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临床试验/NCT00162617
NCT00162617Unknown4 期

The Effect of Liberal vs. Restrictive Transfusion Strategies on Rehabilitation After Hip Fracture Surgery

Hvidovre University Hospital2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2004年1月最近更新:
适应症
相关药物

试验速览

阶段
4 期
入组人数
120
试验地点
2
主要终点
Postoperative Functional mobility

研究概览

简要总结

To examine the effect of two different transfusion regimens on rehabilitation after hip fracture surgery.

详细描述

The effect of liberal vs restrictive transfusion regimens after hip fracture surgery is unresolved. Liberal transfusion regimens (transfusion trigger hgb. 6.25 mmol/l) leads to an increased use of blood products but may impact positively on rehabilitation outcome, a restrictive transfusion trigger (hbg. 5.0 mmol/l) saves blood products but may also impair postoperative rehabilitation and outcome. the study randomizes 120 elderly patients with hip fractures to either a restrictive or a liberal perioperative transfusion therapy and measures postoperative rehabilitation outcomes within a well defined multimodal rehabilitation regimen.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double

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

  • Primary hip fracture
  • capable of informed consent
  • independently dwelling
  • able to ambulate independent of human assistance
  • no active heart condition defined as no AMI within 3 months, no unstable angina or present incompensation/pulmonary oedema
  • no regular transfusion demand or terminal disease.

排除标准

  • Multiple fractures
  • postop. immobilization due to to surgical reasons
  • patient refusal to participate in relevant rehabilitation
  • reoperation within
  • postoperative day.

结局指标

主要结局

Postoperative Functional mobility

Restricting factors for functional mobility

次要结局

  • Dizziness
  • Exhaustion
  • Haematoma (leg swelling)
  • Length of stay
  • Complications

研究者

申办方类型
Other

研究点 (2)

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