A double blind randomized cross over trial comparing rate of decortication and efficacy of intrapleural instillation of alteplase vs placebo in patients with empyemas and complicated parapneumonic effusions

• Published in: Respiratory medicine 2012-05, Vol.106 (5), p.716-723
• Main Authors: Thommi, G, Shehan, J.C, Robison, K.L, Christensen, M, Backemeyer, L.A, McLeay, M.T
• Format: Article
• Language: English
• Subjects: Adult; Aged; Aged, 80 and over; Alteplase; Bacterial diseases; Bacterial diseases of the respiratory system; Biological and medical sciences; Bleeding; Chest; Clinical trials; Computed tomography; CPE (complicated parapneumonic effusion); Double-Blind Method; Drug Administration Schedule; Drugs; Effusion; Empyema; Empyema, Pleural - diagnostic imaging; Empyema, Pleural - drug therapy; Empyema, Pleural - etiology; Empyema, Pleural - surgery; Female; Fibrinolytic Agents - administration & dosage; Fibrinolytic Agents - adverse effects; Fibrinolytic Agents - therapeutic use; Human bacterial diseases; Humans; Infectious diseases; Male; Medical sciences; Middle Aged; Pain; Pleural effusion; Pleural Effusion - diagnostic imaging; Pleural Effusion - drug therapy; Pleural Effusion - etiology; Pleural Effusion - surgery; Pneumology; Pneumonia - complications; Pulmonary/Respiratory; Side effects; Statistical analysis; Surgery; Thrombolytic Therapy - adverse effects; Thrombolytic Therapy - methods; Tissue plaminogen activator (tPA); Tissue Plasminogen Activator - administration & dosage; Tissue Plasminogen Activator - adverse effects; Tissue Plasminogen Activator - therapeutic use; Tomography, X-Ray Computed; Treatment Outcome; Young Adult
• ISSN: 0954-6111; 1532-3064
• DOI: 10.1016/j.rmed.2012.02.005

Summary Aim A double blind randomized cross over trial to compare the rate of decortication, safety and efficacy of intrapleural instillation of Alteplase vs. Placebo in empyema and complicated parapneumonic effusions (CPE). Methods Patients diagnosed with empyema or CPE and considered for surgery were given the option to enter into this trial. Intrapleural instillation of the ‘Drug’ was given daily for three days. Patient that failed the first arm of the trial were offered surgery or to cross over to the second arm. Failure was documented if pleural effusions did not improve by 50% on CT scans after three doses of the ‘Drug’ or if these effusions recurred within six weeks. Results One hundred and eight patients were evaluated and one hundred enrolled in the trial. 32 patients were excluded, 29 for noninfectious loculated effusions, two for protocol violation and one for bleeding at chest tube site. There were 17 patients with empyema and 51 patients with CPE. 58 of the 61 patients (26 crossed over) with empyema/CPE resolved with Alteplase therapy compared to 4 of the 32 patients (one crossed over) treated with Placebo ( p value