Factor XIII-mediated inhibition of fibrinolysis and venous leg ulcers
Densitometric analysis shows an accelerated healing rate and a significantly diminished lesional fibrinolytic activity in patients with venous leg ulcers treated topically with the fibrin-stabilising factor XIII compared with controls.
Lack of clinical efficacy of additional factor XIII treatment in patients with steroid refractory colitis. The Factor XIII Study Group
Zeitschrift fur Gastroenterologie. 1999;37((10):):999-1004.
Patients with active ulcerative colitis have decreased levels of factor XIII (FXIII) activity, which is important for woundhealing. Recent uncontrolled studies claimed a beneficial effect of Factor XIII on clinical symptoms of ulcerative colitis, in particular intestinal bleeding. The objective of this trial was to evaluate the benefits of additional FXIII treatment in steroid-refractory patients with ulcerative colitis in a prospective, double blind, placebo-controlled study. A total of 28 patients were enrolled between October 1994 and January 1997. Primary objective of this study was the time until cessation of visible intestinal bleeding with 14 days after the start of treatment. Patients were treated for ten days either by i.v. application of FXIII concentrate or by placebo. The analysis of the primary efficacy criterion, cessation of intestinal bleeding, by a planned interim analysis showed no significant differences between the treatment groups (p = 0.8). This resulted in the termination of the study. The same applied to the CAI score. No patient in both treatment groups reached remission according to the colo-/-sigmoidoscopy score. Due to the high number of patients (16 of 28) who had to be excluded from the per-protocol analysis (e.g. changes to the concomitant medication) only the intention-to-treat population was analyzed. Overall the study showed no beneficial effect of additional FXIII treatment on active steroid-refractory ulcerative colitis. These results do not confirm previous open label studies which had reported a significant improvement of clinical symptoms.
Blood coagulation findings and the efficacy of factor XIII concentrate in premature infants with intracranial hemorrhages
Thrombosis Research. 1990;57((5):):755-63.
Coagulation findings were examined in 55 cases of neonatal intracranial hemorrhages (ICH). Marked decreases of the platelet count, fibrinogen, factor XIII (F XIII) activity, were observed in these cases. However, the relatively mild increases in the alpha 2-plasmin inhibitor activity, alpha 2-plasmin inhibitor.plasmin complex and fibrin/fibrinogen degradation products level were observed and only about one third of the cases showed abnormal values. In consideration of these coagulation findings, fifty-eight cases of premature infants were randomly divided into a treated group with a F XIII concentrate and a non-treated group. Thirty cases were administered within 6 hours after delivery to investigate the preventive effects against intraventricular hemorrhages (IVH). Compared in frequencies between both groups limited to the cases with a high risk of IVH, the frequency in the treated group was two out of 13 (15.4%), significantly low (p less than 0.05), while it was six out of eight cases (75.0%) in the non-treated group. From these results it was concluded that a F XIII concentrate is effective in the prophylaxis of IVH in premature infants.
Treatment of progressive systemic sclerosis using factor XIII
A double-blind, randomized crossover trial was carried out in 25 patients with progressive systemic sclerosis to compare the effectiveness and tolerability of treatment with Factor XIII with that of placebo. Patients received twice daily intravenous injections of either Factor XIII or placebo for 3 weeks and, after a wash-out period of 6 weeks, were crossed over to the alternative medication for a further 3 weeks. Assessments made by the physician and patients at the end of each treatment period indicated that Factor XIII was significantly better than placebo in improving the cutaneous manifestations of the disease and these opinions were supported by the significant improvement in the function index which was used to assess the degree of motor disability. Both local and general tolerability of Factor XIII treatment was good and there were no adverse reports.