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

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
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 October 03, 2008

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