HemorrhageNCT04879485
Prehospital Transfusion Strategy in Bleeding Patients
A study testing Blood products in people with Hemorrhage and Blood Component Transfusion, run by University of Aarhus at 2 sites in Denmark.
Trial summary
The aim of study is to compare clinical and biochemical effect of three different transfusion strategies among patients with major hemorrhage requiring prehospital transfusion. A) Present prehospital standard treatment including a mixture of plasma and Red blood cell transfusion (RBC) transfusion B) Red blood cell… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhage, Blood Component Transfusion
- What is being tested?
- Blood products
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesDenmark
- Study dates
- 3 May 2021to 31 Dec 2024
- 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
- Major bleeding requiring prehospital transfusion
Who cannot join
- Transfusion with blood products already initiated
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Danish Air Ambulance
Aarhus
Aarhus Universityhospital
Silkeborg, Central Jutland, 8600
About this study
Official title: Prehospital Plasma or Red Blood Cell Transfusion Strategy in Major Bleeding; PRIEST Trial
The aim of study is to compare clinical and biochemical effect of three different transfusion strategies among patients with major hemorrhage requiring prehospital transfusion.
- Present prehospital standard treatment including a mixture of plasma and Red blood cell transfusion (RBC) transfusion B) Red blood cell transfusion (RBC) only C) Plasma transfusion only
Hypothesis:
- Transfusion strategy including a mixture of RBC and plasma is superior as compared with only plasma or only RBC strategy in terms of initial treatment of circulatory shock (expressed as base deficit).
- Endothelial function and ability of clot formation is preserved to a greater extent in patients receiving plasma.
Read the detailed description
Rationale for the study:
The warranted clinical question to be unsolved is whether initial pre-hospital transfusion in bleeding patients should base on a strategy including plasma, RBC or combination of both.
Despite possible benefits, allogenic blood product are associated with side effects and pose significant logistic challenges in the prehospital environment. So far, a majority of the present knowledge is based on retrospective evaluations or clinical trials without relevant control groups.
- Conditions
- Hemorrhage, Blood Component Transfusion
- Being tested
- Blood products
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood productsBiological
Compare two different transfusion strategies against standard transfusion regimen
| Study group | Role | What they receive |
|---|---|---|
| Standard transfusion | No intervention | Includes standard transfusion with a mixture of red blood cells and plasma |
| Plasma | Active comparator | Transfusion with plasma Receives: Biological: Blood products |
| Red Blood cells | Active comparator | Transfusion with red blood cells Receives: Biological: Blood products |
What is being measured
The primary outcome is the main question the study is designed to answer.
Base deficit
Arterial-gas analysis upon arrival with parameter base deficit as primary outcome
Measured: At hospital arrival (with in 1 hour)
Secondary outcomes (9)
30 days mortality
Mortality, follow up in patient records
Measured: mortality within 30 days
Activated Partial Thromboplastin Time (APTT)
Plasma sample analysed; APTT
Measured: At hospital arrival (with in 2 hours)
Endogenous thrombin potential (ETP)
Plasma sample analysed; thrombin generation assay
Measured: At hospital arrival (with in 2 hours)
International Normalized Ratio (INR)
Plasma sample analysed; INR
Measured: At hospital arrival (with in 2 hours)
Endothelium markers
Plasma sample analysed; Syndecan-1
Measured: At hospital arrival (with in 2 hours)
Endothelium markers
Plasma sample analysed; soluble thrombomodulin
Measured: At hospital arrival (with in 2 hours)
In hospital red blood cell transfusion requirements
Amount of red blood cells transfused as registered in patient electronic records
Measured: Within in the first 24 hours after hospital arrival
In hospital plasma transfusion requirements
Amount of plasma transfused as registered in patient electronic records
Measured: Within in the first 24 hours after hospital arrival
In hospital platelet transfusion requirements
Amount of platelet transfused as registered in patient electronic records
Measured: Within in the first 24 hours after hospital arrival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start3 May 2021
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemorrhageStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Air Ambulance Foundation, Odense University Hospital, Copenhagen University Hospital, Denmark
- Responsible party
- Sponsor
- Investigators
- Christian Fenger-Eriksen, Study chair, Aarhus Universityhospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04879485
- Sponsor's protocol ID
- 1-10-72-289-20
- Status last verified
- Jan 2025
- First submitted
- 29 Apr 2021
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Radford M, Estcourt LJ, Sirotich E, Pitre T, Britto J, Watson M, Brunskill SJ, Fergusson DA, Doree C, Arnold DM. Restrictive versus liberal red blood cell transfusion strategies for people with haematological malignancies treated with intensive chemotherapy or radiotherapy, or both, with or without haematopoietic stem cell support. Cochrane Database Syst Rev. 2024 May 23;5(5):CD011305. doi: 10.1002/14651858.CD011305.pub3.
PubMed 38780066
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prehospital Plasma or Red Blood Cell Transfusion Strategy in Major Bleeding; PRIEST Trial
- ClinicalTrials.gov ID
- NCT04879485
- Acronym / sponsor ID
- 1-10-72-289-20
- Conditions
- Hemorrhage, Blood Component Transfusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Norwegian Air Ambulance Foundation, Odense University Hospital, Copenhagen University Hospital, Denmark
- Study start
- 3 May 2021 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 10 May 2021 (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.
The aim of study is to compare clinical and biochemical effect of three different transfusion strategies among patients with major hemorrhage requiring prehospital transfusion.
- Present prehospital standard treatment including a mixture of plasma and Red blood cell transfusion (RBC) transfusion B) Red blood cell transfusion (RBC) only C) Plasma transfusion only
Hypothesis:
- Transfusion strategy including a mixture of RBC and plasma is superior as compared with only plasma or only RBC strategy in terms of initial treatment of circulatory shock (expressed as base deficit).
- Endothelial function and ability of clot formation is preserved to a greater extent in patients receiving plasma.
Detailed description
Rationale for the study:
The warranted clinical question to be unsolved is whether initial pre-hospital transfusion in bleeding patients should base on a strategy including plasma, RBC or combination of both.
Despite possible benefits, allogenic blood product are associated with side effects and pose significant logistic challenges in the prehospital environment. So far, a majority of the present knowledge is based on retrospective evaluations or clinical trials without relevant control groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard transfusion | No intervention | –Includes standard transfusion with a mixture of red blood cells and plasma |
| Plasma | Active comparator | Biological: Blood productsTransfusion with plasma |
| Red Blood cells | Active comparator | Biological: Blood productsTransfusion with red blood cells |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Major bleeding requiring prehospital transfusion
Key exclusion criteria (1 listed)
- Transfusion with blood products already initiated
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 |
|---|---|---|
| Blood productsCompare two different transfusion strategies against standard transfusion regimen | Biological | Plasma, Red Blood cells |
Primary outcome
Base deficit
Time frame: At hospital arrival (with in 1 hour)
Arterial-gas analysis upon arrival with parameter base deficit as primary outcome
9 secondary outcomes
30 days mortality
Time frame: mortality within 30 days
Activated Partial Thromboplastin Time (APTT)
Time frame: At hospital arrival (with in 2 hours)
Endogenous thrombin potential (ETP)
Time frame: At hospital arrival (with in 2 hours)
International Normalized Ratio (INR)
Time frame: At hospital arrival (with in 2 hours)
Endothelium markers
Time frame: At hospital arrival (with in 2 hours)
Endothelium markers
Time frame: At hospital arrival (with in 2 hours)
In hospital red blood cell transfusion requirements
Time frame: Within in the first 24 hours after hospital arrival
In hospital plasma transfusion requirements
Time frame: Within in the first 24 hours after hospital arrival
In hospital platelet transfusion requirements
Time frame: Within in the first 24 hours after hospital arrival
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Derived from this study: PubMed 38780066Radford M, Estcourt LJ, Sirotich E, Pitre T, Britto J, Watson M, Brunskill SJ, Fergusson DA, Doree C, Arnold DM. Restrictive versus liberal red blood cell transfusion strategies for people with haematological malignancies treated with intensive chemotherapy or radiotherapy, or both, with or without haematopoietic stem cell support. Cochrane Database Syst Rev. 2024 May 23;5(5):CD011305. doi: 10.1002/14651858.CD011305.pub3.
- Individual participant dataSharing planned: No
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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.
Christian Fenger-Eriksen study chair
Aarhus Universityhospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood products in people with Hemorrhage and Blood Component Transfusion, run by University of Aarhus at 2 sites in Denmark.
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: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Base deficit (time frame: At hospital arrival (with in 1 hour)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04879485, which also lists 1 linked publication.
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 18 Nov 2025.