Prehospital Transfusion Strategy in Bleeding Patients

Sponsor

University of Aarhus (Other)

Overall Status

Recruiting

CT.gov ID

NCT04879485

Collaborator

Norwegian Air Ambulance Foundation (Other), Odense University Hospital (Other), Copenhagen University Hospital, Denmark (Other)

120

Enrollment

Locations

Arms

37.9

Anticipated Duration (Months)

Patients Per Site

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

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:

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).
Endothelial function and ability of clot formation is preserved to a greater extent in patients receiving plasma.

Condition or Disease	Intervention/Treatment	Phase
Hemorrhage Blood Component Transfusion	Biological: Blood products	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 3, 2021

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Jun 30, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Base deficit [At hospital arrival (with in 1 hour)]
Arterial-gas analysis upon arrival with parameter base deficit as primary outcome

Secondary Outcome Measures

30 days mortality [mortality within 30 days]
Mortality, follow up in patient records
Activated Partial Thromboplastin Time (APTT) [At hospital arrival (with in 2 hours)]
Plasma sample analysed; APTT
Endogenous thrombin potential (ETP) [At hospital arrival (with in 2 hours)]
Plasma sample analysed; thrombin generation assay
International Normalized Ratio (INR) [At hospital arrival (with in 2 hours)]
Plasma sample analysed; INR
Endothelium markers [At hospital arrival (with in 2 hours)]
Plasma sample analysed; Syndecan-1
Endothelium markers [At hospital arrival (with in 2 hours)]
Plasma sample analysed; soluble thrombomodulin
In hospital red blood cell transfusion requirements [Within in the first 24 hours after hospital arrival]
Amount of red blood cells transfused as registered in patient electronic records
In hospital plasma transfusion requirements [Within in the first 24 hours after hospital arrival]
Amount of plasma transfused as registered in patient electronic records
In hospital platelet transfusion requirements [Within in the first 24 hours after hospital arrival]
Amount of platelet transfused as registered in patient electronic records

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Major bleeding requiring prehospital transfusion

Exclusion Criteria:

Transfusion with blood products already initiated

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aarhus Universityhospital	Silkeborg	Midtjylland	Denmark	8600
2	Danish Air Ambulance	Aarhus		Denmark

Sponsors and Collaborators

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

Investigators

Study Chair: Christian Fenger-Eriksen, Aarhus Universityhospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Aarhus

ClinicalTrials.gov Identifier:

NCT04879485

Other Study ID Numbers:

1-10-72-289-20

First Posted:

May 10, 2021

Last Update Posted:

Oct 6, 2021

Last Verified:

May 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hemorrhage

Study Results

No Results Posted as of Oct 6, 2021