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Prehospital Transfusion Strategy in Bleeding Patients

Primary Purpose

Hemorrhage, Blood Component Transfusion

Status

Recruiting

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Blood products

About this trial

This is an interventional treatment trial for Hemorrhage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Major bleeding requiring prehospital transfusion

Exclusion Criteria:

Transfusion with blood products already initiated

Sites / Locations

Aarhus Universityhospital
Danish Air AmbulanceRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Arm Label

Standard transfusion

Plasma

Red Blood cells

Arm Description

Includes standard transfusion with a mixture of red blood cells and plasma

Transfusion with plasma

Transfusion with red blood cells

Outcomes

Primary Outcome Measures

Base deficit

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

Secondary Outcome Measures

30 days mortality

Mortality, follow up in patient records

Activated Partial Thromboplastin Time (APTT)

Plasma sample analysed; APTT

Endogenous thrombin potential (ETP)

Plasma sample analysed; thrombin generation assay

International Normalized Ratio (INR)

Plasma sample analysed; INR

Endothelium markers

Plasma sample analysed; Syndecan-1

Endothelium markers

Plasma sample analysed; soluble thrombomodulin

In hospital red blood cell transfusion requirements

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

In hospital plasma transfusion requirements

Amount of plasma transfused as registered in patient electronic records

In hospital platelet transfusion requirements

Amount of platelet transfused as registered in patient electronic records

Full Information

NCT ID

NCT04879485

First Posted

April 29, 2021

Last Updated

October 5, 2021

Sponsor

University of Aarhus

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04879485

Brief Title

Prehospital Transfusion Strategy in Bleeding Patients

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Recruiting

Study Start Date

May 3, 2021 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Aarhus

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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. 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: 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hemorrhage, Blood Component Transfusion

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Standard transfusion

Arm Type

No Intervention

Arm Description

Includes standard transfusion with a mixture of red blood cells and plasma

Arm Title

Plasma

Arm Type

Active Comparator

Arm Description

Transfusion with plasma

Arm Title

Red Blood cells

Arm Type

Active Comparator

Arm Description

Transfusion with red blood cells

Intervention Type

Biological

Intervention Name(s)

Blood products

Intervention Description

Compare two different transfusion strategies against standard transfusion regimen

Primary Outcome Measure Information:

Title

Base deficit

Description

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

Time Frame

At hospital arrival (with in 1 hour)

Secondary Outcome Measure Information:

Title

30 days mortality

Description

Mortality, follow up in patient records

Time Frame

mortality within 30 days

Title

Activated Partial Thromboplastin Time (APTT)

Description

Plasma sample analysed; APTT

Time Frame