Condition category
Respiratory
Date applied
26/02/2009
Date assigned
24/07/2009
Last edited
12/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.heartofengland.nhs.uk/

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

Publication citations

Additional files

Editorial Notes

12/07/2016: No publications found, verifying study status with principal investigator.