Blood Component Transfusion, Hemorrhage
Conditions
Brief summary
The aim of study is to compare clinical and biochemical effect of three different transfusion strategies among patients with major hemorrhage requiring prehospital transfusion. 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.
Detailed description
Rationale for the study: 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.
Interventions
BIOLOGICALBlood products
Compare two different transfusion strategies against standard transfusion regimen
Sponsors
Norwegian Air Ambulance Foundation
Odense University Hospital
Copenhagen University Hospital, Denmark
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Major bleeding requiring prehospital transfusion
Exclusion criteria
* Transfusion with blood products already initiated
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Base deficit | At hospital arrival (with in 1 hour) | Arterial-gas analysis upon arrival with parameter base deficit as primary outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Activated Partial Thromboplastin Time (APTT) | At hospital arrival (with in 2 hours) | Plasma sample analysed; APTT |
| Endogenous thrombin potential (ETP) | At hospital arrival (with in 2 hours) | Plasma sample analysed; thrombin generation assay |
| International Normalized Ratio (INR) | At hospital arrival (with in 2 hours) | Plasma sample analysed; INR |
| 30 days mortality | mortality within 30 days | Mortality, follow up in patient records |
| In hospital red blood cell transfusion requirements | Within in the first 24 hours after hospital arrival | Amount of red blood cells transfused as registered in patient electronic records |
| In hospital plasma transfusion requirements | Within in the first 24 hours after hospital arrival | Amount of plasma transfused as registered in patient electronic records |
| In hospital platelet transfusion requirements | Within in the first 24 hours after hospital arrival | Amount of platelet transfused as registered in patient electronic records |
| Endothelium markers | At hospital arrival (with in 2 hours) | Plasma sample analysed; Syndecan-1 |
Countries
Denmark
Outcome results
None listed