TraumaNCT05573841
Transfusion for Major Haemorrhage in Trauma - Characteristics and Outcomes
An observational study of Trauma and Hemorrhage, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
Background: Trauma is the leading cause of death in young adults worldwide and the most common causes of mortality are haemorrhage and brain injury. About 40% of trauma related deaths are due to massive haemorrhage and approximately 30% of trauma patients have an associated trauma induced coagulopathy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Trauma, Hemorrhage, Shock, Traumatic
- How many people
- 161 participants
- Where
- 1 siteSweden
- Study dates
- 31 Oct 2022to 28 Feb 2025
- How long will I take part?
- 1 Month
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All trauma patients admitted to the trauma unit at the Karolinska University Hospital Solna will be studied. Patients receiving unmatched blood (erythrocytes, plasma or whole blood) either in the prehospital phase or during the first two hours of hospital care will be compared to patients not receiving blood products.
Who may be able to join
- All trauma patients admitted to the trauma unit at the Karolinska University Hospital Solna.
Who cannot join
- Patients with injuries från hanging, drowning, burns or smoke inhalation.
Trial locations and contacts
1 site in 1 country.
About this study
Background: Trauma is the leading cause of death in young adults worldwide and the most common causes of mortality are haemorrhage and brain injury. About 40% of trauma related deaths are due to massive haemorrhage and approximately 30% of trauma patients have an associated trauma induced coagulopathy. In order to improve outcome, the optimal care for the bleeding patient need to be further understood.
Aim: The overall aim of this project is to evaluate characteristics and outcomes in patients receiving blood transfusion in the early phase after major trauma at a Level 1 trauma center in Sweden.
Read more
The specific aims are:
- To describe outcome, characteristics and effects on the coagulation system in patients receiving early blood transfusion compared to those not receiving transfusion in the early phase. ii) To describe outcome, characteristics and effects on the coagulation system in patients receiving prehospital blood transfusion compared to patients where transfusion is initiated in the trauma unit. iii) To describe the effect from concurrent treatment with procoagulant drugs and intravenous fluids on outcome, characteristics and effects on the coagulation system in patients receiving blood transfusion after major trauma.
Method: This is an observational study of trauma patients admitted to the Trauma Unit at the Karolinska University Hospital Solna, Stockholm, Sweden. Data from patients receiving blood transfusion (erythrocytes, plasma or whole blood) in the early phase of the resuscitation will be collected. All patients receiving transfusion within two hours from arrival will be included. Data on trauma details, injuries, physiological parameters, coagulations tests and treatment will be collected prospectively and from existing registries. The control group will consist of patients not receiving transfusion during the first two hours of care.
- Conditions
- Trauma, Hemorrhage, Shock, Traumatic, Acute Coagulopathy
- Medical subject headings
- Wounds and Injuries, Hemorrhage, Shock, Traumatic
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Measured: 30 day
Secondary outcomes (3)
Trauma-induced coagulopathy defined as INR > 1.2
Measured: Admission to 24 hours
Survival
Measured: 24 hour
Volume of transfusion
Measured: Admission to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start31 Oct 2022
- Primary completion31 Dec 2024
- Study completion28 Feb 2025
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 TraumaStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 161 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magnus Hedberg, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05573841
- Sponsor's protocol ID
- K 2022-5528
- Status last verified
- Mar 2025
- First submitted
- 6 Oct 2022
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
von Oelreich E, Eriksson J, Arnason B, Ohlen D, Hedin A, Gille A, Fagerlund MJ, Hedberg M. Blunt versus penetrating trauma: differences in early physiology, coagulopathy, and outcomes in a Scandinavian trauma centre. Scand J Trauma Resusc Emerg Med. 2026 Aug 29;34(1):147. doi: 10.1186/s13049-026-01683-5.
PubMed 42681637
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transfusion for Major Haemorrhage in Trauma - Characteristics and Outcomes
- ClinicalTrials.gov ID
- NCT05573841
- Acronym / sponsor ID
- K 2022-5528
- Conditions
- Trauma, Hemorrhage, Shock, Traumatic, Acute Coagulopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- 31 Oct 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 10 Oct 2022 (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.
Background: Trauma is the leading cause of death in young adults worldwide and the most common causes of mortality are haemorrhage and brain injury. About 40% of trauma related deaths are due to massive haemorrhage and approximately 30% of trauma patients have an associated trauma induced coagulopathy. In order to improve outcome, the optimal care for the bleeding patient need to be further understood.
Aim: The overall aim of this project is to evaluate characteristics and outcomes in patients receiving blood transfusion in the early phase after major trauma at a Level 1 trauma center in Sweden.
The specific aims are:
- To describe outcome, characteristics and effects on the coagulation system in patients receiving early blood transfusion compared to those not receiving transfusion in the early phase. ii) To describe outcome, characteristics and effects on the coagulation system in patients receiving prehospital blood transfusion compared to patients where transfusion is initiated in the trauma unit. iii) To describe the effect from concurrent treatment with procoagulant drugs and intravenous fluids on outcome, characteristics and effects on the coagulation system in patients receiving blood transfusion after major trauma.
Method: This is an observational study of trauma patients admitted to the Trauma Unit at the Karolinska University Hospital Solna, Stockholm, Sweden. Data from patients receiving blood transfusion (erythrocytes, plasma or whole blood) in the early phase of the resuscitation will be collected. All patients receiving transfusion within two hours from arrival will be included. Data on trauma details, injuries, physiological parameters, coagulations tests and treatment will be collected prospectively and from existing registries. The control group will consist of patients not receiving transfusion during the first two hours of care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All trauma patients admitted to the trauma unit at the Karolinska University Hospital Solna will be studied. Patients receiving unmatched blood (erythrocytes, plasma or whole blood) either in the prehospital phase or during the first two hours of hospital care will be compared to patients not receiving blood products.
Key inclusion criteria (1 listed)
- All trauma patients admitted to the trauma unit at the Karolinska University Hospital Solna.
Key exclusion criteria (1 listed)
- Patients with injuries från hanging, drowning, burns or smoke inhalation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Survival
Time frame: 30 day
3 secondary outcomes
Trauma-induced coagulopathy defined as INR > 1.2
Time frame: Admission to 24 hours
Survival
Time frame: 24 hour
Volume of transfusion
Time frame: Admission to 24 hours
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 10 Aug 2026.
- Derived from this study: PubMed 42681637von Oelreich E, Eriksson J, Arnason B, Ohlen D, Hedin A, Gille A, Fagerlund MJ, Hedberg M. Blunt versus penetrating trauma: differences in early physiology, coagulopathy, and outcomes in a Scandinavian trauma centre. Scand J Trauma Resusc Emerg Med. 2026 Aug 29;34(1):147. doi: 10.1186/s13049-026-01683-5.
- Individual participant dataSharing planned: No
Related trials for Trauma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
Safety Study of Microlyte DualGuard
Wound Closure, Wound Care
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma and Hemorrhage, run by Karolinska University Hospital at 1 site in Sweden.
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 10 Aug 2026. 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 Sweden. 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?
Survival (time frame: 30 day). 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 NCT05573841, 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 10 Aug 2026.