Influence of postoperative vaccination (Mutagrip) versus and intravenous infusion of a leucocyte multiplying hormone (GM-CSF) in immune-compromised patients undergoing pancreatic or esophageal operation on the course of immunosuppression and the postoperative infection rate.

• Conditions: Post-operative immunological stimulation in severe immune suppression. The study population is made up of adult, which are able to give their inform consent by their own. The patients are undergoing elective esophageal resection or pancreas resection. Both men and women should enrolled in the clinical trial. The participants included in the clinical trial will not be selected with regard to their sex. The clinical trial is a pilot study.; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2007-003111-31-DE
• Lead Sponsor: Charité - Universitaetsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05-16
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- HLA-DR expression on monozytes = 10.000 antigens/monocyte on the first postoperative day
- elective pancreas resection or esophagus resection,
- male or female subjects, aged =18,
- Written informed consent,
- negative pregnancy test (ßHCG in urine),
- women of childbearing age with highly effective contraception (PEARL-Index < 1%) or > 2 years postmenopausal,
- no participation in another investigational drug trial during the present clinical trial;
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

- HLA-DR expression on monocytes > 10.000 antigens/monocyte on the first postoperative day
- missing informed consent,
- aged <18,
- missing willingness for storage and transfer of pseudonymised medical data related to the clinical trial,
- persons who are detained officially or legally to an official institution,
- participation in another investigational drug trial,
- employee of Charité
- pregnancy (positive for ßHCG in blood)
- lactation
- female patients with reproductive potential without highly effective contraception
- congenital or acquired blood disease
- chemo- or radiotherapy within last 28 days
- leukemia
- emergency operations
- detected infections within last 7 days before operation
- positive for hepatitis B/C
- positive for HIV
- patients reacting allergic or sensitive to active pharmaceutical ingredients, to other components or to possible contaminations of the investigational new drug (or known specific allergic reaction)
- autoimmune diseases
- taking of immunosuppressives
- untreated arrhythmia
- instable angina pectoris
- symptomatic congenital heart defect
- thrombosis and thrombembolic events in clinical anamnesis
- Laboratory parameters:
- platelets = 100.000/µl
- neutrophiles = 1.500/µl
- hemoglobin = 8g/dl
- bilirubin > 2g/dl
- creatinin > 1,5g/dl
- AST/ALT > 90U/l

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified