The Use of FLOSEAL to Reduce Bleeding in Total Knee Replacement Surgery
The Role of a Topical Hemostatic Agent in Reducing Blood Loss in Unilateral Total Knee Arthroplasty
研究概览
详细说明
This is a prospective double blind randomized clinical trial of patients requiring unilateral total knee arthroplasty. The patients will be randomized intra-operatively to receiving Floseal or no treatment.
Both the patient and the observers will be blinded to whether the subject received Floseal or no treatment. Only the operating surgeons will be aware of whether Floseal or no treatment was given.
As was performed in the pilot study, randomization of Floseal or no treatment will be performed using the sealed envelope technique. Randomization will occur at the time of surgery. The statistician is responsible for maintaining the randomization schedule and issuing the sealed envelopes. The inner envelope will contain whether Floseal or no treatment is to be given on a card which will be counter-signed by the surgeon at the time of surgery. The inner envelope will then be sealed, followed by sealing of the outer envelope. Following the procedure, the surgeon will then take the sealed and signed envelope to surgeon who will store and file it in a locked cabinet in his office. The patients study number will be on the outside surface of the envelopes.
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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New York
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New York、New York、美国、10021
- Hospital for Special Surgery
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Single Knee replacement for arthritis of the knee
Exclusion Criteria:
- No inflammatory arthritis (ie. Rheumatoid arthritis)
- No allergies to cow meat (bovine allergies
- No history of bleeding disorders
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
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无干预:控制
没有干预。
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实验性的:Hemostatic Matrix
2 vials of Floseal applied once at the end of surgery
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FloSeal will be administered following the cementing of all knee components.
Prior to release of the tourniquet and after the cement has cured, it will be applied to cut, exposed bone ends as well as the intra-articular soft tissues by the use of a delivery syringe, Direct manual pressure with a gauze sponge will be applied following its application for 2 minutes, ensuring that it adheres to the bleeding bone surface.
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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与术前相比,第 0 天血红蛋白的变化
大体时间:术前和手术当天
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术前和手术当天
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与术前相比,第 1 天血红蛋白的变化
大体时间:术前和术后一天
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术前和术后一天
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与术前相比,第 2 天血红蛋白的变化
大体时间:术前和术后两天
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术前和术后两天
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与术前相比,第 2 天血细胞比容的变化
大体时间:术前和术后两天
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术前和术后两天
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Change in Hemoglobin on Day 0 Compared to Preoperatively
大体时间:preoperatively and day of surgery
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preoperatively and day of surgery
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Change in Hematocrit on Day 1 Compared to Preoperatively
大体时间:preoperatively and 1 day after surgery
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preoperatively and 1 day after surgery
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Drain Output
大体时间:24 hours postoperatively
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24 hours postoperatively
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Autologous Amount of Transfusion
大体时间:three days postoperatively
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three days postoperatively
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Homologous Amount of Transfusion
大体时间:three days postoperatively
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three days postoperatively
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Range of Motion on Day 3
大体时间:3days postoperatively
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3days postoperatively
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Visual Analog Pain Scale on Day 3
大体时间:3 days postoperatively
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A VAS is a measurement instrument that tries to measure a characteristic or attitude that cannot easily be measured. The pain VAS scale measures pain intensity on a scale of 0 to 10, with 0=no pain. A higher score indicates greater pain intensity. |
3 days postoperatively
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Range of Motion at Six Weeks
大体时间:6 weeks postoperatively
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6 weeks postoperatively
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Visual Analog Pain Scale at 6 Weeks
大体时间:6 weeks postoperatively
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A VAS is a measurement instrument that tries to measure a characteristic or attitude that cannot easily be measured. The pain VAS scale measures pain intensity on a scale of 0 to 10, with 0=no pain. A higher score indicates greater pain intensity. |
6 weeks postoperatively
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合作者和调查者
调查人员
- 首席研究员:Mark P Figgie, MD、Hospital for Special Surgery, New York
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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