UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Platelet-rich plasma to reduce air leak after pulmonary resection
Title of the study (Brief title)	PRP to reduce pulmonary air leak
Region	Japan

Condition
Condition	Air leak after pulmonary resection
Classification by specialty	Chest surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Platelet-rich plasma to reduce air leak after pulmonary resection
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Safety and efficacy for pulmonary air leak
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Platelet-rich plasma for pulmonary air leak
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with pulmonary resection
Key exclusion criteria	None
Target sample size	10

Research contact person
Name of lead principal investigator	Yukihito Saito
Organization	Kansai Medical University
Division name	Thoracic Cardiovascular Surgery
Address	Shinmachi 2-3-1, Hirakatashi, Osaka
TEL	072-804-0101
Email	saitoy@hirakata.kmu.ac.jp

Public contact
Name of contact person	Hiroyuki Kaneda
Organization	Kansai Medical University
Division name	Thoracic Cardiovascular Surgery
Address	Shinmachi 2-3-1, Hirakatashi, Osaka
TEL	072-804-0101
Homepage URL
Email	kanedah@hirakata.kmu.ac.jp

Sponsor
Institute	Kansai Medical University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2012 Year 11 Month 19 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 11 Month 01 Day
Anticipated trial start date	2012 Year 11 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 11 Month 17 Day
Last modified on	2016 Year 11 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010984