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Clinical Trials/NCT05573841
NCT05573841
Recruiting
Not Applicable

Transfusion for Major Haemorrhage in Trauma - Characteristics and Outcomes

Karolinska University Hospital1 site in 1 country300 target enrollmentOctober 31, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Trauma
Sponsor
Karolinska University Hospital
Enrollment
300
Locations
1
Primary Endpoint
Survival
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 31, 2022
End Date
December 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Karolinska University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Magnus Hedberg

Principal Investigator, MD, PhD

Karolinska University Hospital

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Survival

Time Frame: 30 day

Secondary Outcomes

  • Volume of transfusion(Admission to 24 hours)
  • Trauma-induced coagulopathy defined as INR > 1.2(Admission to 24 hours)
  • Survival(24 hour)

Study Sites (1)

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