Artikel
Comparison of the collagen haemostat Sangustop® versus a carrier-bound fibrin sealant during liver resection; An open, randomized, prospective, multicenter, trial
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Veröffentlicht: | 23. April 2012 |
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Introduction: A new collagen haemostat is expected to be as effective and safe as an established. The aim of this trial was to confirm the non-inferiority of the collagen haemostat Sangustop® versus the carrier-bound fibrin sealant Tachosil® in liver resection.
Material and methods: This trial was designed as an multicenter, randomized, surgical trial with 2 parallel groups. Patients were eligible for intra-operative randomization after elective liver resection and primary hemostasis. The primary end point was the frequency of patients achieving hemostasis after 3 minutes. Secondary endpoints were the frequencies at 5 and 10 minutes. Adverse events were collected to evaluate the safety of treatments.
Results: A total of 127 patients planned for an elective liver resection were enrolled in eight surgical centres. The proportion of patients with haemostasis after 3, 5, and after 10 minutes was not different between the study arm with Sangustop® and the comparator Tachosil®. In the Sangustop® arm 53 out of 61 patients (86.9%) reached haemostasis 3 minutes after application of the product compared to 52 out of 65 patients (80.0 %) in the Tachosil® arm. After 5 minutes the results were 93% vs. 95% and after 10 minutes 98% vs. 100% for Sangustop® and for Tachosil® respectively. Statistical analysis showed that Sangustop® treatment can be regarded as clinically non-inferior to the comparator device Tachosil®. The safety profile of the two tasted treatments were similar.
Conclusion: Sangustop® is not inferior to Tachosil® in obtaining effective intra-operative haemostasis in liver resection. Postoperative morbidity and mortality were similar between both.