Clinical trial NCT04879485: Prehospital Transfusion Strategy in Bleeding Patients
Official title: Prehospital Plasma or Red Blood Cell Transfusion Strategy in Major Bleeding; PRIEST Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemorrhage
Blood Component Transfusion
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Norwegian Air Ambulance Foundation
name: Odense University Hospital
name: Copenhagen University Hospital, Denmark
First posted: 2021-05-10
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Major bleeding requiring prehospital transfusion

Exclusion Criteria:

* Transfusion with blood products already initiated

Primary outcomes:
measure: Base deficit
timeFrame: At hospital arrival (with in 1 hour)
Secondary outcomes:
measure: 30 days mortality
timeFrame: mortality within 30 days
measure: Activated Partial Thromboplastin Time (APTT)
timeFrame: At hospital arrival (with in 2 hours)
measure: Endogenous thrombin potential (ETP)
timeFrame: At hospital arrival (with in 2 hours)
measure: International Normalized Ratio (INR)
timeFrame: At hospital arrival (with in 2 hours)
measure: Endothelium markers
timeFrame: At hospital arrival (with in 2 hours)
measure: Endothelium markers
timeFrame: At hospital arrival (with in 2 hours)
measure: In hospital red blood cell transfusion requirements
timeFrame: Within in the first 24 hours after hospital arrival
measure: In hospital plasma transfusion requirements
timeFrame: Within in the first 24 hours after hospital arrival
measure: In hospital platelet transfusion requirements
timeFrame: Within in the first 24 hours after hospital arrival
Other outcomes:
Locations:
city: Silkeborg
country: Denmark
facility: Aarhus Universityhospital
state: Midtjylland
city: Aarhus
country: Denmark
facility: Danish Air Ambulance
Study officials:
affiliation: Aarhus Universityhospital
name: Christian Fenger-Eriksen
role: STUDY_CHAIR
References: