A multicenter, phase III trial of hemocoagulase Agkistrodon: hemostasis, coagulation, and safety in patients undergoing abdominal surgery.
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.
Wei
Jun-min
JM
Department of General Surgery, Beijing Hospital, Beijing 100730, China. weijunmin@263.net
Zhu
Ming-wei
MW
Zhang
Zhong-tao
ZT
Jia
Zhen-geng
ZG
He
Xiao-dong
XD
Wan
Yuan-lian
YL
Wang
Shan
S
Xiu
Dian-rong
DR
Tang
Yun
Y
Li
Jie
J
Xu
Jing-yong
JY
Heng
Qing-shan
QS
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
D006490:Hemostatics; D012103:Batroxobin