Finnish Prehospital Whole Blood Study

NCT05744583 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2024-01-05

No results posted yet for this study

Summary

Up-to-date evidence suggests that blood transfusion initiated as early as possible reduces the likelihood of death from hemorrhagic shock, and the sooner replacement therapy with blood products is initiated, the greater the effect on mortality. Typically, the patient is transfused with one to two units of O RhD (Rh blood group D antigen) negative packed red blood cells (PRBC). Hemostasis accelerating medicines (dry plasma, tranexamic acid, calcium, fibrinogen) as well as crystalloids are also often given.

Finnish Red Cross Blood Service is validating cold stored, 0 RhD positive, male donor, leucoreduced, platelet sparing, low blood group ABO antibody titer whole blood product (LTOWB). For this prospective, open, non-randomized clinical study LTOWB will be used in three prehospital emergency medical services that currently use most of prehospital blood products in Finland, while other participating prehospital emergency medical service bases provide controls. Blood transfusions will be given for clinical indication only.

The primary goal is to introduce LTOWB and to analyze its feasibility in Finnish prehospital emergency medical service. Study also aims to prove safety of LTOWB, and to analyze coagulation properties of LTOWB compared to currently prehospitally used PRBC transfusions.

Conditions

Interventions

OTHER

Packed red cell transfusion

Type O RhD negative packed red cell transfusion during prehospital emergency care

OTHER

Whole blood transfusion

Type O RhD positive, low titer whole blood transfusion during prehospital emergency care

Sponsors & Collaborators

  • Helsinki University Central Hospital

    collaborator OTHER
  • Tampere University Hospital

    collaborator OTHER
  • Päijät Häme Central Hospital

    collaborator OTHER
  • Finnish Red Cross Blood Service

    lead OTHER

Principal Investigators

  • Jouni Lauronen, MD, PhD · Finnish Red Cross Blood Service

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2025-12-30
Completion
2026-06-30

Countries

  • Finland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05744583 on ClinicalTrials.gov