Air Leak From LungNCT03450265
Hemopatch Compared to TachoSil in Postoperative Air Leak Duration After Pulmonary Resection
A study testing Hemopatch and Tachosil in people with Air Leak From Lung, run by Baxter Healthcare Corporation at 14 sites in 2 countries.
Trial summary
This study is a randomized, controlled study, with the primary objective to demonstrate non-inferiority of Hemopatch compared to TachoSil in postoperative air leak duration after pulmonary resection, and with the secondary objective of evaluating the safety of Hemopatch compared to TachoSil. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Air Leak From Lung
- What is being tested?
- Hemopatch and Tachosil
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 279 participants
- Where
- 14 sitesin 2 countries
- Study dates
- 26 Jun 2018to 9 Jul 2019
- 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
- Preoperative-
- Patients, 18 years or older at the time of signing the informed consent form (ICF), undergoing elective pulmonary resections (lobectomy, segmentectomy, or wedge resection), either through open thoracotomy or through Visually Assisted Thoracotomy surgery (VATS)
- Patients or legally authorized representatives, who are able to give IC after an explanation of the proposed study, and who are willing to comply with the study requirements for therapy during the entire study treatment period
- If female of child-bearing potential, patient will present with a negative blood/urine pregnancy test, and will agree to employ adequate birth control measures for the duration of the study
- Intraoperative-
- Patients with grade 1 or 2 (Macchiarini scale) air leakage after primary stapling and limited suturing
Who cannot join
- Preoperative-
- Patients who had previous lung surgery (on the same side)
- Patients with an active, florid infection
- Patients who have received chemotherapy within the previous 3 weeks.
- Patients who have received radiation therapy within the previous 4 weeks.
- Patients with known hypersensitivity to the components of the investigational product and control (human fibrinogen, human thrombin, collagen of any origin, NHS-PEG)
Show all 17Show fewer
- Patients undergoing emergency surgery
- Female patients of childbearing potential with a positive pregnancy test or intent to become pregnant during the clinical study period
- Female patients who are nursing
- Patients with exposure to another investigational drug or device clinical trial within 30 days prior to enrollment or anticipated in the 30 day study period till the End of study visit.
- Patient has a clinically significant concurrent medical condition (e.g. concomitant illness, drug/alcohol abuse) that, in the opinion of the investigator, could adversely affect patient's safety and/or compliance with study procedures
- Patient is a family member or employee of the investigator
- Intraoperative-
- Patients with serious complications during surgery, including the need for adhesiolysis, and pneumonectomy.
- Patients who were treated with any surgical sealant
- Major intraoperative complications that require resuscitation or deviation from the planned surgical procedure
- Patients with any other intraoperative findings identified by the surgeon that may preclude the conduct of the study procedure
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
Italy7 sites
Baxter Investigational Site
Catania, 95123
Baxter Investigational Site
Milan, 20141
Baxter Investigational Site
Padova, 35128
Baxter Investigational Site
Pisa, 56124
Baxter Investigational Site
Rome, 144
Baxter Investigational Site
Rome, 151
Baxter Investigational Site
Rome, 168
Spain7 sites
Baxter Investigational Site
Alzira, Valencia, 46600
Baxter Investigational Site
Madrid, Getafe, 28905
Baxter Investigational Site
Madrid, Madrid, 28006
Baxter Investigational Site
Madrid, Madrid, 28040
Baxter Investigational Site
Madrid, Madrid, 28933
Baxter Investigational Site
Madrid, 28046
Baxter Investigational Site
Seville, Andalusia, 41009
About this study
Official title: A Randomized, Controlled, Non-inferiority Study to Evaluate the Efficacy and Safety of Hemopatch Compared to TachoSil in Preventing or Reducing Postoperative Air Leaks After Pulmonary Resection
This study is a randomized, controlled study, with the primary objective to demonstrate non-inferiority of Hemopatch compared to TachoSil in postoperative air leak duration after pulmonary resection, and with the secondary objective of evaluating the safety of Hemopatch compared to TachoSil.
- Conditions
- Air Leak From Lung
- Being tested
- Hemopatch, Tachosil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemopatchDevice
Applied according to the current instruction for use (IFU). According to the IFU, a maximum of 7 Hemopatch 45 x 90 mm patches can be used in adults.
TachosilDevice
Applied according to the current instruction for use (IFU).
| Study group | Role | What they receive |
|---|---|---|
| Hemopatch | Experimental | Patients undergo elective pulmonary resection. Following resection, primary stapling and suturing will be done and air leakage will be assessed. If a specific grade-level of air leakage is present, patients will be randomized and either Hemopatch or TachoSil applied. Receives: Device: Hemopatch |
| TachoSil | Active comparator | Patients undergo elective pulmonary resection. Following resection, primary stapling and suturing will be done and air leakage will be assessed. If a specific grade-level of air leakage is present, patients will be randomized and either Hemopatch or TachoSil applied. Receives: Device: Tachosil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of postoperative air leakage
Measured: Day 1 to Day 30
Secondary outcomes (9)
Incidence of intraoperative treatment failure
Measured: Day 1
Incidence of patients with prolonged air leakage defined as air leakage > 5 Days
Measured: Day 5 to Day 30
Number of additional procedures needed
Type of procedures include chest drainage, re-operation, respiratory assistance, and blood transfusion
Measured: Day 1 to Day 30
Time to chest tube removal
Measured: Day 1 to Day 30
Time in surgery (minutes) from incision to closure
Measured: Day 1
Length of stay in hospital (days)
Measured: Day 1 to Day 30
Number of unplanned interventions
Measured: Day 1 to Day 30
Incidence of pre-defined postoperative Adverse Events of Special Interest (AESIs)
Pre-defined AEs include Pneumothorax, Bronchopleural fistula, Emphysema (subcutaneous and mediastinal), Pleural effusions, Postoperative respiratory failure, Empyema, Allergic reactions in reasonable temporal relationship with the product application
Measured: Day 1 to Day 30
Number of patches used intra-operatively
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start26 Jun 2018
- Primary completion9 Jul 2019
- Study completion9 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Air Leak From LungStudies 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
- Participant
- Enrolment
- 279 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxter Healthcare Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03450265
- Sponsor's protocol ID
- BXU513667
- Other IDs
- 2017-003931-12, 2017
- Status last verified
- Apr 2020
- First submitted
- 13 Feb 2018
- Last updated
- 6 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Non-inferiority Study to Evaluate the Efficacy and Safety of Hemopatch Compared to TachoSil in Preventing or Reducing Postoperative Air Leaks After Pulmonary Resection
- ClinicalTrials.gov ID
- NCT03450265
- Acronym / sponsor ID
- BXU513667
- Conditions
- Air Leak From Lung
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 279 participants (actual)
- Lead sponsor
- Baxter Healthcare CorporationIndustry (pharma, biotech, devices)
- Study start
- 26 Jun 2018 (actual)
- Primary completion
- 9 Jul 2019 (actual)
- Study completion
- 9 Jul 2019 (actual)
- First posted
- 1 Mar 2018 (actual)
- 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.
This study is a randomized, controlled study, with the primary objective to demonstrate non-inferiority of Hemopatch compared to TachoSil in postoperative air leak duration after pulmonary resection, and with the secondary objective of evaluating the safety of Hemopatch compared to TachoSil.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemopatch | Experimental | Device: HemopatchPatients undergo elective pulmonary resection. Following resection, primary stapling and suturing will be done and air leakage will be assessed. If a specific grade-level of air leakage is present, patients will be randomized and either Hemopatch or TachoSil applied. |
| TachoSil | Active comparator | Device: TachosilPatients undergo elective pulmonary resection. Following resection, primary stapling and suturing will be done and air leakage will be assessed. If a specific grade-level of air leakage is present, patients will be randomized and either Hemopatch or TachoSil applied. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Preoperative-
- Patients, 18 years or older at the time of signing the informed consent form (ICF), undergoing elective pulmonary resections (lobectomy, segmentectomy, or wedge resection), either through open thoracotomy or through Visually Assisted Thoracotomy surgery (VATS)
- Patients or legally authorized representatives, who are able to give IC after an explanation of the proposed study, and who are willing to comply with the study requirements for therapy during the entire study treatment period
- If female of child-bearing potential, patient will present with a negative blood/urine pregnancy test, and will agree to employ adequate birth control measures for the duration of the study
- Intraoperative-
Key exclusion criteria (17 listed)
- Preoperative-
- Patients who had previous lung surgery (on the same side)
- Patients with an active, florid infection
- Patients who have received chemotherapy within the previous 3 weeks.
- Patients who have received radiation therapy within the previous 4 weeks.
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 |
|---|---|---|
| HemopatchApplied according to the current instruction for use (IFU). According to the IFU, a maximum of 7 Hemopatch 45 x 90 mm patches can be used in adults. | Device | Hemopatch |
| TachosilApplied according to the current instruction for use (IFU). | Device | TachoSil |
Primary outcome
Duration of postoperative air leakage
Time frame: Day 1 to Day 30
9 secondary outcomes
Incidence of intraoperative treatment failure
Time frame: Day 1
Incidence of patients with prolonged air leakage defined as air leakage > 5 Days
Time frame: Day 5 to Day 30
Number of additional procedures needed
Time frame: Day 1 to Day 30
Time to chest tube removal
Time frame: Day 1 to Day 30
Time in surgery (minutes) from incision to closure
Time frame: Day 1
Length of stay in hospital (days)
Time frame: Day 1 to Day 30
Number of unplanned interventions
Time frame: Day 1 to Day 30
Incidence of pre-defined postoperative Adverse Events of Special Interest (AESIs)
Time frame: Day 1 to Day 30
Number of patches used intra-operatively
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemopatch and Tachosil in people with Air Leak From Lung, run by Baxter Healthcare Corporation at 14 sites in 2 countries.
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 17 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 6 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Italy, 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Duration of postoperative air leakage (time frame: Day 1 to Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Apr 2020.