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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00665912
• Other study ID #: BBI-004
• Status: Completed
• Phase: N/A
• First received: April 21, 2008
• Last updated: March 10, 2017
• Start date: January 2008
• Est. completion date: November 2010

Study information

• Verified date: March 2017
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: November 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients requiring a lobectomy

Exclusion Criteria:

• Pneumonectomy

• Sleeve lobectomy

• Determination of unresectability (prior to the initiation of lobectomy)

• Wedge resection alone

Related Conditions & MeSH terms

• Lung Cancer

Intervention

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.
• Standard post-lobectomy wound care
Standard post-lobectomy wound care

Locations

Country	Name	City	State
Canada	University of Western Ontario: Division of Thoracic Surgery	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Zimmer Biomet	University of Western Ontario, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of postoperative air leak		Every 4 hours of postop hospital stay, between 4-6 weeks postop
Secondary	Incidence of air leak, Prolonged air leak (> days), Complications		Every 4 hours of postop hospital stay, between 4-6 weeks postop