Clinical trial NCT00567801: CRAIL - Controlled Reperfusion of the Acutely Ischemic Limb
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Lower Extremity Ischemia
Keywords: Lower Extremity
Ischemia
Lead sponsor: University Hospital Freiburg
Sponsor class: OTHER
Collaborators: name: Dr. Köhler Chemie (Alsbach-Hähnlein, Germany)
name: HP-Medica (Augsburg, Germany)
name: GEA (Frederiksberg, Denmark)
name: Kardialagut (München, Germany)
First posted: 2007-12-05
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Amputation-free survival
timeFrame: 28 days
Secondary outcomes:
measure: Neurological status (motor function, sensor function) of ischemic limb
timeFrame: 4 weeks
measure: Systemic complications in both therapy groups
timeFrame: 4 weeks
measure: Tolerance of reperfusion solution
timeFrame: 4 weeks
measure: Lethality
timeFrame: 12 months
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Universität Innsbruck
city: Salzburg
country: Austria
facility: St. Johanns-Spital Salzburg
city: Freiburg
country: Germany
facility: University Medical Center Freiburg
state: Baden-Württemberg
city: Karlsruhe
country: Germany
facility: Städtisches Klinikum Karlsruhe
state: Baden-Württemberg
city: Lahr
country: Germany
facility: Klinikum Lahr
state: Baden-Württemberg
city: Villingen-Schwenningen
country: Germany
facility: Klinikum Villingen-Schwenningen
state: Baden-Württemberg
city: Bad Krozingen
country: Germany
facility: Herzzentrum Bad Krozingen
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
city: Donaueschingen
country: Germany
facility: Kreisklinikum Donaueschingen
city: Dortmund
country: Germany
facility: St. Johannes-Hospital Dortmund
city: Essen
country: Germany
facility: Marienhospital Altenessen
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt
city: Gelsenkirchen
country: Germany
facility: St. Marien-Hospital Buer, Gelsenkirchen
city: Giessen
country: Germany
facility: Universitätsklinikum Giessen
city: Göttingen
country: Germany
facility: Herzzentrum Göttingen
city: Hamburg
country: Germany
facility: Uniklinik Hamburg-Eppendorf
city: Kiel
country: Germany
facility: Universitätsklinikum Kiel
city: Leipzig
country: Germany
facility: Park-Krankenhaus Leipzig
city: Lübeck
country: Germany
facility: Universitätsklinikum Lübeck
city: Mainz
country: Germany
facility: Universitätsklinikum Mainz
city: Potsdam
country: Germany
facility: Klinikum E. v. Bergmann Potsdam
city: Rostock
country: Germany
facility: Universitätsklinikum Rostock
city: Singen
country: Germany
facility: Hegau-Klinikum Singen
Study officials:
affiliation: Department of Cardiovascular Surgery, University Medical Center Freiburg
name: Friedhelm Beyersdorf, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1016/j.jvs.2005.05.055.