Use of a Novel Fibrin Sealant in Total Knee Arthroplasty: A Prospective Randomized Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Total Blood Loss
研究概览
简要总结
Applying a fibrin spray, after knee device implantation, will help in reducing patient blood loss and decrease the drop in both hemoglobin and hematocrit levels. Also, with decreased blood loss there should be a reduced need for blood transfusions.
详细描述
Study Design
Study design and control methods:
This study is designed as a prospective, randomized, double-blinded controlled clinical trial to compare the effect of a fibrin spray applied to the surgical wound as compared to patients not receiving the fibrin spray.
Treatment group:
The subjects will be randomly assigned to the fibrin treatment group or to the control group at the time of the surgery via the opening of a randomly selected sealed envelope. The patient and the independent reviewer will be blinded as to which treatment group the patient is assigned to. This information will be linked to a confidential database for later review by the principal investigator.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients must be male or female of any race
- •Ages 18-80 years old
- •Patients must be undergoing an elective, primary knee arthroplasty performed by the principal investigator
排除标准
- •Allergy or intolerance to the study materials
- •Surgical intervention during the past month for the treatment of the painful joint or its underlying etiology
- •History of previous surgeries on the affected joint including previous arthroscopy (open surgeries)
- •Women that are pregnant or may become pregnant
- •Patient declines to participate
研究组 & 干预措施
Treatment Group--Evicel Fibrin Spray
Patient will receive the fibrin spray after implantation of device but before the wound is closed.
Patients will be randomized to receive spray or not and postop parameters measured.
干预措施: Evicel Fibrin Spray (Drug)
结局指标
主要结局
Total Blood Loss
时间窗: Collected during surgery and in first 2-3 days after surgery
Combination of intraoperative and postoperative blood loss for participants.
Primary--Percent Change of Pre- to Post-Operative Hemoglobin
时间窗: Pre-operative to 1 month
Pre-operative hemoglobin values from routine CBC no earlier than 1 month prior to surgery were compared to post-operative hemoglobin values from routine CBC after surgery.
次要结局
- Total Transfusions(3 days)
- Postoperative Blood Loss(3 days)
研究者
Brett Levine, MD
Assistant Professor and Associate Residency Director
Rush University Medical Center