Prolonged Air LeakPhase 3NCT02491671

Effectiveness Novel Tissue Sealant, Prevention Prolonged Air Leak (PAL) After Lung Resection

A Phase 3 study testing Hemopatch and standard preventive measures in people with Prolonged Air Leak and Lung Resection, run by Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León at 6 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Prolonged Air Leak, Lung Resection
What is being tested?: Hemopatch and standard preventive measures
Type of treatment: Injection or infusion, Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 260 participants
Where: 6 sitesSpain
Study dates: 24 Nov 2015to 30 Jun 2019
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Scheduled anatomical lung resection indicated for any non-infectious disease (excluding Pneumonectomy)
Patients classified in class D according estimated risk of PAL
Age between 18 and 80 years

Who cannot join

Those patients that according to Investigator assessment are not going to tolerate the procedure
Clinical and anesthetic criteria that contraindicate surgery
Severe uncontrolled illness
Pregnancy
Patients that are under Investigational New Drug treatment or have participated in study with a investigational drug (authorized or not) in 30 days before randomization.
Lack of Informed Consent or patient refusal
Postsurgery mechanical ventilation or repeated surgery in follow-up month.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

Spain6 sites

Hospital Clinic
Barcelona, 08036
Hospital Universitario Ramón y Cajal de Madrid
Madrid, 28034
Hospital Clínico San Carlos
Madrid, 28040
Hospital Universitario de Salamanca (CAUSA)
Salamanca, 37007
Hospital Universitario Marqués de Valdecilla de Santander
Santander, Cantabria, 39008
Hospital Universitario Virgen del Rocío
Seville, 41013

Other trials in Spain

About this study

Official title: Prospective, Multicenter, Open-Label, Randomized, Phase III Clinical Trial of Prevention of Prolonged Air Leak After Lung Resection in High-risk Patients, Applying HEMOPATCH®

The effectiveness of tissue sealants to prevent Prolonged Air Leak (PAL) after lung resection procedures remains unproved. The investigators hypothesize that one of the main reasons for that is the heterogeneity of previously studied populations. Since currently the risk of postoperative PAL can be scored with a reasonable accuracy, the aim of this research is to investigate the effect of routine application of a novel tissue sealant in patients selected on the basis of a high risk of PAL estimated before surgery.

Conditions: Prolonged Air Leak, Lung Resection
Being tested: Hemopatch, standard preventive measures
Keywords: Prevention PAL Prolonged Air Leak (PAL), Lung Resection, Thoracic Surgery, Post-operative Thoracic Air Leak

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HemopatchDevice
standard preventive measuresProcedure or surgery

Study groups in NCT02491671
Study group	Role	What they receive
Experimental group	Experimental	Experimental group: At the end of lung resection, lung sutures and 1.5 cm of lung parenchyma on each side will be covered by Hemopatch. No additional measures for preventing air leak will be indicated. In the case of massive air leak in spite of the use of Hemopatch, each surgeon will decide on the indication of additional sutures of tissue plasties. These cases will be accounted for failures on an intention to treat basis. Receives: Device: Hemopatch; Procedure: standard preventive measures
Control group	Other	Control group: The standard preventive measures will be followed in each center, including reinforcement of sutures, pleural tents, suturing pericardial or subcutaneous fat Receives: Procedure: standard preventive measures

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Prolonged Air Leak (PAL)
Prevalence of Prolonged Air Leak (PAL) measured as binary variable (YES/NO) and recorded, from day of surgery to the fifth postoperative day, in the study questionnaire. The occurrence of the outcome will be recorded if air leak exists 5 days or more after surgery
Measured: From day of surgery to the fifth postoperative day

Secondary outcomes (3)

Duration of Air Leaks
Measured as continuous variable (days) and recorded, from day of surgery to the day of withdraw the chest tube. (standardized criteria for pulling out chest drainage/s will be agreed among investigators)
Measured: Check everyday from day of surgery up to 38 days post-operative at maximum
Number of Participants With at Least One Chest Tube Reinsertion
Rate of patients needing postoperative reinsertion of chest drainages due to symptomatic pneumothorax. Following daily during hospital stay and pone follow-up until 30th day post-operative.
Measured: From day of surgery up to 30 days thereafter
Number of Participants With One or More Readmission
Rate of readmissions due to relapsing pneumothorax (follow-up 30 days)
Measured: 30 days post-operative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Nov 201530 Jun 2019

First posted8 Jul 2015 (estimated)
Study start24 Nov 2015
Primary completion30 Jun 2019
Study completion30 Jun 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Prolonged Air LeakStudies 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 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 260 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02491671
Sponsor's protocol ID: HEMOPATCH/FAP/2014
Status last verified: Aug 2021
First submitted: 10 Jun 2015
Last updated: 9 Aug 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
A Study Comparing ETHICON™ 4000 Stapler System With Standard of Care Stapling Devices in Adults Undergoing Gastric and Thoracic Procedures
Surgical Procedures, Operative
Enrolling by invitation
Prolonged Air Leak (PAL) Autologous Blood Patch Intervention Trial
Lung Cancer
Recruiting
Comparison of 40% Glucose Solution and Autologous Blood Patch Pleurodesis for Postoperative Air Leak After Lung Resections
Prolonged Air Leak, Persistent Air Leak
Not yet recruitingPhase 1
Reinforced and Non-Reinforced Staple Lines in Fissureless Lobectomy
Lung, Lung Adenocarcinoma

All Prolonged Air Leak trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective, Multicenter, Open-Label, Randomized, Phase III Clinical Trial of Prevention of Prolonged Air Leak After Lung Resection in High-risk Patients, Applying HEMOPATCH®
ClinicalTrials.gov ID: NCT02491671
Acronym / sponsor ID: HEMOPATCH/FAP/2014
Conditions: Prolonged Air Leak, Lung Resection
Keywords: Prevention PAL Prolonged Air Leak (PAL), Lung Resection, Thoracic Surgery, Post-operative Thoracic Air Leak
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 260 participants (actual)
Lead sponsor: Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y LeónUniversity, hospital or other
Collaborators: Instituto de Investigación Biomédica de Salamanca, Baxter Healthcare Corporation
Study start: 24 Nov 2015 (actual)
Primary completion: 30 Jun 2019 (actual)
Study completion: 30 Jun 2019 (actual)
First posted: 8 Jul 2015 (estimated)
Results: Posted 27 Jul 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Experimental group	Experimental	Device: Hemopatch, Procedure: standard preventive measuresExperimental group: At the end of lung resection, lung sutures and 1.5 cm of lung parenchyma on each side will be covered by Hemopatch. No additional measures for preventing air leak will be indicated. In the case of massive air leak in spite of the use of Hemopatch, each surgeon will decide on the indication of additional sutures of tissue plasties. These cases will be accounted for failures on an intention to treat basis.
Control group	Other	Procedure: standard preventive measuresControl group: The standard preventive measures will be followed in each center, including reinforcement of sutures, pleural tents, suturing pericardial or subcutaneous fat

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Scheduled anatomical lung resection indicated for any non-infectious disease (excluding Pneumonectomy)
Patients classified in class D according estimated risk of PAL
Age between 18 and 80 years

Key exclusion criteria (7 listed)

Those patients that according to Investigator assessment are not going to tolerate the procedure
Clinical and anesthetic criteria that contraindicate surgery
Severe uncontrolled illness
Pregnancy
Patients that are under Investigational New Drug treatment or have participated in study with a investigational drug (authorized or not) in 30 days before randomization.

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
Hemopatch	Device	Experimental group
standard preventive measures	Procedure or surgery	Control group, Experimental group

Primary outcome

Number of Participants With Prolonged Air Leak (PAL)
Time frame: From day of surgery to the fifth postoperative day
Prevalence of Prolonged Air Leak (PAL) measured as binary variable (YES/NO) and recorded, from day of surgery to the fifth postoperative day, in the study questionnaire. The occurrence of the outcome will be recorded if air leak exists 5 days or more after surgery

3 secondary outcomes

Duration of Air Leaks
Time frame: Check everyday from day of surgery up to 38 days post-operative at maximum
Number of Participants With at Least One Chest Tube Reinsertion
Time frame: From day of surgery up to 30 days thereafter
Number of Participants With One or More Readmission
Time frame: 30 days post-operative

Results and safety

Results posted to the registry on 27 Jul 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Experimental Group	129	118
Control Group	131	118

Primary outcome: Number of Participants With Prolonged Air Leak (PAL)

Time frame: From day of surgery to the fifth postoperative day. Count of participants. Unit: Participants

Measure	Experimental Group n = 118	Control Group n = 118
Value	33	24

Experimental Group vs Control Group: Risk Ratio (RR): 1.219 (95% CI 0.891 to 1.583), p = 0.171, Chi-squared

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Through study completion, a total of up to 3 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Experimental Group	3 of 118 (2.5%)	0 of 118 (0%)	0 of 118
Control Group	7 of 118 (5.9%)	0 of 118 (0%)	2 of 118

Limitations and caveats (from the sponsor): Only the population in which a very high rate of PAL is expected was enrolled. There was no stratification by lung function or type of lung resection.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Prolonged Air Leak

Not yet recruiting
A Study Comparing ETHICON™ 4000 Stapler System With Standard of Care Stapling Devices in Adults Undergoing Gastric and Thoracic Procedures
Surgical Procedures, Operative
Enrolling by invitation
Prolonged Air Leak (PAL) Autologous Blood Patch Intervention Trial
Lung Cancer
Recruiting
Comparison of 40% Glucose Solution and Autologous Blood Patch Pleurodesis for Postoperative Air Leak After Lung Resections
Prolonged Air Leak, Persistent Air Leak
Not yet recruitingPhase 1
Reinforced and Non-Reinforced Staple Lines in Fissureless Lobectomy
Lung, Lung Adenocarcinoma

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.

Gonzalo Varela, MD PhD FETCS study director

IBSAL-Instituto de Investigación Biomédica de Salamanca

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 7 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: finished, as of the sponsor's last update on 9 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Prolonged Air Leak (PAL) (time frame: From day of surgery to the fifth postoperative day). 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 NCT02491671.

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 9 Aug 2021.