Contact information
Type
Scientific
Primary contact
Mr Pala Rajesh
ORCID ID
Contact details
Consultant Thoracic Surgeon
Regional Department of Thoracic Surgery
Birmingham Heartlands Hospital
Heart of England NHS Foundation Trust
Bordesley Green East
Birmingham
B9 5SS
United Kingdom
+44 121 424 3561
pala.rajesh@heartofengland.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Version 2
Study information
Scientific title
A controlled trial comparing stapling with BioGlue® surgical adhesive versus stapling with buttressed bovine pericardium in lung volume reduction surgery (LVRS)
Acronym
Study hypothesis
BioGlue® on staple line is as effective as stapling with pericardial buttressing in reducing air leaks in lung volume reduction surgery (LVRS). Phase 1 will establish the role and efficacy of BioGlue® in LVRS and phase 2 will compare its benefits over buttressed pericardial stapling.
Ethics approval
Birmingham East North and Solihull Research Ethics Committee approved in July 2005 (ref: 05/Q2703/77). Amendment in January 2009.
Study design
Randomised self-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Surgery for emphysema
Intervention
Patients are randomised via sealed randomised envolopes opened on the day of surgery. Patients are then randomised to LVRS with two different adjuncts to staple line:
1. BioGlue®
2. Pericardial buttress
Intervention type
Other
Phase
Phase IV
Drug names
Primary outcome measures
To demonstrate an increase in the frequency of an air leak free post-operative hospital course for patients receiving BioGlue® as a pneumostatic sealant as compared to patients receiving the pericardial buttressed stapling. Post-operatively, occurrence of air leaks will be assessed on a per patient basis, twice daily.
Secondary outcome measures
1. Incidence of re-operation due to air leaks
2. Volume of fluid loss in chest tube drain
3. Time to air leak cessation
4. Incidence of complications/adverse events
5. Early (hospital discharge) mortality and late mortality (through final follow-up)
Measured twice daily.
Overall trial start date
01/09/2005
Overall trial end date
01/10/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients undergoing LVRS
2. Forced expiratory volume in one second (FEV1) less than 40%
3. FEV1/forced vital capacity (FVC) ratio less than 50% following challenges with beta 2 agonists/ipratropium bromide and a trial of oral corticosteroids
4. Residual volume of greater than 140%
5. Severe emphysema with heterogeneity ("target areas") documented on high resolution computed tomography (CT) scans
6. Less than 75 years of age, but greater than 18 years of age, either sex
7. Clinically stable for 1 month before entry to the study
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
25
Participant exclusion criteria
1. Patients who do not consent to the trial
2. Patients with known hypersensitivity to albumin, bovine products, or glutaraldehyde
3. Patients who have been treated with an investigational product and have not completed the entire follow-up period for that investigational product
4. Patients who are unwilling or unable to complete all study evaluations
Recruitment start date
01/09/2005
Recruitment end date
01/10/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Consultant Thoracic Surgeon
Birmingham
B9 5SS
United Kingdom
Sponsor information
Organisation
Heart of England NHS Foundation Trust (UK)
Sponsor details
Birmingham Heartlands Hospital
Bordesley Green East
Birmingham
B9 5SS
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Industry
Funder name
CryoLife Europa Ltd (UK) - educational grant
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary