Prehospital Transfusion Strategy in Bleeding Patients

Study Overview
=================
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: 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). 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.

Official Title
-----------------
Prehospital Plasma or Red Blood Cell Transfusion Strategy in Major Bleeding; PRIEST Trial

Conditions
-----------------
Hemorrhage, Blood Component Transfusion

Intervention / Treatment
-----------------
* Biological: Blood products


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Major bleeding requiring prehospital transfusion Exclusion Criteria: Transfusion with blood products already initiated

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard transfusion<br>Includes standard transfusion with a mixture of red blood cells and plasma | |
| Active Comparator: Plasma<br>Transfusion with plasma | Biological: Blood products<br>* Compare two different transfusion strategies against standard transfusion regimen<br>|
| Active Comparator: Red Blood cells<br>Transfusion with red blood cells | Biological: Blood products<br>* Compare two different transfusion strategies against standard transfusion regimen<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |