Prehospital Transfusion Strategy in Bleeding Patients

University of Aarhus

Status: Completed

Conditions: Hemorrhage; Blood Component Transfusion

Treatments: Biological: Blood products

Study type: Interventional

Funder types: Other

Identifiers

NCT04879485

1-10-72-289-20

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Major bleeding requiring prehospital transfusion

Exclusion criteria

• Transfusion with blood products already initiated

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

Standard transfusion

No Intervention group

Description:

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

Plasma

Active Comparator group

Description:

Transfusion with plasma

Treatment:

Biological: Blood products

Red Blood cells

Active Comparator group

Description:

Transfusion with red blood cells

Treatment:

Biological: Blood products