UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043243 |
|---|---|
| Receipt number | R000049352 |
| Scientific Title | Prevalence of preoperative anemia in our surgical patients |
| Date of disclosure of the study information | 2021/02/04 |
| Last modified on | 2024/02/24 19:07:01 |
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Basic information
Public title
Prevalence of preoperative anemia in our surgical patients
Acronym
Prevalence of preoperative anemia in our surgical patients
Scientific Title
Prevalence of preoperative anemia in our surgical patients
Scientific Title:Acronym
Prevalence of preoperative anemia in our surgical patients
Region
| Japan |
Condition
Condition
patients undergoing surgery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
There are increasing reports from around the world that proactive interventions for anemia, starting before surgery and continuing throughout the perioperative period, have improved the outcomes of surgical patients. Currently, there are only a few reports on preoperative anemia treatment in Japan, and not enough efforts have been made yet. Therefore, to effectively intervene in preoperative anemia in the future, it is necessary to understand the status of preoperative anemia in our hospital.
Basic objectives2
Others
Basic objectives -Others
Identify the current situation.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Hemoglobin level just before surgery
Key secondary outcomes
Ht,MCV(Mean Corpuscular Volume),ALB,CRP
BUN,Cre,eGFR,PT-INR,APTT,30-day mortality
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
| 1 | days-old | <= |
Age-upper limit
| 120 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who underwent surgery at our hospital
Key exclusion criteria
None
Target sample size
7817
Research contact person
Name of lead principal investigator
| 1st name | Yoshiko |
| Middle name | |
| Last name | Onodera |
Organization
Asahikawa Medical University Hospital
Division name
Surgical Operation Department
Zip code
090
Address
Midorigaoka higashi 2-1-1-1, Asahikawa, Hokkaido, Japan
TEL
0166682583
onoderayoshiko@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yoshiko |
| Middle name | |
| Last name | Onodera |
Organization
Asahikawa Medical University Hospital
Division name
Surgical Operation Department
Zip code
078-8510
Address
Midorigaoka higashi 2-1-1-1, Asahikawa, Hokkaido, Japan
TEL
0166682583
Homepage URL
onoderayoshiko@yahoo.co.jp
Sponsor or person
Institute
Asahikawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Asahikawa Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Asahikawa Medical University Research Ethics Committee
Address
Midorigaoka-higashi 2-1-1-1, Asahikawa, Hokkaido, 078-8510, Japan
Tel
0166-68-2297
sho-kenkyu@jimu.asahikawa-med.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 02 | Month | 04 | Day |
Related information
URL releasing protocol
no release
Publication of results
Unpublished
Result
URL related to results and publications
no publication
Number of participants that the trial has enrolled
7816
Results
Preoperative anemia was present in approximately 40% of patients for whom preoperative intervention was possible. Patients with preoperative anemia had a high incidence of postoperative AKI at our institution.
Results date posted
| 2023 | Year | 02 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients who underwent surgery at our hospital between January 1 and December 31, 2020
Participant flow
This is a retrospective study, so if the patient does not refuse, it will be included in the study.
Adverse events
No adverse events
Outcome measures
Anemia Prevalence
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2021 | Year | 01 | Month | 08 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 06 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Data extraction from medical information
Management information
Registered date
| 2021 | Year | 02 | Month | 04 | Day |
Last modified on
| 2024 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049352
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
