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

Primary Purpose

Lower Extremity Ischemia

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
conventional embolectomy/thrombectomy
embolectomy/thrombectomy with controlled reperfusion
Sponsored by
University Hospital Freiburg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lower Extremity Ischemia focused on measuring Lower Extremity, Ischemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

conventional embolectomy/thrombectomy

embolectomy/thrombectomy with controlled reperfusion

Outcomes

Primary Outcome Measures

Amputation-free survival

Secondary Outcome Measures

Neurological status (motor function, sensor function) of ischemic limb
Systemic complications in both therapy groups
Tolerance of reperfusion solution
Lethality

Full Information

First Posted
December 4, 2007
Last Updated
July 25, 2008
Sponsor
University Hospital Freiburg
Collaborators
Dr. Köhler Chemie (Alsbach-Hähnlein, Germany), HP-Medica (Augsburg, Germany), GEA (Frederiksberg, Denmark), Kardialagut (München, Germany)
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1. Study Identification

Unique Protocol Identification Number
NCT00567801
Brief Title
CRAIL - Controlled Reperfusion of the Acutely Ischemic Limb
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2008
Overall Recruitment Status
Terminated
Study Start Date
September 2002 (undefined)
Primary Completion Date
September 2009 (Anticipated)
Study Completion Date
September 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital Freiburg
Collaborators
Dr. Köhler Chemie (Alsbach-Hähnlein, Germany), HP-Medica (Augsburg, Germany), GEA (Frederiksberg, Denmark), Kardialagut (München, Germany)

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Extremity Ischemia
Keywords
Lower Extremity, Ischemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
conventional embolectomy/thrombectomy
Arm Title
2
Arm Type
Experimental
Arm Description
embolectomy/thrombectomy with controlled reperfusion
Intervention Type
Procedure
Intervention Name(s)
conventional embolectomy/thrombectomy
Intervention Type
Procedure
Intervention Name(s)
embolectomy/thrombectomy with controlled reperfusion
Primary Outcome Measure Information:
Title
Amputation-free survival
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Neurological status (motor function, sensor function) of ischemic limb
Time Frame
4 weeks
Title
Systemic complications in both therapy groups
Time Frame
4 weeks
Title
Tolerance of reperfusion solution
Time Frame
4 weeks
Title
Lethality
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Friedhelm Beyersdorf, Prof. Dr.
Organizational Affiliation
Department of Cardiovascular Surgery, University Medical Center Freiburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universität Innsbruck
City
Innsbruck
Country
Austria
Facility Name
St. Johanns-Spital Salzburg
City
Salzburg
Country
Austria
Facility Name
University Medical Center Freiburg
City
Freiburg
State/Province
Baden-Württemberg
Country
Germany
Facility Name
Städtisches Klinikum Karlsruhe
City
Karlsruhe
State/Province
Baden-Württemberg
Country
Germany
Facility Name
Klinikum Lahr
City
Lahr
State/Province
Baden-Württemberg
Country
Germany
Facility Name
Klinikum Villingen-Schwenningen
City
Villingen-Schwenningen
State/Province
Baden-Württemberg
Country
Germany
Facility Name
Herzzentrum Bad Krozingen
City
Bad Krozingen
Country
Germany
Facility Name
Universitätsklinikum Bonn
City
Bonn
Country
Germany
Facility Name
Kreisklinikum Donaueschingen
City
Donaueschingen
Country
Germany
Facility Name
St. Johannes-Hospital Dortmund
City
Dortmund
Country
Germany
Facility Name
Marienhospital Altenessen
City
Essen
Country
Germany
Facility Name
Universitätsklinikum Frankfurt
City
Frankfurt
Country
Germany
Facility Name
St. Marien-Hospital Buer, Gelsenkirchen
City
Gelsenkirchen
Country
Germany
Facility Name
Universitätsklinikum Giessen
City
Giessen
Country
Germany
Facility Name
Herzzentrum Göttingen
City
Göttingen
Country
Germany
Facility Name
Uniklinik Hamburg-Eppendorf
City
Hamburg
Country
Germany
Facility Name
Universitätsklinikum Kiel
City
Kiel
Country
Germany
Facility Name
Park-Krankenhaus Leipzig
City
Leipzig
Country
Germany
Facility Name
Universitätsklinikum Lübeck
City
Lübeck
Country
Germany
Facility Name
Universitätsklinikum Mainz
City
Mainz
Country
Germany
Facility Name
Klinikum E. v. Bergmann Potsdam
City
Potsdam
Country
Germany
Facility Name
Universitätsklinikum Rostock
City
Rostock
Country
Germany
Facility Name
Hegau-Klinikum Singen
City
Singen
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
16242556
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.
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CRAIL - Controlled Reperfusion of the Acutely Ischemic Limb

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