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Transfusion for Major Haemorrhage in Trauma - Characteristics and Outcomes

Transfusion for Major Haemorrhage in Trauma - Characteristics and Outcomes

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05573841
Enrollment
161
Registered
2022-10-10
Start date
2022-10-31
Completion date
2025-02-28
Last updated
2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coagulopathy, Hemorrhage, Shock, Traumatic, Trauma

Brief 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. 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: i) 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.

Interventions

None listed

Sponsors

Karolinska University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* All trauma patients admitted to the trauma unit at the Karolinska University Hospital Solna.

Exclusion criteria

* Patients with injuries från hanging, drowning, burns or smoke inhalation.

Design outcomes

Primary

MeasureTime frame
Survival30 day

Secondary

MeasureTime frame
Trauma-induced coagulopathy defined as INR > 1.2Admission to 24 hours
Survival24 hour
Volume of transfusionAdmission to 24 hours

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 31, 2026