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| Name | Class |
|---|---|
| Copenhagen Trial Unit, Center for Clinical Intervention Research | OTHER |
| Rigshospitalet, Denmark | OTHER |
| University of Copenhagen | OTHER |
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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
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liberal blood transfusion | Active Comparator | Blood transfusion at haemoglobin 9.0 g/dl (5.6 mM) or less |
|
| Restrictive blood transfusion | Active Comparator | Blood transfusion at haemoglobin 7.0 g/dl (4.3 mM) or less |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | All cause 90 day mortality | 90 day |
| Measure | Description | Time Frame |
|---|---|---|
| Persistent organ failure | Defined as need for ventilation, vasopressor/inotrope infusion or renal replacement therapy | Day 5 |
| Persistent organ failure | Defined as need for ventilation, vasopressor/inotrope infusion or renal replacement therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anders Perner, MD, PhD | Dept. of Intensive Care, Rigshospitalet / SCCTG | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ålborg University Hospital | Aalborg | Denmark | ||||
| Aarhus University Hospital, NBG |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23702006 | Background | 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. | |
| 25270275 |
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|
| SAGM (Saline-Adenine-Glucose-Mannitol) blood transfusion | Biological | One unit prestorage, leuko-depleted SAGM blood at haemoglobin 7.0 g/dl (4.3 mM) or less at point-of-care testing |
|
|
| Day 14 |
| Persistent organ failure | Defined as need for ventilation, vasopressor/inotrope infusion or renal replacement therapy | Day 28 |
| Anaphylactic/allergic reactions | Defined by the clinician on the basis of mucocutaneous signs and symptoms (e.g. urticaria, pruritus, localised angio- oedema). | Followed up until ICU discharge; an expected average of one week |
| Haemolytic complications after transfusion of RBC | Defined by the clinician on the basis of haemoglobinuria or increased free plasma haemoglobin. | Followed up until ICU discharge; an expected average of one week |
| Transfusion associated acute lung injury (TRALI) | 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 | Followed up until ICU discharge; an expected average of one week |
| Transfusion associated circulatory overload (TACO) | 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 | Followed up until ICU discharge; an expected average of one week |
| Ischaemic events | Defined as either myocardial, cerebral, intestinal or acute limb ischaemia | Followed up until ICU discharge; an expected average of one week |
| 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 | 90-days |
| Days alive and out of hospital | 90 days |
| 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. | One year after randomisation of the last patient |
| Health-related quality of life | Physical and mental component summary scores of SF 36 | 1 year |
| Aarhus |
| Denmark |
| Aarhus University Hospital, Skejby | Aarhus | Denmark |
| Bispebjerg Hospital | Copenhagen | Denmark |
| Glostrup Hospital | Copenhagen | Denmark |
| Hvidovre Hospital | Copenhagen | Denmark |
| Rigshospitalet | Copenhagen | Denmark |
| Gentofte Hospital | Gentofte Municipality | Denmark |
| Herning Hospital | Herning | Denmark |
| Hjørring Hospital | Hjørring | Denmark |
| Holbæk Hospital | Holbæk | Denmark |
| Horsens Hospital | Horsens | Denmark |
| Kolding Hospital | Kolding | Denmark |
| Køge Hospital | Køge | Denmark |
| Næstved Hospital | Næstved | Denmark |
| Randers Hospital | Randers | Denmark |
| Slagelse Hospital | Slagelse | Denmark |
| Sønderborg Hospital | Sønderborg | Denmark |
| Vejle Hospital | Vejle | Denmark |
| Helsinki University Hospital | Helsinki | Finland |
| Joensuu Hospital | Joensuu | Finland |
| Tampere University Hospital | Tampere | Finland |
| Ålesund Hospital | Ålesund | Norway |
| Haukeland University Hospital | Bergen | Norway |
| Akershus University Hospital | Oslo | Norway |
| Stavanger University Hospital | Stavanger | Norway |
| Halmstad Hospital | Halmstad | Sweden |
| Helsingborg Hospital | Helsingborg | Sweden |
| Karolinska Hospital, Huddinge | Stockholm | Sweden |
| Karolinska Institutet Solna | Stockholm | Sweden |
| Södersjukhuset | Stockholm | Sweden |
| Växjö Hospital | Vaxjo | Sweden |
| Result |
| 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. |
| 41114449 | Derived | 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. |
| 34932836 | 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. |
| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
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| ID | Term |
|---|---|
| D001803 | Blood Transfusion |
| D004906 | Erythrocyte Count |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D001772 | Blood Cell Count |
| D002452 | Cell Count |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006403 | Hematologic Tests |
| D008919 | Investigative Techniques |
| D002468 | Cell Physiological Phenomena |
| D001790 | Blood Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
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