CRAIL - Controlled Reperfusion of the Acutely Ischemic Limb

• Sponsor: University Hospital Freiburg (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00567801
• Collaborator: Dr. Köhler Chemie (Alsbach-Hähnlein, Germany) (Other), HP-Medica (Augsburg, Germany) (Other), GEA (Frederiksberg, Denmark) (Other), Kardialagut (München, Germany) (Other)
• Enrollment: 250
• Locations: 23
• Arms: 2
• Duration (Months): 96
• Patients Per Site: 10.9
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lower Extremity Ischemia	Procedure: conventional embolectomy/thrombectomy; Procedure: embolectomy/thrombectomy with controlled reperfusion	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 250 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Sep 1, 2002
• Anticipated Primary Completion Date: Sep 1, 2009
• Anticipated Study Completion Date: Sep 1, 2010

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Amputation-free survival [28 days]

Secondary Outcome Measures

1. Neurological status (motor function, sensor function) of ischemic limb [4 weeks]

2. Systemic complications in both therapy groups [4 weeks]

3. Tolerance of reperfusion solution [4 weeks]

4. Lethality [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Universität Innsbruck	Innsbruck		Austria
2	St. Johanns-Spital Salzburg	Salzburg		Austria
3	University Medical Center Freiburg	Freiburg	Baden-Württemberg	Germany
4	Städtisches Klinikum Karlsruhe	Karlsruhe	Baden-Württemberg	Germany
5	Klinikum Lahr	Lahr	Baden-Württemberg	Germany
6	Klinikum Villingen-Schwenningen	Villingen-Schwenningen	Baden-Württemberg	Germany
7	Herzzentrum Bad Krozingen	Bad Krozingen		Germany
8	Universitätsklinikum Bonn	Bonn		Germany
9	Kreisklinikum Donaueschingen	Donaueschingen		Germany
10	St. Johannes-Hospital Dortmund	Dortmund		Germany
11	Marienhospital Altenessen	Essen		Germany
12	Universitätsklinikum Frankfurt	Frankfurt		Germany
13	St. Marien-Hospital Buer, Gelsenkirchen	Gelsenkirchen		Germany
14	Universitätsklinikum Giessen	Giessen		Germany
15	Herzzentrum Göttingen	Göttingen		Germany
16	Uniklinik Hamburg-Eppendorf	Hamburg		Germany
17	Universitätsklinikum Kiel	Kiel		Germany
18	Park-Krankenhaus Leipzig	Leipzig		Germany
19	Universitätsklinikum Lübeck	Lübeck		Germany
20	Universitätsklinikum Mainz	Mainz		Germany
21	Klinikum E. v. Bergmann Potsdam	Potsdam		Germany
22	Universitätsklinikum Rostock	Rostock		Germany
23	Hegau-Klinikum Singen	Singen		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

Study Documents (Full-Text)

None provided.

More Information

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.

• ClinicalTrials.gov Identifier: NCT00567801
• Other Study ID Numbers: S 991228
• First Posted: Dec 5, 2007
• Last Update Posted: Jul 28, 2008
• Last Verified: Jul 1, 2008

• Keywords provided by , ,: Lower Extremity; Ischemia
• Additional relevant MeSH terms: Ischemia

Study Results

No Results Posted as of Jul 28, 2008