Prehospital Transfusion Strategy in Bleeding Patients

Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04879485
• Other study ID #: 1-10-72-289-20
• Status: Recruiting
• Phase: N/A
• Start date: May 3, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2021
• Source: University of Aarhus
• Contact: Christian Fenger-Eriksen, PhD
• Phone: +45 7846 6912
• Email: christian.fenger-eriksen[@]viborg.rm.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Major bleeding requiring prehospital transfusion

Exclusion Criteria:

• Transfusion with blood products already initiated

Related Conditions & MeSH terms

• Blood Component Transfusion
• Hemorrhage

Intervention

Biological:
• Blood products
Compare two different transfusion strategies against standard transfusion regimen

Locations

Country	Name	City	State
Denmark	Danish Air Ambulance	Aarhus
Denmark	Aarhus Universityhospital	Silkeborg	Midtjylland

Sponsors (4)

Lead Sponsor	Collaborator
University of Aarhus	Copenhagen University Hospital, Denmark, Norwegian Air Ambulance Foundation, Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Base deficit	Arterial-gas analysis upon arrival with parameter base deficit as primary outcome	At hospital arrival (with in 1 hour)
Secondary	30 days mortality	Mortality, follow up in patient records	mortality within 30 days
Secondary	Activated Partial Thromboplastin Time (APTT)	Plasma sample analysed; APTT	At hospital arrival (with in 2 hours)
Secondary	Endogenous thrombin potential (ETP)	Plasma sample analysed; thrombin generation assay	At hospital arrival (with in 2 hours)
Secondary	International Normalized Ratio (INR)	Plasma sample analysed; INR	At hospital arrival (with in 2 hours)
Secondary	Endothelium markers	Plasma sample analysed; Syndecan-1	At hospital arrival (with in 2 hours)
Secondary	Endothelium markers	Plasma sample analysed; soluble thrombomodulin	At hospital arrival (with in 2 hours)
Secondary	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
Secondary	In hospital plasma transfusion requirements	Amount of plasma transfused as registered in patient electronic records	Within in the first 24 hours after hospital arrival
Secondary	In hospital platelet transfusion requirements	Amount of platelet transfused as registered in patient electronic records	Within in the first 24 hours after hospital arrival