Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2021-05-03
2024-12-31
Brief Summary
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A) Present prehospital standard treatment including a mixture of plasma and Red blood cell transfusion (RBC) transfusion B) Red blood cell transfusion (RBC) only C) Plasma transfusion only
Hypothesis:
1. Transfusion strategy including a mixture of RBC and plasma is superior as compared with only plasma or only RBC strategy in terms of initial treatment of circulatory shock (expressed as base deficit).
2. Endothelial function and ability of clot formation is preserved to a greater extent in patients receiving plasma.
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Detailed Description
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The warranted clinical question to be unsolved is whether initial pre-hospital transfusion in bleeding patients should base on a strategy including plasma, RBC or combination of both.
Despite possible benefits, allogenic blood product are associated with side effects and pose significant logistic challenges in the prehospital environment. So far, a majority of the present knowledge is based on retrospective evaluations or clinical trials without relevant control groups.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard transfusion
Includes standard transfusion with a mixture of red blood cells and plasma
No interventions assigned to this group
Plasma
Transfusion with plasma
Blood products
Compare two different transfusion strategies against standard transfusion regimen
Red Blood cells
Transfusion with red blood cells
Blood products
Compare two different transfusion strategies against standard transfusion regimen
Interventions
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Blood products
Compare two different transfusion strategies against standard transfusion regimen
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Norwegian Air Ambulance Foundation
OTHER
Odense University Hospital
OTHER
Copenhagen University Hospital, Denmark
OTHER
University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Christian Fenger-Eriksen
Role: STUDY_CHAIR
Aarhus Universityhospital
Locations
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Aarhus Universityhospital
Silkeborg, Central Jutland, Denmark
Danish Air Ambulance
Aarhus, , Denmark
Countries
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References
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Radford M, Estcourt LJ, Sirotich E, Pitre T, Britto J, Watson M, Brunskill SJ, Fergusson DA, Doree C, Arnold DM. Restrictive versus liberal red blood cell transfusion strategies for people with haematological malignancies treated with intensive chemotherapy or radiotherapy, or both, with or without haematopoietic stem cell support. Cochrane Database Syst Rev. 2024 May 23;5(5):CD011305. doi: 10.1002/14651858.CD011305.pub3.
Other Identifiers
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1-10-72-289-20
Identifier Type: -
Identifier Source: org_study_id
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