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Finnish Prehospital Whole Blood Study (FinnPHWB)

Primary Purpose

Hemorrhage

Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Packed red cell transfusion
Whole blood transfusion
Sponsored by
Finnish Red Cross Blood Service
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemorrhage focused on measuring Transfusion, Prehospital emergency care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: -All adult patients that have been given a blood transfusion during prehospital emergency care Exclusion Criteria: - Age less than 18 years

Sites / Locations

  • PH00Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Packed red blood cell

Low titer whole blood

Arm Description

control

case

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Coagulopathy
Number of patients having coagulopathy (INR >1.2)
Time spend at the scene
Time (min) from arrival of transfusion capable unit at the scene to depart of the patient to the hospital.
Number of patients needing massive transfusion protocol
Need for massive transfusion protocol at hospital
Time treated at the hospital
Time (days) patient is treated at the hospital capable of providing curative treatment to the patients medical condition. Data gathered from patient records (admission to ICU and discharge from ICU date)
Time treated at the intensive care unit
Time (days) patient is treated at the intensive care unit during first ICU episode. Data gathered from patient records (admission to ICU and discharge from ICU date)
Number of patients with acute lung injury
Number of patients with acute lung injury according to Berlin definition
In-hospital mortality
Mortality during initial hospitalization period
24 hour mortality
Any mortality during first 24 hours from event
Serious adverse effects
Any serious adverse effect within 30 days
Adverse effects
Any adverse effect excluding anti-D formation of D-negative patients within 30 days.

Full Information

First Posted
December 23, 2022
Last Updated
February 15, 2023
Sponsor
Finnish Red Cross Blood Service
Collaborators
Helsinki University Central Hospital, Tampere University Hospital, Päijät Häme Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05744583
Brief Title
Finnish Prehospital Whole Blood Study
Acronym
FinnPHWB
Official Title
Finnish Prehospital Whole Blood Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
December 30, 2025 (Anticipated)
Study Completion Date
June 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Finnish Red Cross Blood Service
Collaborators
Helsinki University Central Hospital, Tampere University Hospital, Päijät Häme Central Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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. Since the mid-2010s, prehospital emergency medical services in Finland have used blood transfusions. 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 during pre-hospital emergency treatment. Platelets are not used prehospitally in Finland due to logistic reasons. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhage
Keywords
Transfusion, Prehospital emergency care

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Packed red blood cell
Arm Type
Active Comparator
Arm Description
control
Arm Title
Low titer whole blood
Arm Type
Experimental
Arm Description
case
Intervention Type
Other
Intervention Name(s)
Packed red cell transfusion
Intervention Description
Type O RhD negative packed red cell transfusion during prehospital emergency care
Intervention Type
Other
Intervention Name(s)
Whole blood transfusion
Intervention Description
Type O RhD positive, low titer whole blood transfusion during prehospital emergency care
Primary Outcome Measure Information:
Title
Severe coagulopathy
Description
Number of patients having severe coagulopathy (measured as INR of = 1.5)
Time Frame
within 30 minutes upon arrival to the hospital
Secondary Outcome Measure Information:
Title
Coagulopathy
Description
Number of patients having coagulopathy (INR >1.2)
Time Frame
within 30 minutes upon arrival to the hospital
Title
Time spend at the scene
Description
Time (min) from arrival of transfusion capable unit at the scene to depart of the patient to the hospital.
Time Frame
1-500 minutes
Title
Number of patients needing massive transfusion protocol
Description
Need for massive transfusion protocol at hospital
Time Frame
During first 24 hours after arrival to the hospital
Title
Time treated at the hospital
Description
Time (days) patient is treated at the hospital capable of providing curative treatment to the patients medical condition. Data gathered from patient records (admission to ICU and discharge from ICU date)
Time Frame
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.
Title
Time treated at the intensive care unit
Description
Time (days) patient is treated at the intensive care unit during first ICU episode. Data gathered from patient records (admission to ICU and discharge from ICU date)
Time Frame
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.
Title
Number of patients with acute lung injury
Description
Number of patients with acute lung injury according to Berlin definition
Time Frame
From day 0 (arrival to the hospital) to the date of discharge from the hospital or date of death, whichever came first, assessed up to 36 months
Title
In-hospital mortality
Description
Mortality during initial hospitalization period
Time Frame
From day 0 (arrival to the hospital) to the date of discharge from the hospital or or date of death, whichever came first, assessed up to 36 months
Title
24 hour mortality
Description
Any mortality during first 24 hours from event
Time Frame
24 hours from the event
Title
Serious adverse effects
Description
Any serious adverse effect within 30 days
Time Frame
30 days from the event
Title
Adverse effects
Description
Any adverse effect excluding anti-D formation of D-negative patients within 30 days.
Time Frame
30 days from the event

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: -All adult patients that have been given a blood transfusion during prehospital emergency care Exclusion Criteria: - Age less than 18 years
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jouni Lauronen, MD, PhD
Phone
+358 50 3741177
Email
jouni.lauronen@veripalvelu.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Timo Jama, MD
Phone
+358 40 5514830
Email
timo.jama@paijatha.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jouni Lauronen, MD, PhD
Organizational Affiliation
Finnish Red Cross Blood Service
Official's Role
Principal Investigator
Facility Information:
Facility Name
PH00
City
Lahti
ZIP/Postal Code
15850
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Timo Jama, MD
Phone
+358 40 5514830
Email
timo.jama@paijatha.fi
First Name & Middle Initial & Last Name & Degree
Tommi Vaaherma, RN
Phone
+358 44 4824179
Email
tommi.vaaherma@paijatha.fi

12. IPD Sharing Statement

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Finnish Prehospital Whole Blood Study

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