Factor XIII in patients with alcohol abuse disorder

ISRCTN ISRCTN41162940
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

Chariteplatz 1
Berlin
10117
Germany

+49 (0)30 450 55 10 01
claudia.spies@charite.de

Study information

Study designProspective randomised placebo-controlled double-blinded two-arm single-centre trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleCan 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 acronymFactor XIII
Study objectives1. 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) studiedChronic alcohol use disorder
InterventionThere 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 typeDrug
Pharmaceutical study type(s)
PhasePhase IV
Drug / device / biological / vaccine name(s)Factor XIII
Primary outcome measureModified factor XIII levels in peripherial blood samples and immune suppression, examined at six measure points during hospital stay.
Secondary outcome measures1. 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 date20/10/2005
Completion date18/01/2010
Reason abandoned (if study stopped)Objectives no longer viable

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants80
Key inclusion criteriaCurrent 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 criteria1. 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 enrolment29/08/2007
Date of final enrolment18/01/2010

Locations

Countries of recruitment

  • Germany

Study participating centre

Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin)
Berlin
10117
Germany

Sponsor information

Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
Hospital/treatment centre

Chariteplatz 1
Berlin
10117
Germany

anaesthesie-virchow-klinikum@charite.de
http://www.charite.de/
ROR logo https://ror.org/001w7jn25

Funders

Funder type

Hospital/treatment centre

Charité Universitätsmedizin Berlin
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
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
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