UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Intrapleural fibrinolytic therapy with urokinase.
Title of the study (Brief title)	Fibrinolytic therapy with urokinase.
Region	Japan

Condition
Condition	Refractory intrathoracic infection
Classification by specialty	Pneumology Chest surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the efficacy and safety of intrapleural fibrinolytic therapy with urokinase in patients with intrathoracic infections that are refractory to drainage therapy alone. Assessment of volume and aspect of drainage fluid.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Ratio of patients that were cured without surgical intervention during hospitalization.
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	Medicine
Interventions/Control_1	Intrapleural injection of 60,000 to 120,000 units of urokinase per day. Injection for 1 to 3 days.
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	1) patient with refractory intrathoracic infection 2) patient with intrathoracic drain 3) hospitalized patient 4) patient with written consent
Key exclusion criteria	1) patient with active intrathoracic bleeding 2) patient that were judged unsuitable by the treating doctor
Target sample size	30

Research contact person
Name of lead principal investigator	Takashi Ibe
Organization	Gunma University Hospital
Division name	Division of General Thoracic Surgery
Address	3-39-15 Showa-machi, Maebashi-shi, Gunma-ken
TEL	027-220-8224
Email	t-ibe@gunma-u.ac.jp

Public contact
Name of contact person	Takashi Ibe
Organization	Gunma University Hospital
Division name	Division of General Thoracic Surgery
Address	3-39-15 Showa-machi, Maebashi-shi, Gunma-ken
TEL	027-220-8224
Homepage URL
Email	t-ibe@gunma-u.ac.jp

Sponsor
Institute	Gunma University
Institute
Department

Funding Source
Organization	Gunma University
Organization
Division
Category of Funding Organization	Other
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	2018 Year 02 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 02 Month 01 Day
Anticipated trial start date	2018 Year 02 Month 01 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	2018 Year 02 Month 01 Day
Last modified on	2018 Year 08 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035520