Status:
COMPLETED
Transfusion-requirements in Septic Shock Trial
Lead Sponsor:
Scandinavian Critical Care Trials Group
Collaborating Sponsors:
Copenhagen Trial Unit, Center for Clinical Intervention Research
Rigshospitalet, Denmark
Conditions:
Septic Shock
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 harm...
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 b...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
1005 Patients enrolled
Trial Details
Trial ID
NCT01485315
Start Date
November 1 2011
End Date
April 1 2014
Last Update
October 3 2014
Active Locations (32)
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1
Ålborg University Hospital
Aalborg, Denmark
2
Aarhus University Hospital, NBG
Aarhus, Denmark
3
Aarhus University Hospital, Skejby
Aarhus, Denmark
4
Bispebjerg Hospital
Copenhagen, Denmark