Topical rhThrombin as an Adjunct to Hemostasis During Segmental Hepatectomy

Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2017
The study is a randomized, single‐blind,blank controlled phase 1&2 trial ,including 3 independent parts toevaluate the safety,efficacy and immunogenicity. The first part is ascending dose,blank control tolerability and safety study. The Starting doses from 500IU/ml to 1000IU/mL and 2000IU/mL to evaluate the safety,efficacy. The second part is randomized, single‐blind, blank controlled study to evaluate safety、efficacy and immunogenicity. Doses settings :1000IU/mL , 2000IU/mL and blank group which with absorbable collagen sponge when used. The third part is randomized, single‐blind, blank controlled study to evaluate safety、efficacy and immunogenicity. Doses settings :1000IU/mL , 2000IU/mL and blank group which directly sprayed on hemorrhagic point when used.
Epistemonikos ID: d84dda2d03dc20dbf97d9cb2018f03618536f306
First added on: May 21, 2024