UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031102 |
|---|---|
| Receipt number | R000035520 |
| Scientific Title | Intrapleural fibrinolytic therapy with urokinase. |
| Date of disclosure of the study information | 2018/02/01 |
| Last modified on | 2018/08/17 16:10:30 |
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Basic information
Public title
Intrapleural fibrinolytic therapy with urokinase.
Acronym
Fibrinolytic therapy with urokinase.
Scientific Title
Intrapleural fibrinolytic therapy with urokinase.
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Takashi Ibe |
Organization
Gunma University Hospital
Division name
Division of General Thoracic Surgery
Zip code
Address
3-39-15 Showa-machi, Maebashi-shi, Gunma-ken
TEL
027-220-8224
t-ibe@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Ibe |
Organization
Gunma University Hospital
Division name
Division of General Thoracic Surgery
Zip code
Address
3-39-15 Showa-machi, Maebashi-shi, Gunma-ken
TEL
027-220-8224
Homepage URL
t-ibe@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2018 | Year | 02 | Month | 01 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035520
