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临床试验/NCT02297061
NCT02297061已完成不适用

Study on the Value of Thrombelastogralhy to Pre-operatively Predict Hip Fracture Patients at Risk of Major Blood Loss During and After Surgery.

Hvidovre University Hospital1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2013年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
180
试验地点
1
主要终点
Total blood loss compared to TEG profile on admission

研究概览

简要总结

Hip fractures are associated with a large hidden blood loss. That is, the total blood loss associated with hip fracture surgery is much greater than that observed intra operatively. There is currently no viable method of identifying patients at risk of transfusion. The on admission haemoglobin level has been shown to be falsely reassuring .

We are conducting a study of 200 consecutive hip fracture patients. Thrombelastography (TEG) is taken on admission. The results are blinded to clinicians. Results will be evaluated at the end of the study, comparing intra-operative and total blood losses with the TEG profile of the patient.

详细描述

Hip fractures are associated with a large hidden blood loss. That is, the total blood loss associated with hip fracture surgery is much greater than that observed intra operatively. The total blood loss depends on the type of fracture and associated surgery. Extra-capsular fractures treated with an intramedullary nail are thus associated with the largest hidden blood loss with a median of approximately 1500 ml . This hidden blood loss is primarily associated with the trauma and fracture itself and not, as such, with the surgical procedure.

Postoperative anaemia necessitating transfusion and a haemoglobin level below 8 g per dL, in hip fracture patients, are both associated with an increased mortality Controversy remains on the benefits and indications for transfusion in this group of patients.

There is currently no viable method of identifying patients at risk of transfusion. The on admission haemoglobin level has been shown to be falsely reassuring . TEG has to our knowledge only been used in one previous study of hip fractures. The outcome measure in this study was thromboembolic events. We have not been able to identify any studies on the use of TEG, INR, APTT or other tests as predictors of blood loss in hip fracture patients.

Clinicians would greatly benefit from a tool to predict the at-risk patient on admission. TEG has been suggested as such a tool. Bolliger et al suggests that TEG can be used in goal-oriented algorithms to optimize targeted transfusion therapies in trauma patients or patients undergoing major surgery. We hypothesize that TEG can be used for this purpose in patients with hip fracture. These patients can have large blood losses and they sustain the double trauma of a hip fracture and major orthopaedic surgery.

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

入选标准

  • All hip fracture patients admitted through the emergency room (ER) at Hvidovre University Hospital in the study period.

排除标准

  • Hip fracture patients who are transfered from other wards in the hospital do not go through the ER and are not included.

结局指标

主要结局

Total blood loss compared to TEG profile on admission

时间窗: 4 days postoperatively

TEG profiles will be compared to the blood losses of the patients, after completion of the study.

次要结局

  • Thrombotic incidences(90 days after operation)
  • Mortality(90 days after operation)

研究者

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

Peter Toft Tengberg

Principal investigator

Hvidovre University Hospital

研究点 (1)

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