Trial document





This trial has been registered retrospectively.
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  DRKS00000579

Trial Description

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Title

CRAIL-study: Prospektive randomized multicenter study for optimization of therapy of the acute ischemic limb by controlled reperfusion.

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Patients with an acute ischemia of a leg undergo surgical opening of the occluded blood vessel. The study compares the subsequent controlled reperfusion to conventional reperfusion.

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Brief Summary in Scientific Language

The multicenter prospective randomized CRAIL-study (Controlled Reperfusion of the Acuely Ischemic Limb) compares conventional embolectomy/thrombectomy with embolectomy/thrombectomy accompanied by controlled reperfusion for acute arterial occlusion of the lower extremities.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00000579
  •   2010/10/15
  •   2007/02/01
  •   yes
  •   Approved
  •   124/01, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   NCT00567801  (ClinicalTrials.gov)
  •   UKF001013  (Register klinischer Studien des Universitätsklinikums Freiburg)
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Health Condition or Problem studied

  •   I74.3 -  Embolism and thrombosis of arteries of lower extremities
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Interventions/Observational Groups

  •   Conventional embolectomy/thrombectomy with uncontrolled reperfusion
  •   Embolectomy/thrombectomy with controlled reperfusion
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   III
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Primary Outcome

survival free of amputation (after 4 weeks)

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Secondary Outcome

1. neurological status (motor function, sensation) of the affected limb after 4 weeks
2. frequency of systemic complications in both groups
3. tolerance of the reperfusion solution
4. mortality after 6 and 12 months

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Countries of Recruitment

  •   Germany
  •   Austria
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2002/09/30
  •   250
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- patients > 18 years of age
- arterial occlusion in one or both of the lower extremities concurrent with acute ischemia causing decompensation ( Rutherford Stage IIA-III)

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Exclusion Criteria

- patients who have undergone a recent, or current attempt to revascularize (for example: lysis therapy)
- patients with a known A. poplitea aneurysma in the limb concerned
- patients with severe heart failure (NYHA IV)
- patients with terminal kidney failure (creatinine > 10mg/dl) or undergoing dialysis, kidney transplant
- allopurinol intolerance
- allergy to any of the components in the reperfusion solution
- current participation in a clinical trial (or within the last 30 days)
- pregnant patients, or those currently breastfeeding
- other conditions or circumstances likely to lead to poor treatment adherence (i.e., drug dependency, no fixed abode)

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Addresses

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    • Universitätsklinikum Freiburg
    • Hugstetter Strasse 49
    • 79095  Freiburg
    • Germany
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    • Universitäts-Herzzentrum Freiburg-Bad Krozingen Klinik für Herz- und Gefäßchirurgie
    • Mr.  Professor  Friedhelm  Beyersdorf 
    • Hugstetter Strasse 55
    • 79106  Freiburg
    • Germany
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    • Universitaets-Herzzentrum Freiburg - Bad Krozingen Klinik für Herz- und Gefaesschirurgie
    • Mr.  Professor  Friedhelm  Beyersdorf 
    • Hugstetter Strasse 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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    • Firma Dr. F. Köhler Chemie GmbH
    • Neue Bergstraße 3 - 7
    • 64665  Alsbach-Hähnlein
    • Germany
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    •   +49 (0) 6257 509 0
    •   +49 (0) 6257 509 46
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    • HP-Medica
    • Bahnhofstr. 30
    • 86150  Augsburg
    • Germany
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    • Kardialgut
    • Paul-Heyse-Str. 19
    • 80336  München
    • Germany
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    • GEA Farmaceutisk Fabrik
    • Holger Danskes Vej 89
    • 2000  Frederiksberg
    • Denmark
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Status

  •   Recruiting stopped after recruiting started
  •   2009/01/13
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Trial Publications, Results and other Documents

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