sTErnAl heMostasiS Trial (TEAMS Trial)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Sternal Bleeding Score
研究概览
简要总结
Sternal bleeding remains an unsolved problem for cardiac surgery teams costing operative time, blood loss, and distraction from the critical operative field. As such, the following is an investigator-initiated trial to determine whether application of a topical hemostatic agent reduces sternal bleeding during cardiac surgery using sternotomy approach.
详细描述
This is a prospective randomized 1:1 trial to evaluate the efficacy of the application of HEMOBLASTTM during cardiothoracic surgery to reduce the increased risk of sternal bleeding in 30 treatment and 30 control patients.
Enrollment will be open to all eligible participants undergoing cardiothoracic surgery who sign an informed consent.
The study will also collect demographic data and relevant clinical data, such as medical history, diagnosis, family history, laboratory data, radiological images and reports, and diagnostic procedure reports.
All enrolled subjects will be followed during their hospitalization until discharge for bleeding complications after their surgical procedure as well as a sternal bleeding SPOT GRADE TM score will be recorded independently by both the cardiac surgeon and assisting cardiothoracic PA-C, before and after the application of the topical hemostatic agent. There will be no restriction on the use of electrocautery or vancomycin paste as existing routine adjuncts used in cardiothoracic surgery for sternal hemostasis. Chest tube output measurements will be collected at 6, 12, and 24 hours postoperatively. The patients will be assessed at the time of hospital discharge for any complications related to sternal or intrathoracic bleeding.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
The patient will not know whether they had the hemostatic agent applied during scheduled on pump sternotomy surgery as an additional adjunct to control bleeding.
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients are scheduled to undergo on-pump open chest cardiothoracic surgery.
- •Patients must be willing and able to provide written informed consent.
- •If the patient is of childbearing potential, they must have a negative pregnancy test within 24 hours of the index procedure.
- •Patients must be at least 21 years of age.
- •Patients have at least one of the following risk factors:
- •Undergoing redo sternotomy
- •Have a preoperative platelet count <150 mg/dL
- •Are on dual antiplatelet therapy (blood thinners) < 5 days prior to sternotomy
- •Have a BMI (body mass index)> 35
- •Are undergoing combined CABG (coronary artery bypass surgery)/valve surgery
- •Have chronic kidney disease (GFR <60 ml/min) or ESRD (end stage renal disease)
排除标准
- •Patients who undergo thoracotomy approach
- •Patients who are not deemed an appropriate candidate by the investigator.
- •Patients who are pregnant or nursing, or who plan to become pregnant during the course of this study.
研究组 & 干预措施
Application of Hemoblast Hemostatic Agent
Patients who are randomized to "treatment" will receive application of the Hemoblast hemostatic agent during on pump sternotomy surgery.
干预措施: Hemoblast Bellows application (Drug)
结局指标
主要结局
Sternal Bleeding Score
时间窗: Sternal closure
A sternal bleeding score will be performed independently by surgeon and physician assistant utilizing the SPOT GRADE bleeding scale ranging from 0-5. 0 (no bleeding), 1 (minimal bleeding), 2 (mild bleeding), 3 (moderate bleeding), 4 (severe bleeding), 5 (extreme bleeding)
Reoperation for Bleeding
时间窗: Through hospitalization, average of 6 days
Patients will be monitored for incidences of reoperation due to bleeding
Chest Tube Output
时间窗: 6 hours postoperatively
The patient's chest tube output will be recorded after surgery
次要结局
- Chest Tube Output(12 and 24 hours postoperatively)
研究者
Judson Williams
Principal Investigator
WakeMed Health and Hospitals