HemorrhageFinnPHWBNCT05744583
Finnish Prehospital Whole Blood Study
A study testing Packed red cell transfusion and Whole blood transfusion in people with Hemorrhage, run by Finnish Red Cross Blood Service at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhage
- What is being tested?
- Packed red cell transfusion and Whole blood transfusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteFinland
- Study dates
- 1 Nov 2022to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -All adult patients that have been given a blood transfusion during prehospital emergency care
Who cannot join
- Age less than 18 years
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
PH00
Lahti, 15850
Timo Jama, MD, +358 44 4406639, timo.jama@paijatha.fi
Tommi Vaaherma, RN, +358 44 4824179, tommi.vaaherma@paijatha.fi
About this study
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.
Read the 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.
- Conditions
- Hemorrhage
- Being tested
- Packed red cell transfusion, Whole blood transfusion
- Keywords
- Transfusion, Prehospital emergency care
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Packed red cell transfusionOther
Type O RhD negative packed red cell transfusion during prehospital emergency care
Whole blood transfusionOther
Type O RhD positive, low titer whole blood transfusion during prehospital emergency care
| Study group | Role | What they receive |
|---|---|---|
| Packed red blood cell | Active comparator | control Receives: Other: Packed red cell transfusion |
| Low titer whole blood | Experimental | case Receives: Other: Whole blood transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe coagulopathy
Number of patients having severe coagulopathy (measured as INR of = 1.5)
Measured: within 30 minutes upon arrival to the hospital
Secondary outcomes (10)
Coagulopathy
Number of patients having coagulopathy (INR >1.2)
Measured: within 30 minutes upon arrival to the hospital
Time spend at the scene
Time (min) from arrival of transfusion capable unit at the scene to depart of the patient to the hospital.
Measured: 1-500 minutes
Number of patients needing massive transfusion protocol
Need for massive transfusion protocol at hospital
Measured: During first 24 hours after arrival to the 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)
Measured: 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
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)
Measured: 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.
Number of patients with acute lung injury
Number of patients with acute lung injury according to Berlin definition
Measured: 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
In-hospital mortality
Mortality during initial hospitalization period
Measured: 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
24 hour mortality
Any mortality during first 24 hours from event
Measured: 24 hours from the event
Serious adverse effects
Any serious adverse effect within 30 days
Measured: 30 days from the event
Adverse effects
Any adverse effect excluding anti-D formation of D-negative patients within 30 days.
Measured: 30 days from the event
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start1 Nov 2022
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Finnish Red Cross Blood Service
- Sponsor type
- University, hospital or other
- Collaborators
- Helsinki University Central Hospital, Tampere University Hospital, Päijät Häme Central Hospital
- Responsible party
- Principal investigator, Jouni Lauronen, Finnish Red Cross Blood Service
- Investigators
- Jouni Lauronen, MD, PhD, Principal investigator, Finnish Red Cross Blood Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05744583
- Sponsor's protocol ID
- FinnPHWB
- Acronym
- FinnPHWB
- Status last verified
- Jan 2024
- First submitted
- 23 Dec 2022
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Finnish Prehospital Whole Blood Study
- ClinicalTrials.gov ID
- NCT05744583
- Acronym / sponsor ID
- FinnPHWB / FinnPHWB
- Conditions
- Hemorrhage
- Keywords
- Transfusion, Prehospital emergency care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Finnish Red Cross Blood ServiceUniversity, hospital or other
- Collaborators
- Helsinki University Central Hospital, Tampere University Hospital, Päijät Häme Central Hospital
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 27 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Packed red blood cell | Active comparator | Other: Packed red cell transfusioncontrol |
| Low titer whole blood | Experimental | Other: Whole blood transfusioncase |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -All adult patients that have been given a blood transfusion during prehospital emergency care
Key exclusion criteria (1 listed)
- Age less than 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Packed red cell transfusionType O RhD negative packed red cell transfusion during prehospital emergency care | Other | Packed red blood cell |
| Whole blood transfusionType O RhD positive, low titer whole blood transfusion during prehospital emergency care | Other | Low titer whole blood |
Primary outcome
Severe coagulopathy
Time frame: within 30 minutes upon arrival to the hospital
Number of patients having severe coagulopathy (measured as INR of = 1.5)
10 secondary outcomes
Coagulopathy
Time frame: within 30 minutes upon arrival to the hospital
Time spend at the scene
Time frame: 1-500 minutes
Number of patients needing massive transfusion protocol
Time frame: During first 24 hours after arrival to the hospital
Time treated at the hospital
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.
Time treated at the intensive care unit
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.
Number of patients with acute lung injury
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
In-hospital mortality
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
24 hour mortality
Time frame: 24 hours from the event
Serious adverse effects
Time frame: 30 days from the event
Adverse effects
Time frame: 30 days from the event
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jouni Lauronen, MD, PhD principal investigator
Finnish Red Cross Blood Service
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Packed red cell transfusion and Whole blood transfusion in people with Hemorrhage, run by Finnish Red Cross Blood Service at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jouni Lauronen, MD, PhD (+358 50 3741177, jouni.lauronen@veripalvelu.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severe coagulopathy (time frame: within 30 minutes upon arrival to the hospital). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.