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OpenTrials
Completed

NCT Number: NCT05573841

Transfusion for Major Haemorrhage in Trauma - Characteristics and Outcomes

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Karolinska University Hospital

Stockholm, 16771, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Survival

    Time frame: 30 day

Secondary outcomes

  1. Trauma-induced coagulopathy defined as INR > 1.2

    Time frame: Admission to 24 hours

  2. Survival

    Time frame: 24 hour

  3. Volume of transfusion

    Time frame: Admission to 24 hours

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Oct 10, 2022
Registry last updated
Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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