CRAIL - Controlled Reperfusion of the Acutely Ischemic Limb (CRAIL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00567801
Recruitment Status : Terminated
First Posted : December 5, 2007
Last Update Posted : July 28, 2008
Dr. Köhler Chemie (Alsbach-Hähnlein, Germany)
HP-Medica (Augsburg, Germany)
GEA (Frederiksberg, Denmark)
Kardialagut (München, Germany)
Information provided by:
University Hospital Freiburg

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.

Condition or disease Intervention/treatment Phase
Lower Extremity Ischemia Procedure: conventional embolectomy/thrombectomy Procedure: embolectomy/thrombectomy with controlled reperfusion Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : September 2002
Estimated Primary Completion Date : September 2009
Estimated Study Completion Date : September 2010

Arm Intervention/treatment
Active Comparator: 1
conventional embolectomy/thrombectomy
Procedure: conventional embolectomy/thrombectomy
Experimental: 2
embolectomy/thrombectomy with controlled reperfusion
Procedure: embolectomy/thrombectomy with controlled reperfusion

Primary Outcome Measures :
  1. Amputation-free survival [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Neurological status (motor function, sensor function) of ischemic limb [ Time Frame: 4 weeks ]
  2. Systemic complications in both therapy groups [ Time Frame: 4 weeks ]
  3. Tolerance of reperfusion solution [ Time Frame: 4 weeks ]
  4. Lethality [ Time Frame: 12 months ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  • Abuse to drugs or alcohol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00567801

Universität Innsbruck
Innsbruck, Austria
St. Johanns-Spital Salzburg
Salzburg, Austria
University Medical Center Freiburg
Freiburg, Baden-Württemberg, Germany
Städtisches Klinikum Karlsruhe
Karlsruhe, Baden-Württemberg, Germany
Klinikum Lahr
Lahr, Baden-Württemberg, Germany
Klinikum Villingen-Schwenningen
Villingen-Schwenningen, Baden-Württemberg, 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
Sponsors and Collaborators
University Hospital Freiburg
Dr. Köhler Chemie (Alsbach-Hähnlein, Germany)
HP-Medica (Augsburg, Germany)
GEA (Frederiksberg, Denmark)
Kardialagut (München, Germany)
Principal Investigator: Friedhelm Beyersdorf, Prof. Dr. Department of Cardiovascular Surgery, University Medical Center Freiburg

Publications: Identifier: NCT00567801     History of Changes
Other Study ID Numbers: S 991228
First Posted: December 5, 2007    Key Record Dates
Last Update Posted: July 28, 2008
Last Verified: July 2008

Keywords provided by University Hospital Freiburg:
Lower Extremity

Additional relevant MeSH terms:
Pathologic Processes