Factor XIII in patients with alcohol abuse disorder
ISRCTN | ISRCTN41162940 |
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DOI | https://doi.org/10.1186/ISRCTN41162940 |
Secondary identifying numbers | N/A |
- Submission date
- 10/12/2008
- Registration date
- 03/12/2009
- Last edited
- 28/09/2015
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Claudia Spies
Scientific
Scientific
Chariteplatz 1
Berlin
10117
Germany
Phone | +49 (0)30 450 55 10 01 |
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claudia.spies@charite.de |
Study information
Study design | Prospective randomised placebo-controlled double-blinded two-arm single-centre trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
Scientific title | Can the infusion of factor XIII shorten the length of hospital stay in patients with chronic alcohol use disorder? A prospective, randomised, placebo-controlled trial |
Study acronym | Factor XIII |
Study objectives | 1. Chronic alcohol use leads to a variation of the pre- and post-operative plasma concentration of factor XIII 2. The application of factor XIII results in lower bleeding complications after surgery, less infections and impaired wound healing 3. Factor XIII can shorten the hospital stay in patients with chronic alcohol use disorder On 28/09/2015 the target number of participants was changed from 40 to 80. |
Ethics approval(s) | Ethics Committee of Charité - University Medicine Berlin, 08/07/2004 |
Health condition(s) or problem(s) studied | Chronic alcohol use disorder |
Intervention | There are five drug administration points, the duration of infusion takes about 20 minutes: 1. Pre-operative 2500 IE intravenous (i.v.) fibrogammin or placebo (NaCL 0.9% Lsg.) 2. Post-operative 1250 IE i.v. fibrogammin or placebo 3. First day post-operative 1250 IE i.v. fibrogammin or placebo 4. Second day post-operative 1250 IE i.v. fibrogammin or placebo 5. Third day post-operative 1250 IE i.v. fibrogammin or placebo Blood samples are taken 2 x pre-operatively (1 x before and after fibrogammin) and 1 x post-operatively and on the 1, 4, and 10 day post-operative; clinical evaluation of the patient (bleeding/wound/complications) every day. Please note that as of 22/10/2010 the status of this trial has been updated to "Completed". The end date of this trial was recorded as 18/01/2010. The originally anticipated end date was 20/10/2010. Please note that as of 28/09/2015 the status of this trial has been updated to “Stopped”: recruiting participants has halted prematurely and will not resume due to futility; participants are no longer being examined or treated. |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Phase IV |
Drug / device / biological / vaccine name(s) | Factor XIII |
Primary outcome measure | Modified factor XIII levels in peripherial blood samples and immune suppression, examined at six measure points during hospital stay. |
Secondary outcome measures | 1. Evaluation of peri-operative coagulation function and status - at six measure points during the hospital stay 2. Peri-operative incidence of bleeding complications and impaired wound healing, examined the whole time during hospital stay of the patient 3. Length of hospital stay |
Overall study start date | 20/10/2005 |
Completion date | 18/01/2010 |
Reason abandoned (if study stopped) | Objectives no longer viable |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 80 |
Key inclusion criteria | Current inclusion criteria as of 28/09/2015: 1. Aged greater than or equal to 18 years, either sex 2. Written informed consent of the patient 3. 40 patients without daily alcohol consumption and 40 patients with alcohol consumption more or equal to 60 g per day 4. Patients undergoing elective tumour resection in oropharyngeal region and elective orthopedic surgery Previous inclusion criteria: 1. Aged greater than or equal to 18 years, either sex 2. Written informed consent of the patient 3. Alcohol consumption more or equal to 60 g per day 4. Patients undergoing elective tumour resection in oropharyngeal region |
Key exclusion criteria | 1. Age under 18 years 2. No wiritten consent from patient 3. Liver cirrhosis (stage Child B or C) 4. Congenital or acquired coagulation disorders 5. Terminal renal insufficiency 6. Angina pectoris or congestive heart failure 7. Immune suppression 8. History of pulmonary embolism or deep venous thrombosis Added 28/09/2015: 9. Therapy with Anticoagulant of Vitamin-K-Antagonist-Type |
Date of first enrolment | 29/08/2007 |
Date of final enrolment | 18/01/2010 |
Locations
Countries of recruitment
- Germany
Study participating centre
Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin)
Berlin
10117
Germany
10117
Germany
Sponsor information
Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
Hospital/treatment centre
Hospital/treatment centre
Chariteplatz 1
Berlin
10117
Germany
anaesthesie-virchow-klinikum@charite.de | |
Website | http://www.charite.de/ |
https://ror.org/001w7jn25 |
Funders
Funder type
Hospital/treatment centre
Charité Universitätsmedizin Berlin
Private sector organisation / For-profit companies (industry)
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Medical School - Charité - University Medicine Berlin
- Location
- Germany
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |