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

NCT00665912 | Completed

• 1 other identifier: BBI-004
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Duration of postoperative air leak

  Every 4 hours of postop hospital stay, between 4-6 weeks postop

Secondary Outcomes (1)

• Incidence of air leak, Prolonged air leak (> days), Complications

  Every 4 hours of postop hospital stay, between 4-6 weeks postop

Study Arms (2)

1

OTHER

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

2

ACTIVE COMPARATOR

Standard post-lobectomy wound care in the thoracic cavity

Procedure: Standard post-lobectomy wound care

Interventions

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

1

Standard post-lobectomy wound care PROCEDURE

Standard post-lobectomy wound care

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients requiring a lobectomy

You may not qualify if:

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

Sponsors & Collaborators

• Zimmer Biomet: lead
• University of Western Ontario, Canada: collaborator

Study Sites (1)

University of Western Ontario: Division of Thoracic Surgery

London, Ontario, N6A 5W9, Canada

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Richard Inculet, MD, FRCSC, FACS

  Western University, Canada

  PRINCIPAL INVESTIGATOR

• 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 CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2008
• First Posted: April 24, 2008
• Study Start: January 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: November 1, 2010
• Last Updated: March 13, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)