Persistent Pleural Effusion Treatment Following Cardiothoracic Surgery by Platelet-Fibrin Glue: A Clinical Trail
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- The rate of air leak that is assessed by Cerfolio classification of the air leak by a single observer
研究概览
简要总结
Persistent pleural effusion is a life-threatening complication after cardiac surgery. The traditional treatment is chest tube drainage, which may not respond to treatment. This study introduces a new noninvasive approach for treating persistent pleural effusion using platelet-rich plasma fibrin glue (PRP-FG). This method has been successfully applied for the treatment of postoperative persistent chylothorax and pneumothorax in previous studies, which significantly decreased morbidity, mortality, and hospital stay.
详细描述
This pilot clinical trial recruited 19 patients at Imam Reza Hospital in Mashhad, Iran (2023) who had developed unilateral or bilateral refractory postoperative effusion resistant to conventional thoracostomy treatment. Treatment success was defined as effusion <50 ml/day after 48 hours, along with symptomatic improvement and no adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of pleural effusion after cardiac surgery in open-heart surgery
- •patients who sign an informed consent form
排除标准
- •Hemodynamically unstable patients
- •Patients who did not sign an informed consent form
研究组 & 干预措施
patients referred to the cardiac surgery clinic
This clinical trial focused on patients referred to the cardiac surgery clinic of Imam Reza Hospital in Mashhad 2023 who were diagnosed with unilateral or bilateral pleural effusion resistant to conservative management.
干预措施: Platelet-Rich Plasma and Fibrin Glue (Drug)
结局指标
主要结局
The rate of air leak that is assessed by Cerfolio classification of the air leak by a single observer
时间窗: within 48 hours after application of platelet-rich plasma
Continuous: Air leak is Present throughout the respiratory cycle Inspiratory: Present during the inspiration phase of the respiratory cycle. Expiratory: Present only during the expiratory phase of the respiratory cycle Forced expiration: Present only when the patient coughs or forces exhalation.
The number of injections until the bubble stops
时间窗: Through study completion, an average of 40 weeks
PRP-FG (5-7 ml/ kg) was injected into the pleural space through the chest tube.
Patient hospitalization time
时间窗: From the time the patient is admitted to the hospital to the time of discharge
Duration of the patient's stay in hospital, assessed up to 40 weeks
Percentage of patients completely recovered
时间窗: Through study completion, an average of 40 weeks
The treatment was successful if the bubbling was stopped and lung expansion was done.
Rate of radiolucency
时间窗: within 48 hours after application of platelet-rich plasma
The percent area on chest x-ray is almost completely transparent to radiation.
Percentage of untreated patients who died
时间窗: Through study completion, an average of 40 weeks
The bubbling was not stopped, lung expansion was not done and the patient was expired
次要结局
未报告次要终点
研究者
Daryoush Hamidi Alamdari, PhD
Associate professor
Mashhad University of Medical Sciences