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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 November 20, 2014