Transfusion for Major Haemorrhage in Trauma - Characteristics and Outcomes

Sponsor

Karolinska University Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05573841

Collaborator

(none)

300

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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:

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.
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.
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.

Condition or Disease	Intervention/Treatment	Phase
Trauma Hemorrhage Shock, Traumatic Acute Coagulopathy

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Transfusion for Major Haemorrhage in Trauma - Characteristics and Outcomes

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Outcome Measures

Primary Outcome Measures

Survival [30 day]

Secondary Outcome Measures

Trauma-induced coagulopathy defined as INR > 1.2 [Admission to 24 hours]
Survival [24 hour]
Volume of transfusion [Admission to 24 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Karolinska University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Magnus Hedberg, Principal Investigator, MD, PhD, Karolinska University Hospital

ClinicalTrials.gov Identifier:

NCT05573841

Other Study ID Numbers:

K 2022-5528

First Posted:

Oct 10, 2022

Last Update Posted:

Oct 13, 2022

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hemorrhage

Shock, Traumatic

Wounds and Injuries

Study Results

No Results Posted as of Oct 13, 2022