Endobronchial Valves in Inoperable Patients With Haemoptysis (NCT02816229) | Clinical Trial Compass
UnknownNot Applicable
Endobronchial Valves in Inoperable Patients With Haemoptysis
20 participantsStarted 2019-01
Plain-language summary
Massive haemoptysis is a life-threatening condition which is commonly seen in patients who have previously had pulmonary tuberculosis. Various treatment options exist such as bronchial artery embolisation (BAE) or surgical resection of the affect lung region. However, BAE is not considered curative as there is often recurrence of haemoptysis. Furthermore, not all patients will be deemed suitable for surgical resection, leaving them with very few treatment options. A possible alternative intervention is the insertion of an endobronchial valve (EBV). It is speculated that blood will collect distal to the one way valve and a thrombus will be formed. There is currently no data describing the use of EBV for the treatment of massive haemoptysis. This RCT aims to explore the use and efficacy of EBV in the management of massive haemoptysis.
Who can participate
Age range
18 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* ≥18 years of age
* Written informed consent
* Current or previously documented admission to hospital with large volume haemoptysis (\>200ml/24hour); or haemoptysis with haemodynamic compromise (SBP \< 100mmHg for 15 minutes) or requiring fluid resuscitation; haemoptysis requiring intubation or deemed life-threatening by attending clinicians.
* The cause of haemoptysis must be due to severe underlying lung destruction/ bronchiectasis, post-tuberculous lung damage or the presence of an aspergillomata.
* Primary bronchial artery embolisation not considered technically possible\* or failed (defined as ongoing haemoptysis of at least 100 ml per day for 7 days or more, cumulative blood loss of \> 200 ml / 24 hours, or any volume resulting in a systolic blood pressure \< 100 mmHg for 15 minutes or necessitating resuscitation with vasopressors during a period of 30 days after BAE) and repeat BAE not considered feasible\*
* Lung resection not possible because of poor cardiopulmonary reserves (as defined by the current ERS/ESTS clinical guidelines28, independently reviewed by a team of consisting of a thoracic surgeon, pulmonologist and anaesthesiologist who will need to in absolute agreement on inoperability and/or lack of cardiopulmonary reserve)
Exclusion Criteria:
* Haemodynamic instability (defined as SBP\< 90mmHg requiring ongoing fluid resuscitation or inotropic support)
* Patients necessitating mechanical ventilation because of respiratory failure or ai…
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.