Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
300 participants
INTERVENTIONAL
2022-11-01
2026-06-30
Brief Summary
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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.
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Detailed Description
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The international trend has been the re-emergence of whole blood as the primary replacement product for acute bleeding. 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 (HUS area, Pirkanmaa area and Päijät-Häme area). 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 and its effects on endothelial injury and inflammation compared to currently prehospitally used PRBC transfusions. The primary endpoint of the clinical study is the number of patients having severe coagulopathy (measured as INR of = 1.5) at hospital arrival. The secondary outcomes in order of precedence are: Number of patients having coagulopathy at hospital arrival (INR \>1.2), time at the scene of transfusion capable unit , need for massive transfusion protocol at hospital, discharge from primary hospital, discharge from intensive care unit, number of patients with acute lung injury according to Berlin definition, in-hospital mortality, 24 hour mortality, any serious adverse effect within 30 days, any adverse effect excluding anti-D formation of D-negative patients within 30 days.
Study begins at first quarter of 2022 and recruiting for clinical part of the study continues three years. All adult (=18 years of age) patients who receive prehospital LTOWB or PRBC transfusion during study period in contributing prehospital emergency medical services will be asked to participate using delayed informed consent procedure from patient, or their next of kin if patient is unable due to his/her condition. Consent will not be asked from next of kin and no blood samples for study will be collected, if patient dies before any contact.
In addition to clinical data, a survey that analyses the emergency care team-members' experiences of transfusion events at prehospital setting will be conducted, and prehospital time logs will be compared between the LTOWB and control groups. In addition, separate blood samples will be collected for coagulation, endothelial injury and inflammatory response analyses from subsample of the patients.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Packed red blood cell
control
Packed red cell transfusion
Type O RhD negative packed red cell transfusion during prehospital emergency care
Low titer whole blood
case
Whole blood transfusion
Type O RhD positive, low titer whole blood transfusion during prehospital emergency care
Interventions
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Packed red cell transfusion
Type O RhD negative packed red cell transfusion during prehospital emergency care
Whole blood transfusion
Type O RhD positive, low titer whole blood transfusion during prehospital emergency care
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Helsinki University Central Hospital
OTHER
Tampere University Hospital
OTHER
Päijät Häme Central Hospital
OTHER
Finnish Red Cross Blood Service
OTHER
Responsible Party
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Jouni Lauronen
Principal Investigator
Principal Investigators
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Jouni Lauronen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Finnish Red Cross Blood Service
Locations
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PH00
Lahti, , Finland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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FinnPHWB
Identifier Type: -
Identifier Source: org_study_id
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