Long-term follow-up study in liver resection patients receiving a haemoglobin-based oxygen carrier
© Current Science Ltd 1997
Published: 1 March 1997
Since improvement in purification of stroma-free haemoglobin solutions enables the production of cell-free oxygen carriers which are free of toxic side-effects on liver and kidneys, clinical interest in such material has been aroused during the last years. Animal models have shown that ultrapurified polymerized bovine haemoglobin (HBOC-201) is free of severe hepato-renal side-effects and provides excellent tissue oxygenation [1,2,3]. The present prospective study was designed to examine safety and tolerance of HBOC-201 applied during haemodilution in patients prior to liver resection.
After approval of the ethics committee and written informed consent, 12 patients (6 male and 6 female, mean age 59 ± 10 years) undergoing elective liver resection randomly received either 0.4 g/kg HBOC-201 (Biopure MA, group 1) or 3 ml/kg of hydroxyethylstarch 70,000/0.5 (B Braun, FRG, group 2) after autologous blood donation of 1 l. Blood chemistry, haematology, coagulation profiles, urinalysis and immunologic samples were taken on the day before surgery, on days 1-4, 7 and 14 after surgery as well as 3 months after the operation. All values were statistically analysed using ANOVA and Mann-Whitney U-test with P < 0.05 considered as significant.
Demographic characteristics, blood loss, time of operation and duration of hospitalization did not differ between groups. No allergic or other adverse reactions occurred during infusion of HBOC-201. The mean intravascular half-life of HBOC-201 was 8.5 h, no free haemoglobin was detectable in urine over time. Due to the operation, all patients of both groups showed temporary but reversible rises of liver enzymes and bilirubin but no changes in coagulation profiles or creatine. No IgE antibodies to HBOC-201 were seen. The Figure shows the mean concentrations of IgG to HBOC-201.
The single application of a moderate dose of HBOC-201 was well tolerated in patients undergoing liver resection surgery. However, in spite of the very low IgG titers 14 days after the application of HBOC-201, it remains unclear at the moment if a second administration of the material may cause any immunological reactions.