UMIN-CTR Clinical Trial

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
Email	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
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040314