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临床试验/NCT04304287
NCT04304287已完成不适用

The Benefit of Autologous Blood Transfusion in Total Hip Arthroplasty

Clinical Hospital Centre Zagreb0 个研究点目标入组 75 人开始时间: 2011年1月16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
75
主要终点
Patient red blood cells value

研究概览

简要总结

The investigators studied the benefit of preoperative autologous blood donation in participants who undergo total hip arthroplasty. Study is made as a prospective and randomized.

详细描述

Total hip arthroplasty is procedure followed with large perioperative and postoperative blood loss. In order to avoid the application of large amounts of allogeneic blood, preoperative autologous blood donation as a tipe of autologous transfusion have been developed.

In this study, the investigators studied the benefit of preoperative autologous blood donation in participants who undergo total hip arthroplasty. Study is made as a prospective and randomized.

Participants were divided into three groups: the first group donated one dose of autologous blood 14 days preoperatively, the second group donated one dose of autologous blood 72 hours preoperatively and a third group was not donated autologous blood.

The blood parameters, hemodynamic stability, bleeding, the need for application of autologous or homologous blood and length of hospital stay were compared.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Investigator)

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

  • subject older than 18 years
  • subject has primary coxarthrosis
  • subject has indication for total hip replacement

排除标准

  • subject has secondary coxarthrosis
  • subject has need for revision endoprosthesis
  • history of autoimmune, malignancy or coagulation disorder
  • history of myocardial infarct or cerebrovascular insult in last 6 months
  • history of angina pectoris and unregulated hypertension
  • history of renal or liver failure

结局指标

主要结局

Patient red blood cells value

时间窗: 6 days

analysis of blood sample day before surgery, 3 hours after surgery, on first, second, fifth postoperative day and on sixth postoperative day

Patient hematocrit value

时间窗: 6 days

analysis of blood sample day before surgery, 3 hours after surgery, on first, second, fifth postoperative day and on sixth postoperative day

Need for autologous blood transfusion

时间窗: 6 days

Based on blood count and hemodynamic stability

Need for homologous blood transfusion

时间窗: 6 days

Based on blood count and hemodynamic stability

Patient hemoglobin value

时间窗: 6 days

analysis of blood sample day before surgery, 3 hours after surgery, on first, second, fifth postoperative day and on sixth postoperative day

次要结局

  • Length of hospital stay(6 days)

研究者

发起方
Clinical Hospital Centre Zagreb
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zrinka Oreskovic

Principal investigator

Clinical Hospital Centre Zagreb

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