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| Name | Class |
|---|---|
| Norwegian Air Ambulance Foundation | OTHER |
| Odense University Hospital | OTHER |
| Copenhagen University Hospital, Denmark | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard transfusion | No Intervention | Includes standard transfusion with a mixture of red blood cells and plasma | |
| Plasma | Active Comparator | Transfusion with plasma |
|
| Red Blood cells | Active Comparator | Transfusion with red blood cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood products | Biological | Compare two different transfusion strategies against standard transfusion regimen |
|
| Measure | Description | Time Frame |
|---|---|---|
| Base deficit | Arterial-gas analysis upon arrival with parameter base deficit as primary outcome | At hospital arrival (with in 1 hour) |
| Measure | Description | Time Frame |
|---|---|---|
| 30 days mortality | Mortality, follow up in patient records | mortality within 30 days |
| Activated Partial Thromboplastin Time (APTT) | Plasma sample analysed; APTT |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian Fenger-Eriksen | Aarhus Universityhospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus Universityhospital | Silkeborg | Central Jutland | 8600 | Denmark | ||
| Danish Air Ambulance |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38780066 | Derived | 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. |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| At hospital arrival (with in 2 hours) |
| Endogenous thrombin potential (ETP) | Plasma sample analysed; thrombin generation assay | At hospital arrival (with in 2 hours) |
| International Normalized Ratio (INR) | Plasma sample analysed; INR | At hospital arrival (with in 2 hours) |
| Endothelium markers | Plasma sample analysed; Syndecan-1 | At hospital arrival (with in 2 hours) |
| Endothelium markers | Plasma sample analysed; soluble thrombomodulin | At hospital arrival (with in 2 hours) |
| In hospital red blood cell transfusion requirements | Amount of red blood cells transfused as registered in patient electronic records | Within in the first 24 hours after hospital arrival |
| In hospital plasma transfusion requirements | Amount of plasma transfused as registered in patient electronic records | Within in the first 24 hours after hospital arrival |
| In hospital platelet transfusion requirements | Amount of platelet transfused as registered in patient electronic records | Within in the first 24 hours after hospital arrival |
| Aarhus |
| Denmark |