensen, RN
Principal Investigator: Peter Kirkegaard, MD
Randers Hospital	Recruiting
Randers, Denmark
Contact: Marianne L Vang, MD
Principal Investigator: Marianne L Vang, MD
Sub-Investigator: Thorbjørn Grøfte, MD
Sub-Investigator: David F Jensen, MD
Sub-Investigator: Maria A Thyø, MD
Slagelse Hospital	Recruiting
Slagelse, Denmark
Contact: Susanne Iversen, MD
Principal Investigator: Susanne Iversen, MD
Sønderborg Hospital	Recruiting
Sønderborg, Denmark
Contact: Siv Leivdal, MD
Principal Investigator: Siv Leivdal, MD
Vejle Hospital	Recruiting
Vejle, Denmark
Contact: Pawel Berezowicz, MD
Principal Investigator: Pawel Berezowicz, MD, PhD
Ålborg University Hospital	Recruiting
Ålborg, Denmark
Contact: Bodil Rasmussen, MD, PhD
Principal Investigator: Bodil Rasmussen, MD, PhD
Sub-Investigator: Simon Granum, RN
Finland
Helsinki University Hospital	Recruiting
Helsinki, Finland
Contact: Ville Pëttila, MD, PhD
Contact: Leena Pëttila, RN
Principal Investigator: Ville Pëttila, MD, PhD
Joensuu Hospital	Recruiting
Joensuu, Finland
Contact: Matti Reinikainen, MD, PhD
Principal Investigator: Maati Reinikainen, MD, PhD
Tampere University Hospital	Recruiting
Tampere, Finland
Contact: Sari Karlsson, MD, PhD
Contact: Atte Kukkurainen, RN
Principal Investigator: Sari Karlsson, MD, PhD
Norway
Haukeland University Hospital	Recruiting
Bergen, Norway
Contact: Anne B Guttormsen, MD, PhD
Principal Investigator: Anne B Guttormsen, MD, PhD
Akershus University Hospital	Recruiting
Oslo, Norway
Contact: Per M Bådstøløkken, MD
Principal Investigator: Per M Bådstøløkken, MD
Stavanger University Hospital	Recruiting
Stavanger, Norway
Contact: Kristian Strand, MD, PhD
Principal Investigator: Kristian Strand, MD, PhD
Ålesund Hospital	Recruiting
Ålesund, Norway
Contact: Jørn-Åge Longva, MD
Principal Investigator: Jørn-Åge Longva, MD
Sweden
Halmstad Hospital	Recruiting
Halmstad, Sweden
Contact: Michelle Chew, MD, PhD
Principal Investigator: Michelle Chew, MD, PhD
Helsingborg Hospital	Recruiting
Helsingborg, Sweden
Contact: Niklas Nielsen, MD, PhD
Principal Investigator: Niklas Nielsen, MD, PhD
Karolinska Institutet Solna	Recruiting
Stockholm, Sweden
Contact: Anders Oldner, MD, PhD
Contact: David Konrad, MD, PhD
Principal Investigator: Anders Oldner, MD, PhD
Sub-Investigator: Ola Friman, RN
Södersjukhuset	Recruiting
Stockholm, Sweden
Contact: Maria Cronhjort, MD
Principal Investigator: Maria Cronhjort, MD
Karolinska Hospital, Huddinge	Recruiting
Stockholm, Sweden
Contact: Jan Wernerman, MD, PhD
Contact: Kristina Kilsand, RN
Principal Investigator: Jan Wernerman, MD, PhD
Växjö Hospital	Recruiting
Växjö, Sweden
Contact: Jan-Michael Breider, MD
Principal Investigator: Jan-Michael Breider, MD

Sponsors and Collaborators

Scandinavian Critical Care Trials Group

Copenhagen Trial Unit, Center for Clinical Intervention Research

Rigshospitalet, Denmark

University of Copenhagen

Investigators

Principal Investigator:

Anders Perner, MD, PhD

Dept. of Intensive Care, Rigshospitalet / SCCTG

More Information

No publications provided

Responsible Party:	Anders Perner, Principle Investigator, Scandinavian Critical Care Trials Group
ClinicalTrials.gov Identifier:	NCT01485315 History of Changes
Other Study ID Numbers:	H-3-2011-114
Study First Received:	November 30, 2011
Last Updated:	May 15, 2013
Health Authority:	Denmark: The Regional Committee on Biomedical Research Ethics Denmark: Danish Dataprotection Agency Norway: Regional Ethics Commitee Sweden: Regional Ethical Review Board Finland: Ethics Committee

Additional relevant MeSH terms:

Shock
Shock, Septic
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Mannitol

Diuretics, Osmotic
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013

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