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A multicenter, phase III trial of hemocoagulase Agkistrodon: hemostasis, coagulation, and safety in patients undergoing abdominal surgery.
Chin Med J (Engl). 2010 Mar 05; 123(5):589-93.CM

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+Show Affiliations

Department of General Surgery, Beijing Hospital, Beijing 100730, China. weijunmin@263.netNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20367987

Citation

Wei, Jun-min, et al. "A Multicenter, Phase III Trial of Hemocoagulase Agkistrodon: Hemostasis, Coagulation, and Safety in Patients Undergoing Abdominal Surgery." Chinese Medical Journal, vol. 123, no. 5, 2010, pp. 589-93.
Wei JM, Zhu MW, Zhang ZT, et al. A multicenter, phase III trial of hemocoagulase Agkistrodon: hemostasis, coagulation, and safety in patients undergoing abdominal surgery. Chin Med J. 2010;123(5):589-93.
Wei, J. M., Zhu, M. W., Zhang, Z. T., Jia, Z. G., He, X. D., Wan, Y. L., Wang, S., Xiu, D. R., Tang, Y., Li, J., Xu, J. Y., & Heng, Q. S. (2010). A multicenter, phase III trial of hemocoagulase Agkistrodon: hemostasis, coagulation, and safety in patients undergoing abdominal surgery. Chinese Medical Journal, 123(5), 589-93.
Wei JM, et al. A Multicenter, Phase III Trial of Hemocoagulase Agkistrodon: Hemostasis, Coagulation, and Safety in Patients Undergoing Abdominal Surgery. Chin Med J. 2010 Mar 5;123(5):589-93. PubMed PMID: 20367987.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A multicenter, phase III trial of hemocoagulase Agkistrodon: hemostasis, coagulation, and safety in patients undergoing abdominal surgery. AU - Wei,Jun-min, AU - Zhu,Ming-wei, AU - Zhang,Zhong-tao, AU - Jia,Zhen-geng, AU - He,Xiao-dong, AU - Wan,Yuan-lian, AU - Wang,Shan, AU - Xiu,Dian-rong, AU - Tang,Yun, AU - Li,Jie, AU - Xu,Jing-yong, AU - Heng,Qing-shan, PY - 2010/4/7/entrez PY - 2010/4/7/pubmed PY - 2010/6/30/medline SP - 589 EP - 93 JF - Chinese medical journal JO - Chin. Med. J. VL - 123 IS - 5 N2 - 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. SN - 2542-5641 UR - https://www.unboundmedicine.com/medline/citation/20367987/A_multicenter_phase_III_trial_of_hemocoagulase_Agkistrodon:_hemostasis_coagulation_and_safety_in_patients_undergoing_abdominal_surgery_ L2 - http://Insights.ovid.com/pubmed?pmid=20367987 DB - PRIME DP - Unbound Medicine ER -