UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037832 |
|---|---|
| Receipt number | R000043135 |
| Scientific Title | Severity classification in acute limb ischemia patients |
| Date of disclosure of the study information | 2019/08/28 |
| Last modified on | 2021/08/29 09:23:26 |
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Basic information
Public title
Severity classification in acute limb ischemia patients
Acronym
ALI-classification Study
Scientific Title
Severity classification in acute limb ischemia patients
Scientific Title:Acronym
ALI-classification Study
Region
| Japan |
Condition
Condition
acute limb ischemia
Classification by specialty
| Cardiology | Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to create a new more objective severity classification for acute limb ischemia patients.
Basic objectives2
Others
Basic objectives -Others
outcome of acute limb ischemia patients
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Occurrence of ischemic reperfusion injury, difference between absolute values of potassium, CPK, LD values in femoral venous blood on affected side and blood potassium, CPK, LD values normally collected from upper limbs, femoral vein on affected side immediately after operation Association of blood potassium, CPK, and LD levels
Key secondary outcomes
1Relationship between occurrence of ischemic reperfusion injury and physical findings
2Relationship between time from onset to revascularization and cause (embolism / thrombosis)
3Final imaging findings (including the situation of 3 branches below the knee) and major amputation of the lower extremity
Avoid large limb gangrene (not amputated, but cuspid or black gangrene proximal to the ankle)Association with rate
4Death in hospital, myocardial infarction, stroke, bleeding event, unplanned revascularization additional treatment, unplanned large amputation of the lower limbs.
5Differences between physical findings of patients who have selected lower limb amputation as the primary rather than revascularization and absolute values of K, LD, CPK values of femoral venous blood before surgery and serum K, LD, CPK values of upper limbs
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Target patient
In patients with acute lower limb blood flow failure within 2 weeks of onset, perform revascularization or lower limb amputation in lower limb arteries (abdominal aorta, iliac artery, femur popliteal artery, inferior knee artery) Patient.
Selection criteria
Patients who have received sufficient explanation for participation in this study, and who have given their consent (including a surrogate) with their own will after obtaining sufficient understanding
Key exclusion criteria
1Under 20 years or over 100 years
2Patients judged to be inappropriate as subjects by the principal investigator
3Maintenance dialysis patients
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Higashitani |
| Middle name | |
| Last name | Michiaki |
Organization
Tokyo Medical University Ibaraki Center
Division name
Cardiology
Zip code
300-0395
Address
3-20-1 Amicho-Chuo, Inashiki, Ibaraki Prefecture, Japan
TEL
0298871161
mhigashi@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Higashitani |
| Middle name | |
| Last name | Michiaki |
Organization
Tokyo Medical University Ibaraki Center
Division name
Cardiology
Zip code
300-0395
Address
3-20-1 Amicho-Chuo, Inashiki, Ibaraki Prefecture, Japan
TEL
0298871161
Homepage URL
mhigashi@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University Ibaraki Center
Institute
Department
Personal name
Funding Source
Organization
others
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
Tokyo Medical University Ibaraki
Address
3-20-1 Amicho-Chuo, Inashiki, Ibaraki Prefecture, Japan
Tel
0298871161
mhigashi@tokyo-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
| 2019 | Year | 08 | Month | 28 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 25 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
Management information
Registered date
| 2019 | Year | 08 | Month | 28 | Day |
Last modified on
| 2021 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043135
| Research Plan | |
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| 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 |
