Condition category
Mental and Behavioural Disorders
Date applied
10/12/2008
Date assigned
03/12/2009
Last edited
28/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.charite.de/

Funders

Funder type

Hospital/treatment centre

Funder name

Charité Universitätsmedizin Berlin

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes