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 (NCT) | NCT00567801 |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | S 991228 |
| Sponsor | University Hospital Freiburg (Germany) |
| Funders | Deutsche Forschungsgemeinschaft, Bonn, Germany, Dr. Köhler-Chemie, Alsbach-Hähnlein, Germany, Local research commission, University hospital Freiburg, Germany |
- 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
Scientific
Department of Cardiovascular Surgery
University Hospital Freiburg
Hugstetterstr. 55
Freiburg
79106
Germany
| Phone | +49 761 2702818 |
|---|---|
| beyers@chir.ukl.uni-freiburg.de |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Randomised, controlled multicentre-trial for the optimised therapy of the acutely ischaemic limb with controlled reperfusion |
| Study acronym | CRAIL |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Acutely ischaemic limb |
| Intervention | Embolectomy/Thrombectomy vs controlled reperfusion after Embolectomy/Thrombectomy |
| Intervention type | Other |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Total final enrolment | 174 |
| Key inclusion criteria | 1. Patient >18 years 2. Acute arterial occlusion of one or both lower limbs (Rutherford IIa-III) |
| Key exclusion criteria | 1. 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 enrolment | 01/01/2004 |
| Date of final enrolment | 31/12/2007 |
Locations
Countries of recruitment
- Germany
Study participating centre
Department of Cardiovascular Surgery
Freiburg
79106
Germany
79106
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2013 | 31/05/2019 | Yes | No |
| Other publications | preliminary study | 01/10/2005 | 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.
