Treatment Trials

13 Clinical Trials for Various Conditions

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RECRUITING
Chest Drain Regular Flushing in Complicated Parapneumonic Effusions and Empyemas
Description

Infections of the pleural space are common, and patients require antibiotics and chest drain placement to evacuate the chest from the infected fluid. Chest drains can get blocked by the drainage fluid and material. For this reason, it is thought that flushing the chest drain with saline solution, can help maintain the patency of the tube. This proposed study will evaluate the impact of regular chest drain flushing on the length of time to chest tube removal and total hospitalization as well as improvement in chest imaging and the need for additional interventions on the infected space.

WITHDRAWN
Empyema Treated With tPA & DNAse
Description

The objective of this study is to scientifically evaluate a new substrate for fibrinolysis compared to our standard tPA. The hypothesis, driven by a recent prospective trial, is that tPA may benefit from the addition of DNAse. The primary outcome variable between the two techniques will be length of hospitalization after initiation of treatment.

Conditions
COMPLETED
Efficacy and Safety of Activase (Ateplase) vs Placebo in Complicated Pleural Effusions (CPE)/Empyemas
Description

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

COMPLETED
Thoracoscopy Versus Fibrinolysis in Children With Empyema
Description

The null hypothesis is that patients receiving either thoracoscopy or fibrinolysis for empyema recover in the same amount of time. Therefore, we will test this by randomizing the next 40 patients who consent to the study to one treatment or the other.

Conditions
UNKNOWN
Alteplase for Treatment of Empyema and Complicated Parapneumonic Effusion
Description

The purpose of this study is to assess the benefit to patients with empyema or complicated parapneumonic effusion (CPE) using a daily versus twice daily Alteplase regimen of two different dose strategies compared with saline placebo.

RECRUITING
Pleural Space Saline Irrigation in Addition to Standard Intrapleural Thrombolytic Therapy in Empyema/Complicated Parapneumonic Effusion
Description

The purpose of this study is to see if there is any benefit in adding saline irrigation through a chest tube to the standard course of treatment for people diagnosed or suspected of having a pleural space infection.

COMPLETED
Management of Pleural Space Infections
Description

Currently, there is no high-quality evidence comparing the clinical outcomes and cost effectiveness of surgical drainage combined with antibiotics versus dual-agent intrapleural fibrinolytic therapy (IPFT) catheter drainage of pleural space infections with concomitant antibiotic therapy. The absence of comparative data is a challenge for surgical and medical services in clinical decision-making for this common and morbid condition. This is a pilot study comparing surgical drainage of the pleural space in complex pleural effusions to bedside chest tube drainage using dual agent IPFT with the intent to inform on study algorithm and endpoint performance in anticipation of a multi-institutional randomized clinical trial.

RECRUITING
UNC Pleural Fluid Registry
Description

Research with biospecimens such as blood, tissue, or body fluids can help researchers understand how the human body works. Researchers can make new tests to find diseases, understand how treatments work, or find new ways to treat a disease. The purpose of this study is to collect biospecimens for research from patients with known or suspected lung cancer. The information learned from the biospecimens may be used in future treatments. The purpose of this protocol is to create a pleural fluid registry for use in future studies.

COMPLETED
Fibrinolysis Compared to Thoracoscopy for Pleural Infection
Description

The purpose of this prospective randomized clinical trial is to compare two currently accepted standard-of-care treatment strategies: Medical thoracoscopy as compared to instillation of intrapleural tissue Plasminogen Activator (TPA) and human recombinant Deoxyribonuclease (DNase) for the management of empyema or complicated parapneumonic effusion (CPPE) in adults.

COMPLETED
Prospective Evaluation of 14F Thal Tube vs 28 French Chest Tube for Hemothorax and Use of Maximum Barrier Precautions
Description

Traumatic hemothorax and hemopneumothorax are common diagnoses which are typically treated by placement of a chest tube. 28-32 Fr chest tubes have previously been shown equivalent to 36-40 Fr chest tubes for the non-emergent drainage of hemothorax. A smaller study has found 14 Fr pigtails had less pain than larger tubes but was not powered to compare outcomes. We seek to perform a prospective randomized trial that is adequately powered comparing efficacy of 14 Fr thal tubes to 28 Fr chest tubes for non-emergent drainage of hemothorax and hemopneumothorax. Additionally, we will employ maximal barrier precautions for all chest tube insertions and compare empyema rates to our historical controls.

TERMINATED
Comparing Xperguide vs. Conventional Methods During Percutaneous Image Guided Procedures
Description

Background: - Procedures that use medical tools in or near a possible abnormality in the body often use computed tomography (CT) scans to locate the abnormality and guide the path that a needle will take to collect a sample of tissue. Xperguide and electromagnetic (EM) tracking are two new procedures being studied to help guide the needle. Xperguide is software that uses CT images to help the doctor choose the needle path. EM tracking uses special medical tools with miniature coils that act like a Global Positioning Satellite (GPS) device to show the location of the needle in the body. Xperguide and EM tracking have been used in humans and have good results, but they have not been compared with each other and regular CT to determine whether they are better than the standard approach. Objectives: - To compare the results of Xperguide, electromagnetic tracking, and regular computed tomography during a guided percutaneous procedure. Eligibility: - Individuals at least 18 years of age who are required to have a CT-guided percutaneous procedure. Design: * Participants will be screened with a physical examination and medical history, and the results of any previous imaging studies will be examined before study enrollment. * After a pilot phase, the study will involve two phases to compare the results of the different procedures. The first phase will involve comparing Xperguide to CT, and the second will involve comparing Xperguide to EM tracking. * Phase 1 participants will be assigned to one of two procedure groups: Group 1 will have Xperguide, and Group 2 will have regular CT. Participants who are scheduled to have repeated procedures (like a biopsy before and after chemotherapy) will be randomized for the first procedure and the second procedure will be done using the other method. * Phase 2 participants will be assigned to one of two procedure groups: Group 1 will have Xperguide, and Group 2 will have EM tracking. Participants who are scheduled to have repeated procedures (like a biopsy before and after chemotherapy) will be randomized for the first procedure and the second procedure will be done using the other method. * Standard post-procedure followup care will be given after the study procedure is completed.

COMPLETED
The Role of Surgery in Patients With Coronavirus Disease - 19 (COVID-19) Related Thoracic Complications
Description

Thoracic complications directly or indirectly consequence of Coronavirus Disease 2019 (COVID-19) (including either pathologies strictly related to the infection, or iatrogenic effects of therapeutic attempts to treat it) have been described during the pandemic. Many of the above conditions often require a surgical approach but, based on published data reporting high early postoperative morbidity and mortality, many experts initially advised against any referral to surgery in COVID-19 patients. Therefore, the issue is if salvage surgical approach should be always excluded or could be considered when it represents the only remaining effective option. In the absence of solid data and recommendations, this is a demanding challenge for thoracic surgeons. The investigators have coordinated a multicenter study to collect the experience of several worldwide high-volume thoracic surgery departments. Their objective is to investigate efficacy and safety of surgery in COVID-19 patients who developed thoracic complications that required operative management.

COMPLETED
Treatment of Complicated Parapneumonic Effusion With Fibrinolytic Therapy Versus VATs Decortication
Description

This study aims to standardize the treatment of pleural space (parapneumonic) infections by comparing the difference in outcomes between 2 methods of treatment: early VATS (Video Assisted Thorascopic Surgery) decortication versus fibrinolytic therapy. During treatment, the patient's coagulopathy status will also be evaluated.