UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028228 |
|---|---|
| Receipt number | 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 | 2020/01/14 11:55:27 |
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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 | 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
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
shunty5323@gmail.com
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032309
