UMIN-CTR Clinical Trial

Basic information
Public title	Hemothorax due to spinal fractures: a systematic review
Acronym	Hemothorax due to spinal fractures: a systematic review
Scientific Title	Hemothorax due to spinal fractures: a systematic review
Scientific Title:Acronym	Hemothorax due to spinal fractures: a systematic review
Region	Japan

Condition
Condition	Hemothorax associated with traumatic spinal fractures
Classification by specialty	Emergency medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To review the characteristics, treatment, and prognosis of patients who suffered from hemothorax associated with traumatic spinal fractures.
Basic objectives2	Others
Basic objectives -Others	To review previous case reports/series on patients who suffered from hemothorax associated with traumatic spinal fractures, and descrive the characteristics, treatment, and prognosis of this entity.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. Prognosis 2. Complications
Key secondary outcomes	1. Injury severity index 2. Mechanism of injury 3. Sites of injury 4. Information regarding hemothorax 5. Timing and modalities of treatment

Base
Study type	Others,meta-analysis etc

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	Case reports or series that reported on patients who developed hemothorax due to traumatic spinal fractures.
Key exclusion criteria	Case reports or series that were published in non-peer-reviewed articles.
Target sample size	0

Research contact person
Name of lead principal investigator	1st name Kohei Middle name Last name Ninomiya
Organization	Kurashiki Central Hospital
Division name	Emergency and Critical Care Center
Zip code	710-8602
Address	1-1-1 Miwa Kurahsiki Okayama 710-8602 JAPAN
TEL	086-422-0210
Email	kn12691@kchnet.or.jp

Public contact
Name of contact person	1st name Kohei Middle name Last name Ninomiya
Organization	Kurashiki Central Hospital
Division name	Emergency and Critical Care Center
Zip code	710-8602
Address	1-1-1 Miwa Kurahsiki Okayama 710-8602 JAPAN
TEL	086-422-0210
Homepage URL
Email	kn12691@kchnet.or.jp

Sponsor
Institute	Kurashiki Central Hospital
Institute
Department

Funding Source
Organization	No funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kurashiki Central Hospital
Address	1-1-1 Miwa Kurashiki Okayama 710-8602 Japan
Tel	086-422-0210
Email	kn12691@kchnet.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	2019 Year 10 Month 10 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	2019 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date	2019 Year 10 Month 10 Day
Last follow-up date	2020 Year 04 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This is a systematic review of case reports and series on hemothorax due to traumatic spinal fractures. The current registry is intended for observational or interventional studies, and thus our current protocol may not be adequately described.

Management information
Registered date	2019 Year 10 Month 09 Day
Last modified on	2019 Year 10 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043609