CRAIL - Controlled Reperfusion of the Acutely Ischemic Limb
NCT ID: NCT00567801
Last Updated: 2008-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
250 participants
INTERVENTIONAL
2002-09-30
2010-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
conventional embolectomy/thrombectomy
conventional embolectomy/thrombectomy
2
embolectomy/thrombectomy with controlled reperfusion
embolectomy/thrombectomy with controlled reperfusion
Interventions
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conventional embolectomy/thrombectomy
embolectomy/thrombectomy with controlled reperfusion
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* Abuse to drugs or alcohol
18 Years
ALL
No
Sponsors
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Dr. Köhler Chemie (Alsbach-Hähnlein, Germany)
UNKNOWN
HP-Medica (Augsburg, Germany)
UNKNOWN
GEA (Frederiksberg, Denmark)
UNKNOWN
Kardialagut (München, Germany)
UNKNOWN
University Hospital Freiburg
OTHER
Principal Investigators
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Friedhelm Beyersdorf, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Department of Cardiovascular Surgery, University Medical Center Freiburg
Locations
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Universität Innsbruck
Innsbruck, , Austria
St. Johanns-Spital Salzburg
Salzburg, , Austria
University Medical Center Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Städtisches Klinikum Karlsruhe
Karlsruhe, Baden-Wurttemberg, Germany
Klinikum Lahr
Lahr, Baden-Wurttemberg, Germany
Klinikum Villingen-Schwenningen
Villingen-Schwenningen, Baden-Wurttemberg, Germany
Herzzentrum Bad Krozingen
Bad Krozingen, , Germany
Universitätsklinikum Bonn
Bonn, , Germany
Kreisklinikum Donaueschingen
Donaueschingen, , Germany
St. Johannes-Hospital Dortmund
Dortmund, , Germany
Marienhospital Altenessen
Essen, , Germany
Universitätsklinikum Frankfurt
Frankfurt, , Germany
St. Marien-Hospital Buer, Gelsenkirchen
Gelsenkirchen, , Germany
Universitätsklinikum Giessen
Giessen, , Germany
Herzzentrum Göttingen
Göttingen, , Germany
Uniklinik Hamburg-Eppendorf
Hamburg, , Germany
Universitätsklinikum Kiel
Kiel, , Germany
Park-Krankenhaus Leipzig
Leipzig, , Germany
Universitätsklinikum Lübeck
Lübeck, , Germany
Universitätsklinikum Mainz
Mainz, , Germany
Klinikum E. v. Bergmann Potsdam
Potsdam, , Germany
Universitätsklinikum Rostock
Rostock, , Germany
Hegau-Klinikum Singen
Singen, , Germany
Countries
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References
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Wilhelm MP, Schlensak C, Hoh A, Knipping L, Mangold G, Dallmeier Rojas D, Beyersdorf F. Controlled reperfusion using a simplified perfusion system preserves function after acute and persistent limb ischemia: a preliminary study. J Vasc Surg. 2005 Oct;42(4):690-4. doi: 10.1016/j.jvs.2005.05.055.
Other Identifiers
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S 991228
Identifier Type: -
Identifier Source: org_study_id