CRAIL - Controlled Reperfusion of the Acutely Ischemic Limb
This study has been terminated.
Sponsor:
University Hospital Freiburg
Collaborators:
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
First received: December 4, 2007
Last updated: July 25, 2008
Last verified: July 2008
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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) |
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 |
|---|---|
|
Active Comparator: 1
conventional embolectomy/thrombectomy
|
Procedure: conventional embolectomy/thrombectomy |
|
Experimental: 2
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 | |
| University Medical Center Freiburg | |
| Freiburg, Baden-Württemberg, Germany | |
| Städtisches Klinikum Karlsruhe | |
| Karlsruhe, Baden-Württemberg, Germany | |
| Klinikum Lahr | |
| Lahr, Baden-Württemberg, Germany | |
| Klinikum Villingen-Schwenningen | |
| Villingen-Schwenningen, Baden-Württemberg, 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 | |
| St. Marien-Hospital Buer, Gelsenkirchen | |
| Gelsenkirchen, Germany | |
| Universitätsklinikum Giessen | |
| Giessen, Germany | |
| Herzzentrum Göttingen | |
| Göttingen, Germany | |
| Uniklinik Hamburg-Eppendorf | |
| Hamburg, Germany | |
| Universitätsklinikum Kiel | |
| Kiel, 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 | |
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:
| ClinicalTrials.gov Identifier: | NCT00567801 History of Changes |
| Other Study ID Numbers: | S 991228 |
| Study First Received: | December 4, 2007 |
| Last Updated: | July 25, 2008 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by University Hospital Freiburg:
|
Lower Extremity Ischemia |
Additional relevant MeSH terms:
|
Ischemia Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013