Finnish Prehospital Whole Blood Study

NCT05744583 | Recruiting

• 1 other identifier: FinnPHWB
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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

Hemorrhage

Keywords

Transfusion; Prehospital emergency care

Outcome Measures

Primary Outcomes (1)

• Severe coagulopathy

  Number of patients having severe coagulopathy (measured as INR of = 1.5)

  within 30 minutes upon arrival to the hospital

Secondary Outcomes (10)

• Coagulopathy

  within 30 minutes upon arrival to the hospital

• Time spend at the scene

  1-500 minutes

• Number of patients needing massive transfusion protocol

  During first 24 hours after arrival to the hospital

• Time treated at the hospital

  From day 0 (arrival to the hospital) to the date of discharge from the hospital or date of death from any cause, whichever came first, assessed up to 36 months.

• Time treated at the intensive care unit

  From day 0 (arrival to ICU) to the date of discharge/removal to the ward or date of death, whichever came first, assessed up to 36 months.

Study Arms (2)

Packed red blood cell

ACTIVE COMPARATOR

control

Other: Packed red cell transfusion

Low titer whole blood

EXPERIMENTAL

case

Other: Whole blood transfusion

Interventions

Packed red cell transfusion OTHER

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

Packed red blood cell

Whole blood transfusion OTHER

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

Low titer whole blood

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All adult patients that have been given a blood transfusion during prehospital emergency care

You may not qualify if:

• \- Age less than 18 years

Sponsors & Collaborators

• Finnish Red Cross Blood Service: lead
• Helsinki University Central Hospital: collaborator
• Tampere University Hospital: collaborator
• Päijät Häme Central Hospital: collaborator

Study Sites (1)

PH00

Lahti, 15850, Finland

RECRUITING

MeSH Terms

Conditions

Hemorrhage

Interventions

Exchange Transfusion, Whole Blood

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Transfusion; Biological Therapy; Therapeutics

Study Officials

• Jouni Lauronen, MD, PhD

  Finnish Red Cross Blood Service

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jouni Lauronen, MD, PhD

CONTACT

+358 50 3741177; jouni.lauronen@veripalvelu.fi

Timo Jama, MD

CONTACT

+358 44 4406639; timo.jama@paijatha.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Non-randomized, open label design. 3 centers use whole blood while others use packed red cells as pre-hospital transfusion therapy. Only study related intervention is additional blood samples from sub-group of patients for in vivo coagulation studies.

Study Record Dates

• First Submitted: December 23, 2022
• First Posted: February 27, 2023
• Study Start: November 1, 2022
• Primary Completion: December 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 5, 2024

Record last verified: 2024-01

Locations

FI (1)