title: A multicenter, phase III trial of hemocoagulase Agkistrodon: hemostasis, coagulation, and safety in patients undergoing abdominal surgery.
abstract: BACKGROUND
  Hemocoagulase Agkistrodon for injection is a single component thrombin which has passed phases I and II clinical trials. The purpose of this phase III clinical trial was to evaluate the effect of Hemocoagulase Agkistrodon on hemostasis and coagulation in abdominal skin and subcutaneous incisions and to assess the safety of this agent in surgical patients.
  
  
  METHODS
  This is a phase III, prospective, randomized, double-blind, and controlled multicenter clinical trial including 432 consecutive patients randomized into either a study group (injected with hemocoagulase Agkistrodon at 2 U, n = 324) or a control group (injected with hemocoagulase Atrox, n = 108). The hemostatic time, hemorrhagic volume, hemorrhagic volume per unit area, blood coagulation, and adverse events were measured and compared between the two groups.
  
  
  RESULTS
  The mean hemostatic time in the study group was (36.8 +/- 18.7) seconds; the hemorrhagic volume was (3.77 +/- 3.93) g; and the hemorrhagic volume per unit area was (0.091 +/- 0.125) g/cm(2). In the control group, the corresponding values were (38.1 +/- 19.7) seconds, (4.00 +/- 4.75) g, and (0.095 +/- 0.101) g/cm(2), respectively. No significant difference in values existed between the two groups (P > 0.05). Blood coagulation results and hepatic and renal function were also similar between the two groups. Adverse events were reported in two cases, but were deemed non-drug-related.
  
  
  CONCLUSIONS
  Hemocoagulase Agkistrodon has good hemostatic and coagulative function and is safe for the use of arresting capillary hemorrhage that occurs while incising the abdomen during surgery.
authors.affiliation: Department of General Surgery, Beijing Hospital, Beijing 100730, China. weijunmin@263.net
authors.forename: Jun-min
authors.initials: JM
authors.lastname: Wei
authors.forename: Ming-wei
authors.initials: MW
authors.lastname: Zhu
authors.forename: Zhong-tao
authors.initials: ZT
authors.lastname: Zhang
authors.forename: Zhen-geng
authors.initials: ZG
authors.lastname: Jia
authors.forename: Xiao-dong
authors.initials: XD
authors.lastname: He
authors.forename: Yuan-lian
authors.initials: YL
authors.lastname: Wan
authors.forename: Shan
authors.initials: S
authors.lastname: Wang
authors.forename: Dian-rong
authors.initials: DR
authors.lastname: Xiu
authors.forename: Yun
authors.initials: Y
authors.lastname: Tang
authors.forename: Jie
authors.initials: J
authors.lastname: Li
authors.forename: Jing-yong
authors.initials: JY
authors.lastname: Xu
authors.forename: Qing-shan
authors.initials: QS
authors.lastname: Heng
mesh_terms: D000005:Abdomen / Q000601:surgery*; D000293:Adolescent; D000328:Adult; D000368:Aged; D017836:Agkistrodon; D000818:Animals; D012103:Batroxobin / Q000009:adverse effects / Q000494:pharmacology*; D001777:Blood Coagulation / Q000187:drug effects*; D004311:Double-Blind Method; D019317:Evidence-Based Medicine; D005260:Female; D006487:Hemostasis / Q000187:drug effects*; D006490:Hemostatics / Q000494:pharmacology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies
chemical_list: D006490:Hemostatics; D012103:Batroxobin