Abstract
Severe acute inflammation in chronic inflammatory bowel disease is associated with
large wound areas and ulcerations that show spontaneous hemorrhage or marked friability.
Therefore, an enormous potential of hemostasis and wound healing is required. Coagulation
studies demonstrate a deficiency of factor XIII that is important for both clot formation
and wound healing. Consequently, the substitution of factor XIII may be beneficial;
the first case reports present favorable clinical results.
In a prospective pilot study, we treated 12 patients with therapy-resistant ulcerative
colitis. The colitis activity index (CAI) and the endoscopic score (ES) according
to Rachmilewitz were elevated; all patients suffered from hematochezia. After substitution
therapy with factor XIII concentrate (1,250 U/d) the stool frequency dropped and no
further hematochezia was detected. The CAI and the ES declined highly significantly.
Because of these encouraging results two placebo-controlled multicenter trials have
been initiated. In the first study, patients with acute stage of ulcerative colitis
associated with severe intestinal blood loss are treated with two different dosages
of factor XIII concentrate (1,250 and 500 U/d, respectively) or placebo for 10 days.
In the second trial, patients with therapyresistant ulcerative colitis with a lack
of remission in spite of a consequent therapy for 2 weeks are included; factor XIII
concentrate or placebo is administered for 10 days. The aim of both trials is an end
of intestinal bleeding and the fostering of a more effective wound-healing process.
Key words:
Factor XIII substitution - chronic inflammatory bowel diseases - ulcerative colitis
- factor XIII concentrate