Lung CancerNCT00665912
Platelet-Rich and Concentrated Platelet-Poor Plasma to Reduce Air Leak Post-Lobectomy: A Randomized Controlled Trial
A study testing Standard post-lobectomy wound care plus use of PRP and PPPc prepared by GPS and Plasmax respectively and Standard post-lobectomy wound care in people with Lung Cancer, run by Zimmer Biomet at 1 site in Canada.
Trial summary
The purpose of this study is to determine whether the use of platelet-rich plasma (PRP) and concentrated platelet-poor plasma (PPPc) can reduce the duration of post-operative air leak after lobectomy for lung tumours. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Standard post-lobectomy wound care plus use of PRP and PPPc prepared by GPS and Plasmax respectively and Standard post-lobectomy wound care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2008to Nov 2010
- 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
- Patients requiring a lobectomy
Who cannot join
- Pneumonectomy
- Sleeve lobectomy
- Determination of unresectability (prior to the initiation of lobectomy)
- Wedge resection alone
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Western Ontario: Division of Thoracic Surgery
London, Ontario, N6A 5W9
About this study
Official title: Platelet-Rich and Concentrated Platelet Poor Plasma to Reduce Air Leak Post Lobectomy: A Randomized Controlled Trial
The purpose of this study is to determine whether the use of platelet-rich plasma (PRP) and concentrated platelet-poor plasma (PPPc) can reduce the duration of post-operative air leak after lobectomy for lung tumours.
- Conditions
- Lung Cancer
- Being tested
- Standard post-lobectomy wound care plus use of PRP and PPPc prepared by GPS and Plasmax respectively, Standard post-lobectomy wound care
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard post-lobectomy wound care plus use of PRP and PPPc prepared by GPS and Plasmax respectivelyProcedure or surgery
GPS is used to create the platelet rich plasma (PRP). Plasmax is used to create the concentrated platelet-poor plasma (PPPc). Both PRP and PPPc will be used for wound care in the thoracic cavity post-lobectomy.
Standard post-lobectomy wound careProcedure or surgery
Standard post-lobectomy wound care
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Standard post-lobectomy wound care plus use of PRP and PPPc in the thoracic cavity. Receives: Procedure: Standard post-lobectomy wound care plus use of PRP and PPPc prepared by GPS and Plasmax respectively |
| 2 | Active comparator | Standard post-lobectomy wound care in the thoracic cavity Receives: Procedure: Standard post-lobectomy wound care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of postoperative air leak
Measured: Every 4 hours of postop hospital stay, between 4-6 weeks postop
Secondary outcomes (1)
Incidence of air leak, Prolonged air leak (> days), Complications
Measured: Every 4 hours of postop hospital stay, between 4-6 weeks postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2008 (estimated)
- Study startJan 2008
- Primary completionMay 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Western Ontario, Canada
- Responsible party
- Sponsor
- Investigators
- Richard Inculet, MD, FRCSC, FACS, Principal investigator, Western University, CanadaDarrin Payne, MD, Study chair, Western University, CanadaDalilah Fortin, MD, Study chair, Western University, CanadaRichard Malthaner, MD, Study chair, Western University, CanadaRobert Humphrey, MD, Study chair, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00665912
- Sponsor's protocol ID
- BBI-004
- Status last verified
- Mar 2017
- First submitted
- 21 Apr 2008
- Last updated
- 13 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet-Rich and Concentrated Platelet Poor Plasma to Reduce Air Leak Post Lobectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00665912
- Acronym / sponsor ID
- BBI-004
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Collaborators
- University of Western Ontario, Canada
- Study start
- Jan 2008
- Primary completion
- May 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 24 Apr 2008 (estimated)
- 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.
The purpose of this study is to determine whether the use of platelet-rich plasma (PRP) and concentrated platelet-poor plasma (PPPc) can reduce the duration of post-operative air leak after lobectomy for lung tumours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Procedure: Standard post-lobectomy wound care plus use of PRP and PPPc prepared by GPS and Plasmax respectivelyStandard post-lobectomy wound care plus use of PRP and PPPc in the thoracic cavity. |
| 2 | Active comparator | Procedure: Standard post-lobectomy wound careStandard post-lobectomy wound care in the thoracic cavity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients requiring a lobectomy
Key exclusion criteria (4 listed)
- Pneumonectomy
- Sleeve lobectomy
- Determination of unresectability (prior to the initiation of lobectomy)
- Wedge resection alone
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 |
|---|---|---|
| Standard post-lobectomy wound care plus use of PRP and PPPc prepared by GPS and Plasmax respectivelyGPS is used to create the platelet rich plasma (PRP). Plasmax is used to create the concentrated platelet-poor plasma (PPPc). Both PRP and PPPc will be used for wound care in the thoracic cavity post-lobectomy. | Procedure or surgery | 1 |
| Standard post-lobectomy wound careStandard post-lobectomy wound care | Procedure or surgery | 2 |
Primary outcome
Duration of postoperative air leak
Time frame: Every 4 hours of postop hospital stay, between 4-6 weeks postop
1 secondary outcome
Incidence of air leak, Prolonged air leak (> days), Complications
Time frame: Every 4 hours of postop hospital stay, between 4-6 weeks postop
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 13 Mar 2017.
- Individual participant dataSharing planned: No
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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.
Richard Inculet, MD, FRCSC, FACS principal investigator
Western University, Canada
Darrin Payne, MD study chair
Western University, Canada
Dalilah Fortin, MD study chair
Western University, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard post-lobectomy wound care plus use of PRP and PPPc prepared by GPS and Plasmax respectively and Standard post-lobectomy wound care in people with Lung Cancer, run by Zimmer Biomet at 1 site in Canada.
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 1 inclusion and 4 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 13 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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 leak (time frame: Every 4 hours of postop hospital stay, between 4-6 weeks postop). 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 13 Mar 2017.