Clinical Trial Results:
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.
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Summary
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EudraCT number |
2017-003931-12 |
Trial protocol |
CZ ES IT |
Global end of trial date |
09 Jul 2019
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Results information
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Results version number |
v1(current) |
This version publication date |
14 Oct 2020
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First version publication date |
14 Oct 2020
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
BXU513667
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT03450265 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Baxter Healthcare
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Sponsor organisation address |
1 Baxter Pkwy, Deerfield, United States, 60015
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Public contact |
Sr Clinical Project Manager, Baxter R&D Europe SPRL, 224 948-7359, Global_CORP_ClinicalTrialsDisclosure@baxter.com
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Scientific contact |
Sr Clinical Project Manager, Baxter R&D Europe SPRL, 224 948-7359, Global_CORP_ClinicalTrialsDisclosure@baxter.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
31 Jan 2020
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
09 Jul 2019
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Global end of trial reached? |
Yes
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Global end of trial date |
09 Jul 2019
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To evaluate the efficacy of Hemopatch compared to TachoSil in postoperative air leak duration after pulmonary resection.
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Protection of trial subjects |
The DSMB reviewed safety and efficacy data from the study at the following data cutoffs (1) after 50% of subjects experienced a post-operative air leak, had been completed or withdrawn and (2) study completion.
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Background therapy |
- | ||
Evidence for comparator |
In a study conducted by Filosso et al (2013)2, TachoSil sealant was found to be superior to standard stapling and suturing aerostatic techniques in reducing post-operative air leaks. | ||
Actual start date of recruitment |
25 Jun 2018
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Spain: 74
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Country: Number of subjects enrolled |
Italy: 95
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Worldwide total number of subjects |
169
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EEA total number of subjects |
169
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
63
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From 65 to 84 years |
106
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||||||||||||||
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Pre-assignment
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Screening details |
- | ||||||||||||||||||||||||
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Pre-assignment period milestones
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Number of subjects started |
279 [1] | ||||||||||||||||||||||||
Number of subjects completed |
169 | ||||||||||||||||||||||||
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Pre-assignment subject non-completion reasons
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Reason: Number of subjects |
Pre-operative Screen Failures: 19 | ||||||||||||||||||||||||
Reason: Number of subjects |
Randomized with Intra-operative Screen Failures: 91 | ||||||||||||||||||||||||
| Notes [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: Subjects captured in pre-assignment period include (1) pre-operative screen failures and (2) randomized with intra-operative screen failures. Only those that completed pre-assignment were randomized as intra-operative eligible and provided study treatment. |
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Period 1
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Period 1 title |
Randomized, Intra-Operative Eligibility (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Single blind | ||||||||||||||||||||||||
Roles blinded |
Subject | ||||||||||||||||||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Hemopatch | ||||||||||||||||||||||||
Arm description |
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 Hemopatch applied. | ||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||
Investigational medicinal product name |
Hemopatch
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Sealant matrix
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Routes of administration |
Soft tissue use
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Dosage and administration details |
The appropriate size of the pad was selected so that it overlapped the margins of the wound surface by about 1 cm. The size of the patches used for the study was 45 x 90 mm. It was permitted to cut the pad to the desired size and shape. According to the IFU, a maximum of 7 HEMOPATCH 45 x 90 mm patches can be used in adults.
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Arm title
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TachoSil | ||||||||||||||||||||||||
Arm description |
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 TachoSil applied. | ||||||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||||||
Investigational medicinal product name |
TachoSil
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Sealant matrix
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Routes of administration |
Soft tissue use
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Dosage and administration details |
TachoSil was applied according to the summary of product characteristics.
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Baseline characteristics reporting groups
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Reporting group title |
Hemopatch
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Reporting group description |
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 Hemopatch applied. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
TachoSil
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Reporting group description |
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 TachoSil applied. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Hemopatch
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Reporting group description |
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 Hemopatch applied. | ||
Reporting group title |
TachoSil
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Reporting group description |
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 TachoSil applied. | ||
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End point title |
Duration of postoperative air leakage | ||||||||||||
End point description |
Duration was calculated as date/time of end of air leak minus date/time of end of surgery. Number of subjects included only subjects with a calculable post-operative air leak duration. The predicted mean for post-operative air leak duration was produced by an ANOVA with post-operative air leak duration as the response variable and with site, final air leak grade, type of surgery performed, and treatment as fixed effects.
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End point type |
Primary
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End point timeframe |
Day 1 to Day 30
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Statistical analysis title |
Stats | ||||||||||||
Comparison groups |
Hemopatch v TachoSil
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Number of subjects included in analysis |
164
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority [1] | ||||||||||||
P-value |
= 0.4275 | ||||||||||||
Method |
ANOVA | ||||||||||||
Parameter type |
Mean difference (net) | ||||||||||||
Point estimate |
0.81
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-1.2 | ||||||||||||
upper limit |
2.82 | ||||||||||||
| Notes [1] - Based on published data a non-inferiority margin was calculated. In order to show non-inferiority, the upper limit of the 95% two-sided CI around the difference in predicted means needed to be below 1.2 days. |
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End point title |
Number of Subjects with Intra-operative Treatment Failure | |||||||||
End point description |
A subject was considered a treatment failure if rescue treatment occurred. Rescue treatment could include any surgical technique or sealant (fibrin or non-fibrin), except TachoSil in subjects randomized to TachoSil.
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End point type |
Secondary
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End point timeframe |
Day 1
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| No statistical analyses for this end point | ||||||||||
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End point title |
Number of Subjects with Prolonged Air Leaks > 5 days | |||||||||
End point description |
Prolonged air leaks prolong the need for chest tube, which is associated with pain, reduced mobility and may lead to further complications. Air leak control and reducing its occurrence can have positive outcomes for the subjects including those being mobilized from bed sooner post-surgery, achieving correct and efficient respiratory function, as well as shortening the time until chest tube removal and the overall length of hospital stay.
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End point type |
Secondary
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End point timeframe |
Day 1 to Day 30
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| No statistical analyses for this end point | ||||||||||
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End point title |
Number of Subjects achieving Hemostasis After Application of Product | |||||||||
End point description |
Hemostasis is the act of restricting or stopping blood flow from a damaged vessel or organ.
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End point type |
Secondary
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End point timeframe |
Day 1
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| No statistical analyses for this end point | ||||||||||
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End point title |
Number of Subjects having the need for additional procedures | |||||||||
End point description |
Type of procedures include chest drainage, re-operation, respiratory assistance, and blood transfusion.
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End point type |
Secondary
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End point timeframe |
Day 1 to Day 30
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| No statistical analyses for this end point | ||||||||||
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End point title |
Time to Chest Tube Removal | ||||||||||||
End point description |
Calculated as date/time of chest tube removal minus date/time of end of surgery.
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End point type |
Secondary
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End point timeframe |
Day 1 to Day 30
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Time in surgery | ||||||||||||
End point description |
Calculated as date/time of last skin suture minus date/time of first skin incision.
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End point type |
Secondary
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End point timeframe |
Day 1
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Length of Stay in Hospital | ||||||||||||
End point description |
Calculated as (date of hospital discharge minus date of hospital admission) + 1.
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End point type |
Secondary
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End point timeframe |
Day 1 to Day 30
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Number of Unplanned Interventions | ||||||||||||
End point description |
Additional procedures.
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End point type |
Secondary
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End point timeframe |
Day 1 to Day 30
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Number of Subjects with Treatment Emergent Adverse Events of Special Interest | |||||||||||||||||||||
End point description |
Pre-defined post-operative adverse events of special interest (AESIs) up to 30 ± 3 days after surgery: may include pneumothorax, bronchopleural fistula, emphysema (subcutaneous and mediastinal), pleural effusions, post-operative respiratory failure, empyema, and allergic reactions in reasonable temporal relationship with the product application.
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End point type |
Secondary
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End point timeframe |
Day 1 to Day 30
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| No statistical analyses for this end point | ||||||||||||||||||||||
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End point title |
Number of patches used | ||||||||||||
End point description |
Intra-operatively.
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End point type |
Secondary
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End point timeframe |
Day 1
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| No statistical analyses for this end point | |||||||||||||
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Adverse events information [1]
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Timeframe for reporting adverse events |
Day 1 to Day 30
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Adverse event reporting additional description |
Treatment Emergent AE/SAE's were reported.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
20
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Reporting groups
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Reporting group title |
Hemopatch
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Reporting group description |
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 Hemopatch applied. Treatment-Emergent AE's reported. Non-serious AE's reflect frequency threshold. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
TachoSil
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Reporting group description |
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 TachoSil applied. Treatment-Emergent AE's reported. Non-serious AE's reflect frequency threshold. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: There were no treatment emergent non-serious Adverse Events with 5% or more frequency. |
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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17 Aug 2017 |
• Addition of hemostasis as a secondary endpoint
• Addition of reference that for target sites that are dry, the tissue can be moistened with Sodium
Bicarbonate solution.
• Removal of HbA1c test from End of Study Visit |
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26 Oct 2017 |
• Sample size was decreased to account for correct assumptions. It was originally assumed that 35% of subjects were expected to not experience a post-operative air leak, which was corrected to 5%. Originally it was planned to screen 326 subjects to randomize and treat 240 subjects. This was updated to screen 278 subjects to randomize 166 subjects. The cap of randomized subjects following the interim analysis was originally 300 subjects, which was updated to 250 subjects. |
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02 Nov 2017 |
• Changed digital CT drainage to CT drainage system to allow for both traditional and digital drainage systems.
• Addition of stratification according to approach to surgery used (open or VATS).
• Removal of reference to X-Rays which was performed according to hospital standards at the discretion of the investigator. |
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13 Feb 2018 |
• Alignment of study scheme with updates to study procedure.
• Clarification that CT will be managed as per standard of care.
• Removal of restriction of oral measurement to take temperature
• Addition of a description of surgery and air leak monitoring
• Clarification of the exclusion criterion of florid infection as active and removing chronic steroid use as an exclusion criterion.
• Removal of capping strategy on randomization and 2:1:1 allocation of randomized subjects across surgery typed (lobectomy: segmentectomy: wedge resection).
• Addition of fibrinogen to the clinical laboratory tests
• Laboratory tests were moved from Visit 4 (Day 4) to Visit 3 (Day 3). |
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02 May 2018 |
• Clarification that Visit 4, Visit 5, and Visit 6 were only to be done if the subjects had not yet been discharged.
• A note that duration of post-operative air leak was to be monitored and recorded as well as time to CT removal. If these 2 events were at different times, this was required to be documented to ensure accuracy and efficiency. If post-operative air leak persisted, subjects may have been discharged with a Heimlich valve only after observing for at least 5 days post-operatively, indicating these subjects had PAL. |
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07 Jan 2019 |
• Update to description of the analysis sets. For all efficacy analyses, the FAS was used as the primary analysis, while the PPS was used as supportive analysis. There were 2 main reasons for this change.
Firstly, the sample size calculation did not indicate any stipulation to allow for extra recruitment of subjects to account for subjects falling out of the primary analysis set due to protocol deviations. As such, to achieve the correct sample size for the primary analysis, the FAS was used. Secondly, the nature of PPS was such that it had an inherent bias for the treatment groups as it attempted to create a ‘perfect’ subset of the population for whom the medical device was administered. To prevent such a bias from influencing the results, the FAS was preferred for the primary analysis set.
• Clarification that appropriate rules to restart the study were outlined in the Data Safety Monitoring Board charter. |
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12 Jun 2019 |
Sponsor’s Legal Representative and Medical Monitor were updated. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
