Contact information
Type
Scientific
Primary contact
Prof Claudia Spies
ORCID ID
Contact details
Chariteplatz 1
Berlin
10117
Germany
+49 (0)30 450 55 10 01
claudia.spies@charite.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
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
Acronym
Factor XIII
Study hypothesis
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
Ethics Committee of Charité - University Medicine Berlin, 08/07/2004
Study design
Prospective randomised placebo-controlled double-blinded two-arm single-centre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Phase IV
Drug names
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 trial start date
20/10/2005
Overall trial end date
18/01/2010
Reason abandoned (if study stopped)
Objectives no longer viable
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
80
Participant 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
Recruitment start date
29/08/2007
Recruitment end date
18/01/2010
Locations
Countries of recruitment
Germany
Trial participating centre
Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin)
Berlin
10117
Germany
Sponsor information
Organisation
Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
Sponsor details
Chariteplatz 1
Berlin
10117
Germany
-
anaesthesie-virchow-klinikum@charite.de
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Charité Universitätsmedizin Berlin
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
For-profit companies (industry)
Location
Germany
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list