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临床试验/NCT03074890
NCT03074890Unknown不适用

Observational Study to Assess the Safety and Clinical Effectiveness of the Hospital Universitario de Canarias Massive Transfusion Protocol

Hospital Universitario de Canarias2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2015年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
2
主要终点
30-day Mortality

研究概览

简要总结

Massive haemorrhage is defined as the necessity of 3 or more packed red blood cells in one hour, the transfusion of 10 packed blood cells, the loss of the half of the blood volume, the loss of 4-5 cc/kg/h or more, and haemorrhage shock.

Haemorrhage shock provokes changes in the bloodstream with celular and organic disfunction. In many cases massive transfusion is needed to stabilize the vital function. This massive transfusion can have serious side effects (infectious and immunologic and no immunologic reactions) and increase the morbidity and mortality.

Massive transfusion protocols improve the survival in severe trauma injury patients. The transfusion of fixed rate of packed red blood cells, fresh frozen plasma and platelet concentrates have decreased the severity of trauma induced coagulopathy.

Recently several studies have shown the benefit of massive transfusion protocols with high transfusion ratios (1:1:1 RBC:FFP:PLT) in mortality after severe trauma. So early and aggressive transfusion improve the outcomes and the resources.

Massive Transfusion Protocol have been elaborated in the Hospital Universitario de Canarias with high transfusion ratios (1:1:1 RBC:FFP:PLT) . The goals of this protocol is to reduce the variability in the clinic experience, to reduce the transfusion necessities and to assure an safe treatment with blood products.

So with this study the investigators will evaluate if the goals of this Protocol are followed and if the use of this Protocol is really safe and efficient.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with massive haemorrhage and surgery
  • Informed consent

排除标准

  • <18 years old patients
  • Patients didn´t want to participate in this study
  • Patients were participated in other studies

结局指标

主要结局

30-day Mortality

时间窗: First 30 day after massive transfusion

Time to Hemostasis

时间窗: admission to hospital discharge or 30 days, whichever comes first

Time to hemostasis refers to the time that the subject achieved hemorrhage control (anatomic hemostasis and resuscitation complete)following emergency department arrival.

次要结局

  • Amount of Blood Products Given From Hemostasis to 24 Hours After(24 hours after admission)
  • Incidence of Massive Transfusion Related Serious Adverse Events(30 days)
  • Severity of coagulopathy associated with high transfusion ratios(30 days post admission)
  • Amount of Blood Products Given to Hemostasis(24 hours from randomization)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

María del Carmen Martín Lorenzo

Dr

Hospital Universitario de Canarias

研究点 (2)

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