UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043754 |
|---|---|
| Receipt number | R000049949 |
| Scientific Title | Retrospective analysis of the relationship between calcium concentration and QTc interval in intraoperative massive bleeding |
| Date of disclosure of the study information | 2021/03/26 |
| Last modified on | 2021/03/26 16:33:07 |
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Basic information
Public title
Retrospective analysis of the relationship between calcium concentration and QTc interval in intraoperative massive bleeding
Acronym
Retrospective analysis of the relationship between calcium concentration and QTc interval in intraoperative massive bleeding
Scientific Title
Retrospective analysis of the relationship between calcium concentration and QTc interval in intraoperative massive bleeding
Scientific Title:Acronym
Retrospective analysis of the relationship between calcium concentration and QTc interval in intraoperative massive bleeding
Region
| Japan |
Condition
Condition
Massive bleeding
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the relationship between ionized calcium concentration and QTc interval in intraoperative massive bleeding
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between ionized calcium concentration and QTc interval
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. Massive bleeding more than 5000ml
2. RBC transfusion
3. More than 6 blood gas analyzes
Key exclusion criteria
1. Administration of the drugs affecting QTc interval
2. Remarkable irregular RR interval
3. Less than 6 blood gas analyzes with calculable QTc intervals in the same inhalational anesthetic concentration
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Sugiyama |
Organization
Shinshu University Hospital
Division name
Department of Anesthesiology and Resuscitology
Zip code
3908621
Address
3-1-1, Asahi, Matsumoto, Nagano
TEL
+81-261-37-2670
ysugiyama@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Sugiyama |
Organization
Shinshu University Hospital
Division name
Department of Anesthesiology and Resuscitology
Zip code
390-8621
Address
3-1-1, Asahi, Matsumoto, Nagano
TEL
+81-261-37-2670
Homepage URL
ysugiyama@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
Self 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
Ethical Committee of Shinshu University School of Medicine
Address
3-1-1, Asahi, Matsumoto, Nagano
Tel
0263-37-2572
mdrinri@shinshu-u.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
信州大学医学部附属病院（長野県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 03 | Month | 26 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 12 | Month | 08 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 08 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 08 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective analysis
Management information
Registered date
| 2021 | Year | 03 | Month | 26 | Day |
Last modified on
| 2021 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049949
