Prehospital Transfusion Strategy in Bleeding Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Hemorrhage; Blood Component Transfusion
• Intervention / Treatment: Biological: Blood products

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark
    • Danish Air Ambulance
  • Central Jutland
    • Silkeborg, Central Jutland, Denmark, 8600
      • Aarhus Universityhospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Major bleeding requiring prehospital transfusion

Exclusion Criteria:

• Transfusion with blood products already initiated

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Odense University Hospital; Norwegian Air Ambulance Foundation; Copenhagen University Hospital, Denmark
• Investigators: Study Chair: Christian Fenger-Eriksen, Aarhus Universityhospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2021
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: April 29, 2021
• First Submitted That Met QC Criteria: May 7, 2021
• First Posted (Actual): May 10, 2021

Study Record Updates

• Last Update Posted (Estimated): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hemorrhage
• Other Study ID Numbers: 1-10-72-289-20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No