Finnish Prehospital Whole Blood Study

Hemorrhage Clinical Trial

— FinnPHWB  

Official title:

Finnish Prehospital Whole Blood Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05744583
• Other study ID #: FinnPHWB
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: June 30, 2026

Study information

• Verified date: January 2024
• Source: Finnish Red Cross Blood Service
• Contact: Jouni Lauronen, MD, PhD
• Phone: +358 50 3741177
• Email: jouni.lauronen[@]veripalvelu.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 30, 2026
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Age less than 18 years

Related Conditions & MeSH terms

• Hemorrhage

Intervention

Other:
• 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

Locations

Country	Name	City	State
Finland	PH00	Lahti

Sponsors (4)

Lead Sponsor	Collaborator
Finnish Red Cross Blood Service	Helsinki University Central Hospital, Päijät Häme Central Hospital, Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severe coagulopathy	Number of patients having severe coagulopathy (measured as INR of = 1.5)	within 30 minutes upon arrival to the hospital
Secondary	Coagulopathy	Number of patients having coagulopathy (INR >1.2)	within 30 minutes upon arrival to the hospital
Secondary	Time spend at the scene	Time (min) from arrival of transfusion capable unit at the scene to depart of the patient to the hospital.	1-500 minutes
Secondary	Number of patients needing massive transfusion protocol	Need for massive transfusion protocol at hospital	During first 24 hours after arrival to the hospital
Secondary	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)	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.
Secondary	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)	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.
Secondary	Number of patients with acute lung injury	Number of patients with acute lung injury according to Berlin definition	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
Secondary	In-hospital mortality	Mortality during initial hospitalization period	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
Secondary	24 hour mortality	Any mortality during first 24 hours from event	24 hours from the event
Secondary	Serious adverse effects	Any serious adverse effect within 30 days	30 days from the event
Secondary	Adverse effects	Any adverse effect excluding anti-D formation of D-negative patients within 30 days.	30 days from the event