Analysis of Red Blood Cell Integrity and Efficiency of Recovery Using a Novel Surgical Sponge-Blood Recovery Device (ProCell): Delayed Impact
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Units of Packed Red Blood Cells Transfused
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
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
Subjects will be blinded to the 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
Units of Packed Red Blood Cells Transfused
时间窗: Up to 72 Hours Post-Operative
Units of packed red blood cells transfused will be measured.
Change in Level of Hematocrit
时间窗: Baseline, Post-Operative Hours 0, 6, 12, 18, 24, 48, and 72
Level of hematocrit will be measured at baseline and post-operative.
Change in Level of Plasma Free Hemoglobin
时间窗: Baseline, Post-Operative Hours 0, 6, 12, 18, 24, 48, and 72
Level of plasma free hemoglobin will be measured at baseline and post-operative.
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.
次要结局
- Change in Number of Fragmented Red Blood Cells(Baseline, Post-Operative Hours 0, 6, 12, 18, 24, 48, and 72)
- Change in Level of Lactate Dehydrogenase(Baseline, Post-Operative Hours 0, 6, 12, 18, 24, 48, and 72)
- Change in Level of Haptoglobin(Baseline, Post-Operative Hours 0, 6, 12, 18, 24, 48, and 72)
- Time to Wring Sponges(Up to 120 Minutes)
- Change in Level of Bilirubin(Baseline, Post-Operative Hours 0, 6, 12, 18, 24, 48, and 72)
- Change in Weight of Surgical Sponge(Baseline, Post-Procedure (Up to 5 Minutes))