UMIN-CTR Clinical Trial

Basic information
Public title	Low hematocrit a long-term outcome risk factor in patients needing prolonged mechanical ventilation post cardiovascular surgery: A retrospective study
Acronym	Low hematocrit in cardiac surgery is the risk factor.
Scientific Title	Low hematocrit a long-term outcome risk factor in patients needing prolonged mechanical ventilation post cardiovascular surgery: A retrospective study
Scientific Title:Acronym	Low hematocrit in cardiac surgery is the risk factor.
Region	Japan

Condition
Condition	Cardiac surgical patients
Classification by specialty	Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We investigate whether low hematocrit in cardiac surgical patients affect long term outcome
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Long term mortality.
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	cardiovascular surgery with cardiopulmonary bypass or with off-pump coronary artery bypass grafting who required PMV more than 72 hours in the postoperative ICU between 2008 and 2012 were included.
Key exclusion criteria	Patients undergoing abdominal aortic aneurysm surgery or endovascular stent grafting, those aged 18 years or younger, and those with insufficient data in their medical record were excluded from the final analysis.
Target sample size	180

Research contact person
Name of lead principal investigator	1st name shunsuke Middle name Last name takaki
Organization	Yokohama City University
Division name	Intensive Care Unit
Zip code	236-0004
Address	3-9 Fukuura Kanazawaku Yokohama
TEL	045-787-2918
Email	shunty5323@gmail.com

Public contact
Name of contact person	1st name shunsuke Middle name Last name takaki
Organization	Yokohama City University
Division name	Intensive Care Unit
Zip code	236-0004
Address	3-9 Fukuura Kanazawaku Yokohama
TEL	045-787-2918
Homepage URL
Email	shunty5323@gmail.com

Sponsor
Institute	Yokohama City University
Institute
Department

Funding Source
Organization	Yokohama City University Department of Anesthesiology
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	Yokohama City University Hospital
Address	3-9Fukuura Kanazawa Yokohama
Tel	045-787-2918
Email	rinri@yokohama-cu.ac.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	横浜市立大学附属市民総合医療センター

Other administrative information
Date of disclosure of the study information	2017 Year 10 Month 30 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	Completed
Date of protocol fixation	2016 Year 04 Month 01 Day
Date of IRB	2014 Year 12 Month 11 Day
Anticipated trial start date	2016 Year 04 Month 02 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	We are writing manuscript of present study

Management information
Registered date	2017 Year 07 Month 13 Day
Last modified on	2020 Year 01 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032309