Prehospital Transfusion Strategy in Bleeding Patients

University of Aarhus120 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Hemorrhage Blood Component Transfusion

Outcomes

Primary Outcomes

Base deficit

Arterial-gas analysis upon arrival with parameter base deficit as primary outcome

Time frame: At hospital arrival (with in 1 hour)

Secondary Outcomes

30 days mortality

Mortality, follow up in patient records

Time frame: mortality within 30 days

Activated Partial Thromboplastin Time (APTT)

Plasma sample analysed; APTT