Analysis of Red Blood Cell Integrity and Efficiency of Recovery Using a Novel Surgical Sponge-Blood Recovery Device (ProCell)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Level of Plasma Free Hemoglobin
研究概览
简要总结
The purpose of this research study is to compare two methods of recovering blood from surgical sponges used during heart and lung surgeries. The two methods are: 1) manually wringing sponges by hand, and 2) automated wringing sponges by an FDA approved suction device. Both methods are already in use in heart and lung surgeries at University Hospitals at the discretion of the surgeon.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
Subjects will be blinded to the order of intervention.
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing heart or lung transplant, redo sternotomy, aortic surgery, and/or multi-valve repairs/replacements; and
- •At University Hospitals Cleveland Medical Center.
排除标准
- •Patients with known bleeding disorders, including disseminated intravascular coagulation (DIC), prothrombin deficiency, factor V deficiency, factor VII deficiency, factor X deficiency, factor XI deficiency (hemophilia C), Glanzmann disease, hemophilia A, hemophilia B, idiopathic thrombocytopenic purpura (ITP), and Von Willebrand disease (types I, II, and III);
- •Patients undergoing emergent or emergent salvage surgery; and
- •Patients actively participating in another clinical trial which could affect outcomes.
结局指标
主要结局
Level of Plasma Free Hemoglobin
时间窗: Post-Processing (Up to 120 Minutes)
Level of plasma free hemoglobin will be measured post-processing.
Change in Volume of Blood
时间窗: Baseline, Post-Processing (Up to 120 Minutes)
Volume of blood will be measured at baseline and post-processing.
Level of Plasma Free Hemoglobin
时间窗: Baseline
Level of plasma free hemoglobin will be measured at baseline.
次要结局
- Number of Fragmented Red Blood Cells(Post-Processing (Up to 120 Minutes))
- Level of Lactate Dehydrogenase(Post-Processing (Up to 120 Minutes))
- Time to Wring Sponges(Up to 120 Minutes)
- Level of Haptoglobin(Post-Processing (Up to 120 Minutes))
- Change in Weight of Surgical Sponge(Baseline, Post-Procedure (Up to 5 Minutes))
- Number of Fragmented Red Blood Cells(Baseline)
- Level of Lactate Dehydrogenase(Baseline)
- Level of Haptoglobin(Baseline)
研究者
Mohammad El Diasty
Division Chief, Cardiac Surgery, UH Cleveland Medical Center
University Hospitals Cleveland Medical Center