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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035378
Receipt No. R000040314
Official scientific title of the study 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 2018/12/27

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Basic information
Official scientific title of the study Coagulopathy-related retroperitoneal, thoracoepigastric and intramuscular hematomas: A comparison between morphological CT features and clinical findings
Title of the study (Brief title) 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 Kenichi Kato
Organization Iwate Medical University
Division name Department of Radiology
Address 19-1 Uchimaru, Morioka, Japan
TEL 0196515111
Email kkato@iwate-med.ac.jp

Public contact
Name of contact person Manabu Nakayama
Organization Iwate Medical University
Division name Department of Radiology
Address 19-1 Uchimaru, Morioka, Japan
TEL 0196515111
Homepage URL
Email gakuymgt@yahoo.co.jp

Sponsor
Institute Iwate Medical University
Institute
Department

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)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 12 Month 01 Day
Anticipated trial start date
2019 Year 01 Month 04 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 N/A.

Management information
Registered date
2018 Year 12 Month 27 Day
Last modified on
2018 Year 12 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040314

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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