Prehospital Transfusion Strategy in Bleeding Patients

NCT ID: NCT04879485

Last Updated: 2025-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-03

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hemorrhage Blood Component Transfusion

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Standard transfusion

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Plasma

Transfusion with plasma

Group Type ACTIVE_COMPARATOR

Blood products

Intervention Type BIOLOGICAL

Compare two different transfusion strategies against standard transfusion regimen

Red Blood cells

Transfusion with red blood cells

Group Type ACTIVE_COMPARATOR

Blood products

Intervention Type BIOLOGICAL

Compare two different transfusion strategies against standard transfusion regimen

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Blood products

Compare two different transfusion strategies against standard transfusion regimen

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Major bleeding requiring prehospital transfusion

Exclusion Criteria

* Transfusion with blood products already initiated
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Norwegian Air Ambulance Foundation

OTHER

Sponsor Role collaborator

Odense University Hospital

OTHER

Sponsor Role collaborator

Copenhagen University Hospital, Denmark

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Christian Fenger-Eriksen

Role: STUDY_CHAIR

Aarhus Universityhospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Aarhus Universityhospital

Silkeborg, Central Jutland, Denmark

Site Status

Danish Air Ambulance

Aarhus, , Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 38780066 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1-10-72-289-20

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Pre-Hospital Use of Plasma for Traumatic Hemorrhage
NCT02303964 WITHDRAWN PHASE2/PHASE3
Finnish Prehospital Whole Blood Study
NCT05744583 RECRUITING NA