HaemoptysisNCT02816229
Endobronchial Valves in Inoperable Patients With Haemoptysis
A study testing Insertion of endobronchial valve in people with Haemoptysis, run by University of Stellenbosch.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Haemoptysis
- What is being tested?
- Insertion of endobronchial valve
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jan 2019to Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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)
Who cannot join
- Haemodynamic instability (defined as SBP< 90mmHg requiring ongoing fluid resuscitation or inotropic support)
- Patients necessitating mechanical ventilation because of respiratory failure or airway management
- Active tuberculosis
- High clinical suspicion of lung carcinoma
- Any other condition, which in the opinion of the investigators, places the subject at increased risk for bronchoscopy and EBV placement.
Trial locations and contacts
No sites are listed yet.
Brian Allwood, MBChB, PhD contact
About this study
Official title: Endobronchial Valves in Inoperable Patients With Life-threatening Haemoptysis Refractory to Bronchial Artery Embolisation
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.
Read the detailed description
Massive haemoptysis commonly occurs in patients who have had tuberculosis. While surgical resection of the affected lung segment can be curative, a large majority of patients may not qualify for surgical intervention for a number of reasons. This leaves them with few options to manage their haemoptysis.
Many patients at Tygerberg Hospital have severely reduced cardiopulmonary reserves secondary to multiple episodes of pulmonary Tuberculosis and often present either a unilateral largely destroyed lung or bilateral disease, which make them unsuitable for surgery. For these unfortunate patients who do not qualify for surgery or repeat BAE, practically no treatment options exist, and a significant proportion die in hospital or after discharge from a recurrent episode of massive haemoptysis. For these patients the only option may be to block the bleeding bronchus (identified by the previous BAE or during bronchoscopy) with a balloon catheter (Fogarty catheter) or placement of haemostatic gauze or gel. All these procedures are, however, of limited benefit. Using a blocking device which could be deployed and left in place permanently or be removed if needed has become a new therapeutic concept. Dutau and colleagues reported the successful use of the endoscopic placement of a silicone Spigot in a 39-year-old-woman with massive haemoptysis which prevented alveolar inundation preceding and during the time of bronchial artery embolisation.
Our institution has a long standing experience in massive haemoptysis, clinically and scientifically. We evaluate about 80-100 patients with life threatening haemoptysis a year. Furthermore, we were involved in an early emphysema trial using the IBVEBV® (Intra-Bronchial Valve) of Spiration and have, therefore, the necessary experience with the valve implantation technique.
No data are available regarding the potential clinical use of endobronchial valves in patients with recurrence of haemoptysis after BAE in patients who are not candidate for surgery or BAE.
This study aims to investigate the use, therapeutic benefit and safety of IBV Zephyr® valves in inoperable patients with haemoptysis not responding to BAE or in cases where BAE is not considered feasible.
This is a prospective randomised intervention-control study, with patients allocated to either best medical care (control) or endobronchial valve (intervention) groups. The valves will be inserted via flexible bronchoscopy into the affected lung regions. The primary outcome measure is the time to resolution of massive haemoptysis. Secondary outcomes will include physical and lung function and the occurrence of complications resulting from the insertion of the EBV.
Statistical analysis will be performed blinded to patient grouping by a statistician, and both univariate and multivariate analyses will be performed using the appropriate parametric and non-parametric tests. Appropriate tests for categorical data (e.g. Chi-squared test) and continuous data (e.g. Kruskal-Wallis, and ANOVA) will be used. Logistic and linear regression modelling will be used for certain outcomes, and multivariate analysis will be performed using stepwise regression modelling and full modelling where appropriate.
- Conditions
- Haemoptysis
- Being tested
- Insertion of endobronchial valve
- Keywords
- Haemoptysis, Aspergillus, Endobronchial valve, Interventional pulmonology, Tuberculosis
- Medical subject headings
- Hemoptysis, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insertion of endobronchial valveDevice
One or more endobronchial one- way valves will be inserted into the appropriate lung regions
| Study group | Role | What they receive |
|---|---|---|
| Insertion of endobronchial valve | Experimental | Patients in this group will have one or more EBV inserted into the relevant lung regions to manage the haemoptysis via flexible bronchoscopy. Receives: Device: Insertion of endobronchial valve |
| Best care | No intervention | Patients will receive best medical care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of termination of haemoptysis
Measured: 1 year
Secondary outcomes (5)
Time to recurrence of haemoptysis
Measured: 1 year
Improvement in exercise performance
Measured: 1 year
Improvement in lung function
Measured: 1 year
Recurrence of infection/tuberculsis
Measured: 1 year
EBV related complications
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study startJan 2019 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HaemoptysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Stellenbosch
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Brian Allwood, University of Stellenbosch
- Investigators
- Brian Allwood, MBChB, PhD, Study chair, University of Stellenbosch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02816229
- Sponsor's protocol ID
- N10/11/386
- Status last verified
- Oct 2018
- First submitted
- 23 Jun 2016
- Last updated
- 12 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
van den Heuvel MM, Els Z, Koegelenberg CF, Naidu KM, Bolliger CT, Diacon AH. Risk factors for recurrence of haemoptysis following bronchial artery embolisation for life-threatening haemoptysis. Int J Tuberc Lung Dis. 2007 Aug;11(8):909-14.
PubMed 17705959Gross AM, Diacon AH, van den Heuvel MM, Janse van Rensburg J, Harris D, Bolliger CT. Management of life-threatening haemoptysis in an area of high tuberculosis incidence. Int J Tuberc Lung Dis. 2009 Jul;13(7):875-80.
PubMed 19555538Freitag L, Tekolf E, Stamatis G, Montag M, Greschuchna D. Three years experience with a new balloon catheter for the management of haemoptysis. Eur Respir J. 1994 Nov;7(11):2033-7.
PubMed 7875278Dutau H, Palot A, Haas A, Decamps I, Durieux O. Endobronchial embolization with a silicone spigot as a temporary treatment for massive hemoptysis: a new bronchoscopic approach of the disease. Respiration. 2006;73(6):830-2. doi: 10.1159/000092954. Epub 2006 Apr 21.
PubMed 16636529
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endobronchial Valves in Inoperable Patients With Life-threatening Haemoptysis Refractory to Bronchial Artery Embolisation
- ClinicalTrials.gov ID
- NCT02816229
- Acronym / sponsor ID
- N10/11/386
- Conditions
- Haemoptysis
- Keywords
- Haemoptysis, Aspergillus, Endobronchial valve, Interventional pulmonology, Tuberculosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of StellenboschUniversity, hospital or other
- Study start
- Jan 2019 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 28 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Massive haemoptysis commonly occurs in patients who have had tuberculosis. While surgical resection of the affected lung segment can be curative, a large majority of patients may not qualify for surgical intervention for a number of reasons. This leaves them with few options to manage their haemoptysis.
Many patients at Tygerberg Hospital have severely reduced cardiopulmonary reserves secondary to multiple episodes of pulmonary Tuberculosis and often present either a unilateral largely destroyed lung or bilateral disease, which make them unsuitable for surgery. For these unfortunate patients who do not qualify for surgery or repeat BAE, practically no treatment options exist, and a significant proportion die in hospital or after discharge from a recurrent episode of massive haemoptysis. For these patients the only option may be to block the bleeding bronchus (identified by the previous BAE or during bronchoscopy) with a balloon catheter (Fogarty catheter) or placement of haemostatic gauze or gel. All these procedures are, however, of limited benefit. Using a blocking device which could be deployed and left in place permanently or be removed if needed has become a new therapeutic concept. Dutau and colleagues reported the successful use of the endoscopic placement of a silicone Spigot in a 39-year-old-woman with massive haemoptysis which prevented alveolar inundation preceding and during the time of bronchial artery embolisation.
Our institution has a long standing experience in massive haemoptysis, clinically and scientifically. We evaluate about 80-100 patients with life threatening haemoptysis a year. Furthermore, we were involved in an early emphysema trial using the IBVEBV® (Intra-Bronchial Valve) of Spiration and have, therefore, the necessary experience with the valve implantation technique.
No data are available regarding the potential clinical use of endobronchial valves in patients with recurrence of haemoptysis after BAE in patients who are not candidate for surgery or BAE.
This study aims to investigate the use, therapeutic benefit and safety of IBV Zephyr® valves in inoperable patients with haemoptysis not responding to BAE or in cases where BAE is not considered feasible.
This is a prospective randomised intervention-control study, with patients allocated to either best medical care (control) or endobronchial valve (intervention) groups. The valves will be inserted via flexible bronchoscopy into the affected lung regions. The primary outcome measure is the time to resolution of massive haemoptysis. Secondary outcomes will include physical and lung function and the occurrence of complications resulting from the insertion of the EBV.
Statistical analysis will be performed blinded to patient grouping by a statistician, and both univariate and multivariate analyses will be performed using the appropriate parametric and non-parametric tests. Appropriate tests for categorical data (e.g. Chi-squared test) and continuous data (e.g. Kruskal-Wallis, and ANOVA) will be used. Logistic and linear regression modelling will be used for certain outcomes, and multivariate analysis will be performed using stepwise regression modelling and full modelling where appropriate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insertion of endobronchial valve | Experimental | Device: Insertion of endobronchial valvePatients in this group will have one or more EBV inserted into the relevant lung regions to manage the haemoptysis via flexible bronchoscopy. |
| Best care | No intervention | –Patients will receive best medical care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥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*
Key exclusion criteria (5 listed)
- Haemodynamic instability (defined as SBP< 90mmHg requiring ongoing fluid resuscitation or inotropic support)
- Patients necessitating mechanical ventilation because of respiratory failure or airway management
- Active tuberculosis
- High clinical suspicion of lung carcinoma
- Any other condition, which in the opinion of the investigators, places the subject at increased risk for bronchoscopy and EBV placement.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insertion of endobronchial valveOne or more endobronchial one- way valves will be inserted into the appropriate lung regions | Device | Insertion of endobronchial valve |
Primary outcome
Rate of termination of haemoptysis
Time frame: 1 year
5 secondary outcomes
Time to recurrence of haemoptysis
Time frame: 1 year
Improvement in exercise performance
Time frame: 1 year
Improvement in lung function
Time frame: 1 year
Recurrence of infection/tuberculsis
Time frame: 1 year
EBV related complications
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2018.
- Background: PubMed 17705959van den Heuvel MM, Els Z, Koegelenberg CF, Naidu KM, Bolliger CT, Diacon AH. Risk factors for recurrence of haemoptysis following bronchial artery embolisation for life-threatening haemoptysis. Int J Tuberc Lung Dis. 2007 Aug;11(8):909-14.
- Background: PubMed 19555538Gross AM, Diacon AH, van den Heuvel MM, Janse van Rensburg J, Harris D, Bolliger CT. Management of life-threatening haemoptysis in an area of high tuberculosis incidence. Int J Tuberc Lung Dis. 2009 Jul;13(7):875-80.
- Background: PubMed 7875278Freitag L, Tekolf E, Stamatis G, Montag M, Greschuchna D. Three years experience with a new balloon catheter for the management of haemoptysis. Eur Respir J. 1994 Nov;7(11):2033-7.
- Background: PubMed 16636529Dutau H, Palot A, Haas A, Decamps I, Durieux O. Endobronchial embolization with a silicone spigot as a temporary treatment for massive hemoptysis: a new bronchoscopic approach of the disease. Respiration. 2006;73(6):830-2. doi: 10.1159/000092954. Epub 2006 Apr 21.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Allwood, MBChB, PhD contact
Brian Allwood, MBChB, PhD study chair
University of Stellenbosch
Questions about this trial
What is this clinical trial studying?
A study testing Insertion of endobronchial valve in people with Haemoptysis, run by University of Stellenbosch.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brian Allwood, MBChB, PhD (brianallwood@sun.ac.za), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of termination of haemoptysis (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02816229, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2018.