NCT00567801
Terminated
Phase 3
Prospektive, Randomisierte Multicenter-Studie Zur Optimierung Der Therapie Der Akuten Ischämie Der Unteren Extremitäten Durch Die Kontrollierte Extremitätenreperfusion (Prospective, Randomized Multicenter - Study for Optimization of Therapy of the Acute Ischemic Limb by Controlled Reperfusion)
University Hospital Freiburg23 sites in 2 countries250 target enrollmentSeptember 2002
ConditionsLower Extremity Ischemia
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Lower Extremity Ischemia
- Sponsor
- University Hospital Freiburg
- Enrollment
- 250
- Locations
- 23
- Primary Endpoint
- Amputation-free survival
- Status
- Terminated
- Last Updated
- 17 years ago
Overview
Brief Summary
The purpose of this study is to prove the findings of a preliminary study which strongly suggest the hypothesis that the result of conventional embolectomy for acute, severe lower-limb ischemia can be improved by controlled reperfusion.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients aged 18 years or older
- •Patients with arterial occlusion of one or both lower limbs with acute decompensated ischemia (Rutherford IIA to III)
- •Informed consent of the patient
Exclusion Criteria
- •Previous attempt of recanalisation (e.g. lysis therapy)
- •Known A. poplitea aneurysm of the affected extremity
- •Severe heart failure NYHA IV
- •Known atrial thrombus
- •Terminal renal insufficiency (creatinine \>10mg/dl or current dialysis therapy, previous transplantation of kidney)
- •Hypersensitivity to allopurinol
- •Hypersensitivity to one component part of the reperfusion solution
- •Participation in a clinical trial during the study or 30 days before
- •Pregnancy or lactation
- •Patient incapable of contracting or not able to understand the character, meaning and consequences of the clinical trial
Outcomes
Primary Outcomes
Amputation-free survival
Time Frame: 28 days
Secondary Outcomes
- Systemic complications in both therapy groups(4 weeks)
- Tolerance of reperfusion solution(4 weeks)
- Neurological status (motor function, sensor function) of ischemic limb(4 weeks)
- Lethality(12 months)
Study Sites (23)
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