CRAIL - Controlled Reperfusion of the Acutely Ischemic Limb

This study has been terminated.
Sponsor:
Collaborators:
Dr. Köhler Chemie (Alsbach-Hähnlein, Germany)
HP-Medica (Augsburg, Germany)
GEA (Frederiksberg, Denmark)
Kardialagut (München, Germany)
Information provided by:
University Hospital Freiburg
ClinicalTrials.gov Identifier:
NCT00567801
First received: December 4, 2007
Last updated: July 25, 2008
Last verified: July 2008
  Purpose

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 Intervention Phase
Lower Extremity Ischemia
Procedure: conventional embolectomy/thrombectomy
Procedure: embolectomy/thrombectomy with controlled reperfusion
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Further study details as provided by University Hospital Freiburg:

Primary Outcome Measures:
  • Amputation-free survival [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Neurological status (motor function, sensor function) of ischemic limb [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Systemic complications in both therapy groups [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • Tolerance of reperfusion solution [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • Lethality [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: September 2002
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
conventional embolectomy/thrombectomy
Procedure: conventional embolectomy/thrombectomy
Experimental: 2
embolectomy/thrombectomy with controlled reperfusion
Procedure: embolectomy/thrombectomy with controlled reperfusion

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • Abuse to drugs or alcohol
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00567801

Locations
Austria
Universität Innsbruck
Innsbruck, Austria
St. Johanns-Spital Salzburg
Salzburg, Austria
Germany
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)
Investigators
Principal Investigator: Friedhelm Beyersdorf, Prof. Dr. Department of Cardiovascular Surgery, University Medical Center Freiburg
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00567801     History of Changes
Other Study ID Numbers: S 991228
Study First Received: December 4, 2007
Last Updated: July 25, 2008
Health Authority: Germany: Ethics Commission

Keywords provided by University Hospital Freiburg:
Lower Extremity
Ischemia

Additional relevant MeSH terms:
Ischemia
Pathologic Processes

ClinicalTrials.gov processed this record on April 21, 2014