Development of a Thromboelastography-Based Algorithm for Targeted Bleeding Management in Open Heart Surgery: An In Vitro Clinical Study
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Serkan Uckun
- 入组人数
- 140
- 主要终点
- Targeted coagulation therapy
概览
简要总结
This study aims to develop an algorithm that can guide targeted bleeding management through thromboelastography (TEG) viscoelastic testing performed on blood samples from patients undergoing open heart surgery. The goal is to develop an algorithm that supports targeted bleeding management based on TEG parameters. The study is prospective, in vitro, and non-invasive. The material will consist of residual blood samples from open heart surgery patients. Analyses will be performed using TEG parameters (R time, K time, MA, LY30). Patients will be randomized using a closed-envelope method and divided into two groups: anesthesiologist standard clinical observation-control (Group K) and anesthesiologist standard clinical observation and TEG analysis (Group T). The sample size is 70 patients per group. From an ethical standpoint, this study uses anonymous data without additional blood collection and ensures patient safety.
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
- None
入排标准
- 年龄范围
- 18 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who will undergo open heart surgery
- •Patients who have given informed consent
排除标准
- •Patients undergoing emergency surgery
- •Patients with known congenital coagulation disorders
- •Patients with a known history of bleeding diathesis
- •Patients receiving uninterrupted anticoagulant therapy at an optimal time
- •Patients with renal failure under dialysis treatment
- •Patients with active malignancy
- •Patients who did not provide informed consent
研究组 & 干预措施
Control
The decision regarding blood and blood product transfusions will be made based on clinical observation by an anesthesiologist, which is our current routine practice.
Group T
Blood clotting tests are performed with the device.
干预措施: Blood Product (Diagnostic Test)
结局指标
主要结局
Targeted coagulation therapy
时间窗: A total of three measurements will be take After induction of anesthesia (Between 15 and 30 minutes of the operation) During cardiopulmonary bypass (2 hours after the start of surgery) Following cardiopulmonary bypass (4 hours after the start of surgery)
Measurement of R time using thromboelastography Measurement of K time using thromboelastography Measurement of maximum amplitude using thromboelastography
次要结局
- Use of blood products(Anesthesia continues during cardiopulmonary bypass exit (4 to 5 hours after surgery))
研究者
Serkan Uckun
assistant professor
Balikesir University