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临床试验/NCT05573841
NCT05573841已完成不适用

Transfusion for Major Haemorrhage in Trauma - Characteristics and Outcomes

Karolinska University Hospital1 个研究点 分布在 1 个国家目标入组 161 人开始时间: 2022年10月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
161
试验地点
1
主要终点
Survival

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者
否

入选标准

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

排除标准

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

结局指标

主要结局

Survival

时间窗: 30 day

次要结局

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

研究者

发起方
Karolinska University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Magnus Hedberg

Principal Investigator, MD, PhD

Karolinska University Hospital

研究点 (1)

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