UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055429 |
|---|---|
| Receipt number | R000063337 |
| Scientific Title | A retrospective cohort study of the Impact of Urokinase supply deficiency on acute Empyema practice Outcome(AIUEO study) |
| Date of disclosure of the study information | 2024/09/29 |
| Last modified on | 2025/03/17 15:18:48 |
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Basic information
Public title
A retrospective cohort study of the Impact of Urokinase supply deficiency on acute Empyema practice Outcome(AIUEO study)
Acronym
The impact of urokinase supply deficiency on empyema practice outcome(AIUEO study)
Scientific Title
A retrospective cohort study of the Impact of Urokinase supply deficiency on acute Empyema practice Outcome(AIUEO study)
Scientific Title:Acronym
The impact of urokinase supply deficiency on empyema practice outcome(AIUEO study)
Region
| Japan |
Condition
Condition
empyema
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the impact of urokinase supply deficiency on conservative treatment for empyema.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Transfer to sugery
Key secondary outcomes
In-hospital mortality rate
Days from start of thoracic drainage to referral for respiratorysurgery
Duration of hospital stay
Duration of antimicrobial therapy
Duration of chest drain placement
Home discharge rate
Treatment-related adverseevents
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients 18 years of age or older who were diagnosed with acute empyema and started treatment including thoracic drainage at our department during the eligible period.
Key exclusion criteria
1) Patients who did not undergo thoracic drainage
2) Patients with chronic empyema
3) Patients with tuberculous pleurisy
4) Patients who have indicated their refusal to participate in this study either by themselves or by their family members.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Ryunosuke |
| Middle name | |
| Last name | Inaba |
Organization
Seirei Mikatahara General Hospital
Division name
Department of respiratory medicine, Respiratory disease center
Zip code
433-8558
Address
3453 Mikatahara-cho, Chuo-ku, Hamamatsu, Shizuoka, Japan
TEL
053-436-1251
i78rrr@gmail.com
Public contact
Name of contact person
| 1st name | Ryunosuke |
| Middle name | |
| Last name | Inaba |
Organization
Seirei Mikatahara General Hospital
Division name
Department of respiratory medicine, Respiratory disease center
Zip code
433-8558
Address
3453 Mikatahara-cho, Chuo-ku, Hamamatsu, Shizuoka, Japan
TEL
053-436-1251
Homepage URL
i78rrr@gmail.com
Sponsor or person
Institute
Department of respiratory medicine, Respiratory disease center, Seirei Mikatahara General Hospital
Institute
Department
Personal name
Ryunosuke Inaba
Funding Source
Organization
None
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
Institutional Review Board of Seirei Mikatahara General Hospital
Address
3453 Mikatahara-cho, Chuo-ku, Hamamatsu, Shizuoka, Japan
Tel
0534361251
mkwebmaster@sis.seirei.or.jp
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
| 2024 | Year | 09 | Month | 29 | 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
87
Results
Compared to the conventional treatment group, the group in which urokinase supply was discontinued showed a significantly higher rate of transition to surgical intervention and a shorter duration from the initiation of thoracic drainage to consultation with thoracic surgery.
Results date posted
| 2025 | Year | 03 | Month | 17 | Day |
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
Completed
Date of protocol fixation
| 2024 | Year | 09 | Month | 29 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Collect various data for the period under study in a retrospective manner using medical records.
Management information
Registered date
| 2024 | Year | 09 | Month | 05 | Day |
Last modified on
| 2025 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063337
