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NCT Number: NCT04879485

Prehospital Transfusion Strategy in Bleeding Patients

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.

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Key information

Conditions

Hemorrhage Blood Component Transfusion Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus Universityhospital, Silkeborg, Central Jutland, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Major bleeding requiring prehospital transfusion

Exclusion criteria

  • Transfusion with blood products already initiated

Treatment and study plan

Blood products

Biological

Compare two different transfusion strategies against standard transfusion regimen

Primary outcomes

  1. Base deficit

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

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

Secondary outcomes

  1. 30 days mortality

    Time frame: mortality within 30 days

    Mortality, follow up in patient records

  2. Activated Partial Thromboplastin Time (APTT)

    Time frame: At hospital arrival (with in 2 hours)

    Plasma sample analysed; APTT

  3. Endogenous thrombin potential (ETP)

    Time frame: At hospital arrival (with in 2 hours)

    Plasma sample analysed; thrombin generation assay

  4. International Normalized Ratio (INR)

    Time frame: At hospital arrival (with in 2 hours)

    Plasma sample analysed; INR

  5. Endothelium markers

    Time frame: At hospital arrival (with in 2 hours)

    Plasma sample analysed; Syndecan-1

  6. Endothelium markers

    Time frame: At hospital arrival (with in 2 hours)

    Plasma sample analysed; soluble thrombomodulin

  7. In hospital red blood cell transfusion requirements

    Time frame: Within in the first 24 hours after hospital arrival

    Amount of red blood cells transfused as registered in patient electronic records

  8. In hospital plasma transfusion requirements

    Time frame: Within in the first 24 hours after hospital arrival

    Amount of plasma transfused as registered in patient electronic records

  9. In hospital platelet transfusion requirements

    Time frame: Within in the first 24 hours after hospital arrival

    Amount of platelet transfused as registered in patient electronic records

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Copenhagen University Hospital, Denmark
  • Norwegian Air Ambulance Foundation
  • Odense University Hospital

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
May 10, 2021
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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