liver transplantation
Conditions
Interventions
Trade Name: SERALB-125
Pharmaceutical Form: Solution for injection
Sponsors
Stockholm County Council, Karolinska University Hospital Huddinge, Department of Anesthesiology and Intensive Care
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients undergoing liver transplantation • Males and females = 40 years • Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: • Allergy to the investigational medical product • Pregnancy or breast feeding patients • Participation in other studies involving radiation or the use of stable isotopes within 30 days • Bleeding > 5000 mL • Re-transplantation, graft size reduction, or split liver • Continuous renal replacement therapy • Other circumstance that makes the investigator judge patient participation unsuitable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To find if and to what extent albumin is sequestered from the blood stream during and after liver transplantation;Secondary Objective: To explore the recovery of liver protein synthesis after liver transplantation;Primary end point(s): Cumulative perioperative albumin shift assessed by albumin mass balance ;Timepoint(s) of evaluation of this end point: Measurements will begin in connection with start of anesthesia (baseline). The primary endpoint is assessed at the end of the surgical procedure (liver transplantation) and 48-72 hours later | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Albumin synthesis rate (fractional and absolute), fibrinogen synthesis rate (fractional and absolute), plasma albumin, plasma volume, transcapillary escape rate of albumin;Timepoint(s) of evaluation of this end point: plasma albumin: from start of anesthesia until 72 hours after end of surgery. all other secondary endpoints during 48-72 hours after end of surgery. | — |
Countries
Sweden
Contacts
Public ContactDept. of Anesthesiology
Karolinska Institutet, Institution of Clinical Science Intervention and Technology (CLINTEC)
Outcome results
None listed