Platelet-Rich and Concentrated Platelet-Poor Plasma to Reduce Air Leak Post-Lobectomy: A Randomized Controlled Trial

NCT ID: NCT00665912

Last Updated: 2017-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

204 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lung Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Standard post-lobectomy wound care plus use of PRP and PPPc in the thoracic cavity.

Group Type OTHER

Standard post-lobectomy wound care plus use of PRP and PPPc prepared by GPS and Plasmax respectively

Intervention Type PROCEDURE

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.

2

Standard post-lobectomy wound care in the thoracic cavity

Group Type ACTIVE_COMPARATOR

Standard post-lobectomy wound care

Intervention Type PROCEDURE

Standard post-lobectomy wound care

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Standard post-lobectomy wound care plus use of PRP and PPPc prepared by GPS and Plasmax respectively

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.

Intervention Type PROCEDURE

Standard post-lobectomy wound care

Standard post-lobectomy wound care

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients requiring a lobectomy

Exclusion Criteria

* Pneumonectomy
* Sleeve lobectomy
* Determination of unresectability (prior to the initiation of lobectomy)
* Wedge resection alone
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Western Ontario, Canada

OTHER

Sponsor Role collaborator

Zimmer Biomet

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Richard Inculet, MD, FRCSC, FACS

Role: PRINCIPAL_INVESTIGATOR

Western University, Canada

Darrin Payne, MD

Role: STUDY_CHAIR

Western University, Canada

Dalilah Fortin, MD

Role: STUDY_CHAIR

Western University, Canada

Richard Malthaner, MD

Role: STUDY_CHAIR

Western University, Canada

Robert Humphrey, MD

Role: STUDY_CHAIR

Western University, Canada

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Western Ontario: Division of Thoracic Surgery

London, Ontario, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BBI-004

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

PleuraSeal Pivotal Study (US)
NCT00748124 TERMINATED PHASE3
PRP in 2ry Spontaneous Pneumothorax
NCT03830645 UNKNOWN PHASE1
PleuraSeal Post Market Study (Europe)
NCT00704171 COMPLETED PHASE4