CRAIL - Controlled Reperfusion of the Acutely Ischemic Limb - Full Text View

Sponsors and Collaborators:	University Hospital Freiburg 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

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 III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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
1: Active Comparator conventional embolectomy/thrombectomy	Procedure: conventional embolectomy/thrombectomy
2: Experimental 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
St. Johannes-Hospital Dortmund
Dortmund, Germany
Marienhospital Altenessen
Essen, Germany
Universitätsklinikum Giessen
Giessen, Germany
Universitätsklinikum Lübeck
Lübeck, Germany
Universitätsklinikum Frankfurt
Frankfurt, Germany
Kreisklinikum Donaueschingen
Donaueschingen, Germany
Park-Krankenhaus Leipzig
Leipzig, Germany
Herzzentrum Göttingen
Göttingen, Germany
Universitätsklinikum Kiel
Kiel, Germany
Hegau-Klinikum Singen
Singen, Germany
St. Marien-Hospital Buer, Gelsenkirchen
Gelsenkirchen, Germany
Klinikum E. v. Bergmann Potsdam
Potsdam, Germany
Universitätsklinikum Mainz
Mainz, Germany
Universitätsklinikum Bonn
Bonn, Germany
Universitätsklinikum Rostock
Rostock, Germany
Uniklinik Hamburg-Eppendorf
Hamburg, Germany
Herzzentrum Bad Krozingen
Bad Krozingen, Germany
Germany, Baden-Württemberg
University Medical Center Freiburg
Freiburg, Baden-Württemberg, Germany
Klinikum Lahr
Lahr, Baden-Württemberg, Germany
Klinikum Villingen-Schwenningen
Villingen-Schwenningen, Baden-Württemberg, Germany
Städtisches Klinikum Karlsruhe
Karlsruhe, Baden-Württemberg, 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:

Wilhelm MP, Schlensak C, Hoh A, Knipping L, Mangold G, Rojas DD, 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.

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

Keywords provided by University Hospital Freiburg:

Lower Extremity
Ischemia

Study placed in the following topic categories:

Ischemia

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009