Transfusion for Major Haemorrhage in Trauma - Characteristics and Outcomes

Trauma Clinical Trial

Official title:

Transfusion for Major Haemorrhage in Trauma - Characteristics and Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05573841
• Other study ID #: K 2022-5528
• Status: Recruiting
• Start date: October 31, 2022
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: Karolinska University Hospital
• Contact: Magnus Hedberg, MD/PhD
• Phone: +46706595989
• Email: magnus.hedberg[@]regionstockholm.se
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Coagulopathy
• Hemorrhage
• Shock, Traumatic
• Trauma
• Wounds and Injuries

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival		30 day
Secondary	Trauma-induced coagulopathy defined as INR > 1.2		Admission to 24 hours
Secondary	Survival		24 hour
Secondary	Volume of transfusion		Admission to 24 hours