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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000028228
Receipt No. R000032309
Scientific Title Low hematocrit a long-term outcome risk factor in patients needing prolonged mechanical ventilation post cardiovascular surgery: A retrospective study
Date of disclosure of the study information 2017/10/30
Last modified on 2017/07/13

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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
Middle name
Last name shunsuke takaki
Organization Yokohama City University
Division name Intensive Care Unit
Zip code
Address 3-9 Fukuura Kanazawaku Yokohama
TEL 045-787-2918
Email shunty5323@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name shunsuke takaki
Organization Yokohama City University
Division name Intensive Care Unit
Zip code
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
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 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 No longer recruiting
Date of protocol fixation
2016 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 02 Day
Last follow-up date
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
2017 Year 07 Month 13 Day


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

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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