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

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: 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
• Enrollment (Actual): 204
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5W9
      • University of Western Ontario: Division of Thoracic Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients requiring a lobectomy

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Duration of postoperative air leak	Every 4 hours of postop hospital stay, between 4-6 weeks postop

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of air leak, Prolonged air leak (> days), Complications	Every 4 hours of postop hospital stay, between 4-6 weeks postop

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Collaborators: University of Western Ontario, Canada
• Investigators: Principal Investigator: Richard Inculet, MD, FRCSC, FACS, Western University, Canada; Study Chair: Darrin Payne, MD, Western University, Canada; Study Chair: Dalilah Fortin, MD, Western University, Canada; Study Chair: Richard Malthaner, MD, Western University, Canada; Study Chair: Robert Humphrey, MD, Western University, Canada

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: April 21, 2008
• First Submitted That Met QC Criteria: April 22, 2008
• First Posted (Estimate): April 24, 2008

Study Record Updates

• Last Update Posted (Actual): March 13, 2017
• Last Update Submitted That Met QC Criteria: March 10, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: BBI-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO