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临床试验/NCT01102010
NCT01102010已完成早期 1 期

Postoperative Blood Transfusion for Frail Elderly With Hip Fracture - a Clinical Randomized Controlled Trial

University of Aarhus2 个研究点 分布在 1 个国家目标入组 284 人开始时间: 2010年1月最近更新:
适应症
干预措施

试验速览

阶段
早期 1 期
状态
已完成
入组人数
284
试验地点
2
主要终点
Functional ability

研究概览

简要总结

Elderly with hip fractures are often frail and discharged from hospital after few days of hospitalisation. Hip fracture surgery is often associated with blood loss, where the patient is at risk of developing anaemia. Low haemoglobin level reduces the body's oxygen transport which causes impaired functional ability and strain on vital organs. Acute anaemia is worse tolerated in elderly, than in younger patients. Therefore this study aims to investigate whether there are effects of an expanded indication for blood transfusion in the frail elderly.

详细描述

All elderly patients aged 65 and above who are hospitalised from nursing home or sheltered housing facilities to the Orthopaedic Surgery Ward at Aarhus University Hospital with hip fracture and treated operatively, are eligible for this study. According to sample size calculations 284 patients are needed. Informed consent or deputy informed consent, if the patient is cognitively impaired, is needed. Inclusion is dependent on a haemoglobin measure between 6 and 7 mmol/l 6 days after surgery at the latest. Randomization will be computerised. Randomization will determine intervention with blood transfusion and the measurement of haemoglobin is blinded to the patient, relatives, and endpoint assessor. Both transfusion groups will receive blood when haemoglobin is less than 6 mmol/l, as recommended by the Danish Health and Medicine Authority. Geriatric and Orthopaedic Team (GO-team), consisting of following trained specialists: physiotherapist, nurse, and physician, will conduct medical evaluations, including blood transfusions, from admission until 30 days after surgery. The GO-team will work on weekdays both at the Orthopaedic surgery ward and in the patients home immediately after discharge. In accordance with Aarhus Blood Bank's instructions, blood transfusions are given both under hospitalisation, in the nursing homes and in the sheltered housings. Outcomes are functional ability and mortality during 90 days, and overall quality of life (OQoL) after 30 days and 1 year. The association between physical recovery and OQoL are tested.

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 (Outcomes Assessor)

入排标准

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

入选标准

  • Clinical diagnosis of hip fracture
  • Surgery treatment
  • Living in nursing homes or sheltered housing facilities
  • Haemoglobin level between 6 and 7 mmol/l latest 6th day after surgery
  • Written consent

排除标准

  • Active cancer
  • Pathological fracture
  • The patient is against blood transfusion

研究组 & 干预措施

Blood transfusion

Experimental

Restrictive strategy: Blood transfusion when hemoglobin is less than 6 mmol/l (9.7 g/dl)

Liberal strategy: Blood transfusion when hemoglobin is less than 7 mmol/l (11.3 g/dl)

干预措施: Blood transfusion (Biological)

结局指标

主要结局

Functional ability

时间窗: Measured 10 days after surgery + repeated measurement during 90 days after surgery

Measurement by Cumulated Ambulation Score (CAS), New Mobility Score (NMS) and Modified Barthel Index (MBI)

次要结局

  • Quality of Life(Measured 30 days and 1 year after surgery)
  • Mortality(Measured 30 and 90 days after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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