CRAIL - Controlled Reperfusion of the Acutely Ischemic Limb

Lower Extremity Ischemia Clinical Trial

— CRAIL  

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00567801
• Other study ID #: S 991228
• Status: Terminated
• Phase: Phase 3
• First received: December 4, 2007
• Last updated: July 25, 2008
• Start date: September 2002
• Est. completion date: September 2010

Study information

• Verified date: July 2008
• Source: University Hospital Freiburg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 250
• Est. completion date: September 2010
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lower Extremity Ischemia

Intervention

Procedure:
• conventional embolectomy/thrombectomy

• embolectomy/thrombectomy with controlled reperfusion

Locations

Country	Name	City	State
Austria	Universität Innsbruck	Innsbruck
Austria	St. Johanns-Spital Salzburg	Salzburg
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	University Medical Center Freiburg	Freiburg	Baden-Württemberg
Germany	St. Marien-Hospital Buer, Gelsenkirchen	Gelsenkirchen
Germany	Universitätsklinikum Giessen	Giessen
Germany	Herzzentrum Göttingen	Göttingen
Germany	Uniklinik Hamburg-Eppendorf	Hamburg
Germany	Städtisches Klinikum Karlsruhe	Karlsruhe	Baden-Württemberg
Germany	Universitätsklinikum Kiel	Kiel
Germany	Klinikum Lahr	Lahr	Baden-Württemberg
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	Klinikum Villingen-Schwenningen	Villingen-Schwenningen	Baden-Württemberg

Sponsors (5)

Lead Sponsor	Collaborator
University Hospital Freiburg	Dr. Köhler Chemie (Alsbach-Hähnlein, Germany), GEA (Frederiksberg, Denmark), HP-Medica (Augsburg, Germany), Kardialagut (München, Germany)

Countries where clinical trial is conducted

Austria,  Germany, 

References & Publications (1)

Wilhelm MP, Schlensak C, Hoh A, Knipping L, Mangold G, Dallmeier Rojas D, 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amputation-free survival		28 days	No
Secondary	Neurological status (motor function, sensor function) of ischemic limb		4 weeks	No
Secondary	Systemic complications in both therapy groups		4 weeks	Yes
Secondary	Tolerance of reperfusion solution		4 weeks	Yes
Secondary	Lethality		12 months	No