Finnish Prehospital Whole Blood Study
NCT05744583 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300
Last updated 2024-01-05
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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