We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00665912
Recruitment Status : Completed
First Posted : April 24, 2008
Last Update Posted : March 13, 2017
Sponsor:
Collaborator:
University of Western Ontario, Canada
Information provided by (Responsible Party):
Zimmer Biomet

Brief 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.

Condition or disease Intervention/treatment
Lung Cancer Procedure: Standard post-lobectomy wound care plus use of PRP and PPPc prepared by GPS and Plasmax respectively Procedure: Standard post-lobectomy wound care

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Platelet-Rich and Concentrated Platelet Poor Plasma to Reduce Air Leak Post Lobectomy: A Randomized Controlled Trial
Study Start Date : January 2008
Primary Completion Date : May 2010
Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
1
Standard post-lobectomy wound care plus use of PRP and PPPc in the thoracic cavity.
Procedure: 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.
Active Comparator: 2
Standard post-lobectomy wound care in the thoracic cavity
Procedure: Standard post-lobectomy wound care
Standard post-lobectomy wound care



Primary Outcome Measures :
  1. Duration of postoperative air leak [ Time Frame: Every 4 hours of postop hospital stay, between 4-6 weeks postop ]

Secondary Outcome Measures :
  1. Incidence of air leak, Prolonged air leak (> days), Complications [ Time Frame: Every 4 hours of postop hospital stay, between 4-6 weeks postop ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients requiring a lobectomy

Exclusion Criteria:

  • Pneumonectomy
  • Sleeve lobectomy
  • Determination of unresectability (prior to the initiation of lobectomy)
  • Wedge resection alone

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00665912


Locations
Canada, Ontario
University of Western Ontario: Division of Thoracic Surgery
London, Ontario, Canada, N6A 5W9
Sponsors and Collaborators
Zimmer Biomet
University of Western Ontario, Canada
Investigators
Principal Investigator: Richard Inculet, MD, FRCSC, FACS University of Western Ontario, Canada
Study Chair: Darrin Payne, MD University of Western Ontario, Canada
Study Chair: Dalilah Fortin, MD University of Western Ontario, Canada
Study Chair: Richard Malthaner, MD University of Western Ontario, Canada
Study Chair: Robert Humphrey, MD University of Western Ontario, Canada

Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT00665912     History of Changes
Other Study ID Numbers: BBI-004
First Posted: April 24, 2008    Key Record Dates
Last Update Posted: March 13, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No