Factor XIII in patients with alcohol abuse disorder

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN41162940

Enrollment

Registered

2009-12-03

Start date

2007-08-29

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic alcohol use disorder Mental and Behavioural Disorders Mental and behavioural disorders due to use of alcohol

Interventions

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

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

participants are no longer being examined or treated.

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Modified factor XIII levels in peripherial blood samples and immune suppression, examined at six measure points during hospital stay.	—

Secondary

Measure	Time frame
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	—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026