Intrapleural Catheter Daily Versus Three Times a Week Drainage (NCT00761618) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Intrapleural Catheter Daily Versus Three Times a Week Drainage
United States257 participantsStarted 2008-08-22
Plain-language summary
The goal of this clinical research study is to learn if draining the IPC every day is better at than draining it 3 times a week.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients with symptomatic pleural effusion requiring placement of an IPC.
. Signed informed consent prior to any study related procedures.
. Subject must be age 18 years or over.
Exclusion criteria
. Any of the following interventions on the affected hemithorax: prior IPC, prior chest tube placement, history of chemical or mechanical pleurodesis, history of thoracotomy within 4 weeks incompletely healed surgical incision before randomization.
. Evidence of empyema or history of empyema of the affected hemithorax
. Non-correctable bleeding diathesis
. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
. Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the Principal Investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol.
. Participation in any clinical trial that prevents randomization of the subject to either strategy.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time to Pleurodesis (TTP)
Timeframe: 2 weeks after intrapleural catheter placement
. Clinical evidence of skin infection at the potential site of IPC placement.
. Current or prior IPC placement, or any intervention to manage recurrent malignant pleural effusion on the contralateral hemithorax (excluding thoracentesis).