Randomised, controlled multicentre-trial for the optimised therapy of the acutely ischaemic limb with controlled reperfusion

ISRCTN ISRCTN29807122
DOI https://doi.org/10.1186/ISRCTN29807122
ClinicalTrials.gov number NCT00567801
Secondary identifying numbers S 991228
Submission date
22/03/2004
Registration date
15/04/2004
Last edited
31/05/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Friedhelm Beyersdorf
Scientific

Department of Cardiovascular Surgery
University Hospital Freiburg
Hugstetterstr. 55
Freiburg
79106
Germany

Phone +49 761 2702818
Email beyers@chir.ukl.uni-freiburg.de

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific titleRandomised, controlled multicentre-trial for the optimised therapy of the acutely ischaemic limb with controlled reperfusion
Study acronymCRAIL
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedAcutely ischaemic limb
InterventionEmbolectomy/Thrombectomy vs controlled reperfusion after Embolectomy/Thrombectomy
Intervention typeOther
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/2004
Completion date31/12/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexNot Specified
Target number of participantsNot provided at time of registration
Total final enrolment174
Key inclusion criteria1. Patient >18 years
2. Acute arterial occlusion of one or both lower limbs (Rutherford IIa-III)
Key exclusion criteria1. Patients having undergone an attempt at recanalisation (Lyse etc.)
2. Heart failure (New York Heart Association [NYHA] IV)
3. Terminal kidney failure
4. Patients with a known aneurysm of the arteria poplitea
Date of first enrolment01/01/2004
Date of final enrolment31/12/2007

Locations

Countries of recruitment

  • Germany

Study participating centre

Department of Cardiovascular Surgery
Freiburg
79106
Germany

Sponsor information

University Hospital Freiburg (Germany)
Hospital/treatment centre

Department of Cardiovascular Surgery
University Hospital Freiburg
Hugstetterstr.55
Freiburg
79106
Germany

Phone +49 761 2702818
Email beyers@chir.ukl.uni-freiburg.de
Website http://www.uni-freiburg.de/index_en.php
ROR logo "ROR" https://ror.org/03vzbgh69

Funders

Funder type

Government

Deutsche Forschungsgemeinschaft, Bonn, Germany

No information available

Dr. Köhler-Chemie, Alsbach-Hähnlein, Germany

No information available

Local research commission, University hospital Freiburg, Germany

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Other publications preliminary study 01/10/2005 Yes No
Results article results 01/08/2013 31/05/2019 Yes No

Editorial Notes

31/05/2019: The following changes were made:
1. Publication reference added.
2. Total final enrolment added.
3. Clinicaltrials.gov number added.