Response to Instillation of Activase in the Pleural Cavity vs Placebo in the Management of Complicated Pleural Effusion/Empyema
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- No Surgical Intervention
研究概览
简要总结
The purpose of this study is to document the efficacy and safety of intrapleural instillation of Activase vs Placebo in the management of complicated pleural effusions and empyemas
详细描述
The current treatments available for complicated pleural effusions (CPE) include chest tube placement for drainage and IV antibiotics. If this fails and CPE occurs then in most patients thoracotomy is performed. Patients that are not surgical candidates have image guided catheter placement performed, sometimes multiple times. The American College of Chest Physicians (ACCP) formed a CPE panel and published guidelines for treating CPE. Percutaneous image-guided drainage is the most common approach for CPE. The panel recognizes the cumulative data that supports the use of fibrinolytics, VATS, and thoracotomy. The CPE panel acknowledged the lack of randomized clinical trials to determine efficacy and safety of these modalities in CPE and strongly encourages the research to take place.
Fibrinolytic therapy is a relatively noninvasive, easy to use, and is relatively inexpensive. If successful, it will prevent sepsis and septic shock, decrease hospital stay, morbidity and mortality and prevent any surgical procedures. Multiple doses of fibrinolytics have been used in CPE with no evidence of systemic anti-fibrinolytic activity. Complications with these medications are also very uncommon and only isolated instances are reported. The benefit from successful pleural drainage using these agents will decrease morbidity, mortality, surgical procedures, and hospital stay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with complicated pleural effusions
- •Ability to provide written informed consent and comply with study assessments for the full duration of the study.
- •Age > 18 years
- •Exclusion Criteria
- •Current use of oral anticoagulants (e.g., warfarin sodium) with an International Normalized Ratio (INR) >5- Activated partial thromboplastin time (aPPT) > 80, Platelet count < 100,000/mm3;
- •Severe uncontrolled hypertension
- •Recognized hypersensitivity to Activase; or any component of its formulation; Traumatic pleural effusion
- •Pregnancy (positive pregnancy test)
- •In another study for this condition
- •Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
- •Participation in another simultaneous medical investigation
- •Recent stroke
- •Intracranial hemorrhage
- •arteriovenous malformation or aneurysm
- •Intracranial neoplasm
- •Acute myocardial infarction
- •Acute pulmonary embolus
排除标准
- 未提供
研究组 & 干预措施
Alteplase, Placebo- intapleural instillation
Either 25 mg of Alteplase or Placebo instilled daily. Response to therapy after three days. cross over to the other drug if no response was noted.
干预措施: Alteplase (Drug)
Alteplase, Placebo- intapleural instillation
Either 25 mg of Alteplase or Placebo instilled daily. Response to therapy after three days. cross over to the other drug if no response was noted.
干预措施: Placebo (Drug)
Placebo, Alteplase -2nd arm
If the first arm fails then the 2nd arm ( cross over to either Placebo or Alteplase not used in the first arm) instilled intrapleurally daily for three days
干预措施: Alteplase (Drug)
Placebo, Alteplase -2nd arm
If the first arm fails then the 2nd arm ( cross over to either Placebo or Alteplase not used in the first arm) instilled intrapleurally daily for three days
干预措施: Placebo (Drug)
结局指标
主要结局
No Surgical Intervention
时间窗: patients were followed six weeks per protocol. Most patients treated with Alteplase were also followed for up to six months
CT scans of the chest and Chest X rays (CXR) were used to determine resolution of Pleural effusions/empyema/ pneumonia after 3 days of Alteplase/ Placebo therapy. If no response was noted with the first intervention patients were offered surgery --Decortiation/ Video Assisted Thoracic Surgery (VATS) or to receive the second intervention. Patients that failed the second intervention were offered surgery.
次要结局
- Number of Participants With Pneumonia That Responded to Therapy(6 weeks)
- Number of Participants With Pleural Effusion/Empyema That Responded to Therapy(6 weeks)
- Number of Participants With Shortness of Breath That Responded to Therapy(6 weeks)
- Number of Participants With Clinical Symptoms of Sepsis That Responded to Therapy(6 weeks)
研究者
GEORGE THOMMI
MD
Midwest Pulmonary and Critical Care
