UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035378 |
|---|---|
| Receipt number | R000040314 |
| Scientific Title | Coagulopathy-related retroperitoneal, thoracoepigastric and intramuscular hematomas: A comparison between morphological CT features and clinical findings |
| Date of disclosure of the study information | 2019/01/04 |
| Last modified on | 2020/06/28 21:44:04 |
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Basic information
Public title
Coagulopathy-related retroperitoneal, thoracoepigastric and intramuscular hematomas: A comparison between morphological CT features and clinical findings
Acronym
Coagulopathy-related retroperitoneal, thoracoepigastric and intramuscular hematomas: A comparison between morphological CT features and clinical findings
Scientific Title
Coagulopathy-related retroperitoneal, thoracoepigastric and intramuscular hematomas: A comparison between morphological CT features and clinical findings
Scientific Title:Acronym
Coagulopathy-related retroperitoneal, thoracoepigastric and intramuscular hematomas: A comparison between morphological CT features and clinical findings
Region
| Japan |
Condition
Condition
coagulopathy-related spontaneous hematoma
Classification by specialty
| Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To characterize patients with coagulopathy-related retroperitoneal, thoracoepigastric and intramuscular hematomas by comparison between CT morphological features and clinicolaboratory findings to aid physicians in the therapeutic decision.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The relationship between CT morphological features of hematoma related to coagulopathy and clinicolaboratory findings
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients with spontaneous hematoma in either their retroperitoneum or thoracoabdominal wall or muscles
2. hematoma related to coagulopathy
Key exclusion criteria
1.hematoma related to a trauma
2.hematoma related to neoplasms (e.g., renal angiomyolipoma and renal cell carcinoma)
3.hematoma related to vascular causes (e.g., renal and abdominal aortic aneurysms)
4.iatrogenic hematoma
Target sample size
47
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenichi Kato |
Organization
Iwate Medical University
Division name
Department of Radiology
Zip code
Address
19-1 Uchimaru, Morioka, Japan
TEL
0196515111
kkato@iwate-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Manabu Nakayama |
Organization
Iwate Medical University
Division name
Department of Radiology
Zip code
Address
19-1 Uchimaru, Morioka, Japan
TEL
0196515111
Homepage URL
gakuymgt@yahoo.co.jp
Sponsor or person
Institute
Iwate Medical University
Institute
Department
Personal name
Funding Source
Organization
Iwate Medical 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
| 2019 | Year | 01 | Month | 04 | 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
47
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
Completed
Date of protocol fixation
| 2018 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A.
Management information
Registered date
| 2018 | Year | 12 | Month | 27 | Day |
Last modified on
| 2020 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040314
