Retrospective & Prospective Evaluation/Analysis of Hb/Hct in Patients Having Received FloSeal (5ml &10ml) When Undergoing Total Knee or Total Hip Arthroplasty
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 1
研究概览
简要总结
The purpose of this analysis is to compare Hemoglobin and Hematocrit levels following total hip or knee arthroplasty. The utilization of FloSeal intraoperatively will improve hemostasis postoperatively. Decreasing bleeding time will decrease the drop in level of Hemoglobin and Hematocrit which usually occurs postoperatively.
详细描述
Retrospective Analysis of charts on patients having undergone Total Hip or Total Knee Arthroplasty. During the patient's hospitalization, lab values of Hg and Hct will be recorded for further analysis. Preoperative levels will be also noted to establish baselines.
Primary Data interest will be Hemoglobin (Hgb) level documented during hospitalization along with Hematocrit (HCT) and Red Blood Cell (RBC) data also collected.
Secondary Data gathered will consist of the following:
- patient Demographics
- Component Profile
- Length of Stay
- Anesthesia used
- Anesthesiologist
- EBL
- drain type
- Amount of drainage fluid recorded at 12 hour increments until discharge
- Amount of FloSeal used
- Type of Arthroplasty
500 patients in Total
- 100 Historical Control Patients, knees - no FloSeal (retrospective)
- 100 Patients, knees - 5mL FloSeal (retrospective)
- 100 Patients, knees- 10mL FloSeal (prospective)
- 100 Historical Control patients, hips-no FloSeal (retrospective)
- 100 retrospective patients, hips-5mL of FloSeal (retrospective
研究设计
- 研究类型
- Observational
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Total Knee and Total Hip Patients
- •Surgical Time less than 2 hours
排除标准
- •Patients who require greater than 2 hour surgeries
- •Patients who are undergoing revision arthroplasty
- •Patients with known allergies to materials of bovine origin