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临床试验/NCT02427711
NCT02427711已完成不适用

Reduced Total Blood Loss and Blood Transfusion in Non-Septic Revision Knee Arthroplasty Using a Bipolar Sealer - A Prospective Cohort Study With Retrospective Controls

Hvidovre University Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2013年10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
60
试验地点
1
主要终点
Estimated blood loss

研究概览

简要总结

To investigate if the use of a bipolar sealer for skin and capsula incision results in decreased total blood loss and/or less blood transfusion in non-septic knee arthroplasty.

详细描述

In patients undergoing primary total knee arthroplasty, perioperative anemia is highly prevalent. In a systematic review, preoperative anemia was found in 24 +/- 9% and postoperative anemia in 51% +/- 10%. Perioperative anemia was associated with a blood transfusion rate of 45 +/- 25%, postoperative infections, poorer physical functioning and recovery, and increased length of hospital stay (LOS) and mortality. Although the best transfusion trigger in elective patients remains unknown, restrictive transfusion protocols are recommended and avoidance of blood transfusion if possible.

The only non-systemic modality capable of reducing blood loss before it occurs is a bipolar sealer (Aquamantys). By pre-incisional treatment of the soft tissue, bleeding (and potentially total blood loss and transfusion) is reduced without tissue charring.

Previously studies on the use of Aquamantys in primary knee arthroplasty have had various outcomes, the most recent being negative while the former 3 were positive regarding reduction in blood loss, drop in hgb and transfusions. No published date exist on potential outcomes in revision knee arthroplasty where blood loss and transfusion needs exceeds that of primary total knee arthroplasty by far. Aquamantys hence would theoretically benefit the most in a revision setting without the use of a tourniquet - and would be an interesting modality in modern contemporary fast-track revision if shown effective despite/on top of the use of additional blood saving modalities. The present study is therefore motivated by investigating this aspect.

研究设计

研究类型
Interventional
分配方式
Non 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 undergoing Non septic knee-arthroplasty revision.
  • Musk speak and understand Danish

排除标准

  • Age below 18.

结局指标

主要结局

Estimated blood loss

时间窗: 2nd postoperative morning

次要结局

  • Readmission(90 days after surgery)
  • Blood loss(1st. postoperative morning)
  • Blood transfusion(while hospitalized expected 5 days.)

研究者

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

Christian Skovgaard Nielsen

MD

Hvidovre University Hospital

研究点 (1)

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