CRAIL - Controlled Reperfusion of the Acutely Ischemic Limb (CRAIL)

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)

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.

Study Overview

• Status: Terminated
• Conditions: Lower Extremity Ischemia
• Intervention / Treatment: Procedure: conventional embolectomy/thrombectomy; Procedure: embolectomy/thrombectomy with controlled reperfusion

• Study Type: Interventional
• Enrollment (Anticipated): 250
• Phase: Phase 3

Contacts and Locations

Study Locations

• Austria
  • Innsbruck, Austria
    • Universität Innsbruck
  • Salzburg, Austria
    • St. Johanns-Spital Salzburg
• Germany
  • Bad Krozingen, Germany
    • Herzzentrum Bad Krozingen
  • Bonn, Germany
    • Universitätsklinikum Bonn
  • Donaueschingen, Germany
    • Kreisklinikum Donaueschingen
  • Dortmund, Germany
    • St. Johannes-Hospital Dortmund
  • Essen, Germany
    • Marienhospital Altenessen
  • Frankfurt, Germany
    • Universitatsklinikum Frankfurt
  • Gelsenkirchen, Germany
    • St. Marien-Hospital Buer, Gelsenkirchen
  • Giessen, Germany
    • Universitätsklinikum Gießen
  • Göttingen, Germany
    • Herzzentrum Gottingen
  • Hamburg, Germany
    • Uniklinik Hamburg-Eppendorf
  • Kiel, Germany
    • Universitätsklinikum Kiel
  • Leipzig, Germany
    • Park-Krankenhaus Leipzig
  • Lübeck, Germany
    • Universitätsklinikum Lübeck
  • Mainz, Germany
    • Universitätsklinikum Mainz
  • Potsdam, Germany
    • Klinikum E. v. Bergmann Potsdam
  • Rostock, Germany
    • Universitätsklinikum Rostock
  • Singen, Germany
    • Hegau-Klinikum Singen
  • Baden-Württemberg
    • Freiburg, Baden-Württemberg, Germany
      • University Medical Center Freiburg
    • Karlsruhe, Baden-Württemberg, Germany
      • Städtisches Klinikum Karlsruhe
    • Lahr, Baden-Württemberg, Germany
      • Klinikum Lahr
    • Villingen-Schwenningen, Baden-Württemberg, Germany
      • Klinikum Villingen-Schwenningen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; conventional embolectomy/thrombectomy	Procedure: conventional embolectomy/thrombectomy
Experimental: 2; embolectomy/thrombectomy with controlled reperfusion	Procedure: embolectomy/thrombectomy with controlled reperfusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Amputation-free survival	28 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Neurological status (motor function, sensor function) of ischemic limb	4 weeks
Systemic complications in both therapy groups	4 weeks
Tolerance of reperfusion solution	4 weeks
Lethality	12 months

Collaborators and Investigators

• Sponsor: University Hospital Freiburg
• Collaborators: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2002
• Primary Completion (Anticipated): September 1, 2009
• Study Completion (Anticipated): September 1, 2010

Study Registration Dates

• First Submitted: December 4, 2007
• First Submitted That Met QC Criteria: December 4, 2007
• First Posted (Estimate): December 5, 2007

Study Record Updates

• Last Update Posted (Estimate): July 28, 2008
• Last Update Submitted That Met QC Criteria: July 25, 2008
• Last Verified: July 1, 2008

More Information

Terms related to this study

• Keywords: Ischemia; Lower Extremity
• Additional Relevant MeSH Terms: Pathologic Processes; Ischemia
• Other Study ID Numbers: S 991228