UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053878 |
|---|---|
| Receipt number | R000061389 |
| Scientific Title | Perioperative whole blood viscosity changes in non-cardiac surgery patients: an exploratory prospective study |
| Date of disclosure of the study information | 2024/03/18 |
| Last modified on | 2024/03/16 09:53:26 |
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Basic information
Public title
Perioperative whole blood viscosity changes in non-cardiac surgery patients
Acronym
blood viscosity changes in non-cardiac surgery
Scientific Title
Perioperative whole blood viscosity changes in non-cardiac surgery patients: an exploratory prospective study
Scientific Title:Acronym
Perioperative whole blood viscosity changes in non-cardiac surgery patients
Region
| Japan |
Condition
Condition
non cardiac surgery patients
Classification by specialty
| Anesthesiology | Laboratory medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
An exploratory study of perioperative changes in blood viscosity in non-cardiac surgery patients. Changes in blood viscosity and high viscosity have been reported to be associated with thrombosis. Observation of perioperative changes in blood viscosity over time, depending on the type of patient group, procedure, and duration of surgery, is essential for future research.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood viscosity change from the initiation of surgery to the end of surgery
Key secondary outcomes
Intraoperative factors associated with changes in blood viscosity
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients who are 18 years of age or older.
2) Patients who have received a thorough explanation of the study and have given written consent.
Key exclusion criteria
A participant who is one of the following
1) Patients who have expressed their refusal to participate in this study.
2) Patients with abnormal protein elevation (primary macroglobulinemia, multiple myeloma, etc.)
3) Patients who may have hyperglobulinemia (e.g., collagen disease, liver cirrhosis, chronic infectious disease, etc.)
4) Patients with diseases that cause impaired red blood cell deformability, etc.
5) Other subjects judged to be unsuitable by the principal investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kyongsuk |
| Middle name | |
| Last name | Son |
Organization
Chiba-University Hospital
Division name
Department of Anesthesiology
Zip code
2608677
Address
1-8-1 Inohana Chuuou-ku, Chiba-shi
TEL
0432227171
aday5599@chiba-u.jp
Public contact
Name of contact person
| 1st name | Kyongsuk |
| Middle name | |
| Last name | Son |
Organization
Chiba-University Hospital
Division name
Department of Anesthesiology
Zip code
2608677
Address
1-8-1 Inohana Chuuou-ku, Chiba-shi
TEL
0432227171
Homepage URL
kyong0203suk@yahoo.co.jp
Sponsor or person
Institute
ChibaUniversity
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba University Hospital Observational Research Ethics Review Committee
Address
1-8-1 Inohana Chuuou-ku, Chiba-shi
Tel
0432227171
hsp-kansaturinri@chiba-u.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
| 2024 | Year | 03 | Month | 18 | 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
| 2024 | Year | 03 | Month | 07 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 08 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 18 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Primary outcome: change in blood viscosity before and after surgery.
Secondary outcome: intra-operative factors associated with changes in blood viscosity
The following clinical information should be collected from the medical records
A) Age, gender, life history (e.g. alcohol consumption, smoking), occupational history, medical history, concomitant medications, family history
B) Clinical examination results, including biochemical and haematological tests
C) Surgical technique, duration of surgery, anaesthesia duration and information available from anaesthesia charts
D) Medical information such as post-operative transfusion volume, blood transfusion volume, vital signs, etc.
Translated with DeepL.com (free version)
Management information
Registered date
| 2024 | Year | 03 | Month | 16 | Day |
Last modified on
| 2024 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061389
| Research Plan | |
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