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Severity classification in acute limb ischemia patients

Severity classification in acute limb ischemia patients - ALI-classification Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000037832
Enrollment
200
Registered
2019-08-28
Start date
2018-09-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute limb ischemia

Interventions

None listed

Sponsors

Tokyo Medical University Ibaraki Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1Under 20 years or over 100 years 2Patients judged to be inappropriate as subjects by the principal investigator 3Maintenance dialysis patients

Design outcomes

Primary

MeasureTime frame
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

Secondary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactHigashitani Michiaki

Tokyo Medical University Ibaraki Center Cardiology

mhigashi@tokyo-med.ac.jp0298871161

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026