UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049992 |
|---|---|
| Receipt number | R000056938 |
| Scientific Title | Single-center cross-sectional study on the frequency of APTT prolongation |
| Date of disclosure of the study information | 2023/01/10 |
| Last modified on | 2023/01/08 22:09:48 |
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Basic information
Public title
Frequency of preoperative APTT prolongation cases and its consideration
Acronym
Consideration of APTT prolongation
Scientific Title
Single-center cross-sectional study on the frequency of APTT prolongation
Scientific Title:Acronym
APTT cross-sectional study
Region
| Japan |
Condition
Condition
Patients with preoperative APTT prolongation
Classification by specialty
| Hematology and clinical oncology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Preoperative APTT prolongation tends to be unimportant. We will examine its frequency and actual clinical status
Basic objectives2
Others
Basic objectives -Others
Explore the frequency of preoperative APTT prolongation and its causes by dividing the APTT prolonged patients into two groups: mild and severe
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Frequency of preoperative APTT prolongation
Key secondary outcomes
Are there significant differences in patient background (age, gender, ASA classification), PT-INR, and intraoperative blood loss? Perioperative thrombotic events and factors contributing to APTT prolongation in the advanced APTT prolongation group.
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
Cases managed by anesthesiologist who underwent surgery at our hospital from April 2021 to September 2022
Key exclusion criteria
ECT cases, or cases with deficiencies in patient background and test results
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | SMichiyoshi |
| Middle name | |
| Last name | Sanuki |
Organization
National Hospital Organization Kure Medical Center and Chugoku Cancer Center
Division name
Department of Anesthesiology, Critical Care and Pain Medicine
Zip code
737-0023
Address
3-1 Aoyamacho, Kure-shi, Hiroshima
TEL
+81-823-22-3111
Sanuki.michiyoshi.hb@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Yuhei |
| Middle name | |
| Last name | Mae |
Organization
National Hospital Organization Kure Medical Center and Chugoku Cancer Center
Division name
Department of Anesthesiology, Critical Care and Pain Medicine
Zip code
737-0023
Address
3-1 Aoyamacho, Kure-shi, Hiroshima
TEL
+81-823-22-3111
Homepage URL
doct0127mae@gmail.com
Sponsor or person
Institute
National Hospital Organization Kure Medical Center and Chugoku Cancer Center
Institute
Department
Personal name
Funding Source
Organization
None
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
National Hospital Organization Kure Medical Center and Chugoku Cancer Center ethics review committee
Address
3-1 Aoyamacho, Kure-shi, Hiroshima
Tel
+81-823-22-3111
mae.yuhei.eh@mail.hosp.go.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
| 2023 | Year | 01 | 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
| 2022 | Year | 01 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 01 | Month | 02 | Day |
Last follow-up date
| 2023 | Year | 01 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The frequency of preoperative APTT prolongation will be examined in cases managed by anesthesiologist who underwent surgery at our hospital from April 2021 to September 2022, excluding ECT cases and those with deficiencies in patient background and laboratory results. We will also divide the APTT prolonged patients into two groups, mild and severe, and determine whether there are significant differences in patient background (age, gender, ASA classification), PT-INR, and intraoperative blood loss. In the severe APTT prolongation group, we will examine the presence or absence of perioperative thrombotic events and factors contributing to APTT prolongation in the severe APTT prolongation group.
Management information
Registered date
| 2023 | Year | 01 | Month | 08 | Day |
Last modified on
| 2023 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056938
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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