title: The beneficial effect of Batroxobin on blood loss reduction in spinal fusion surgery: a prospective, randomized, double-blind, placebo-controlled study.
abstract: OBJECTIVE
  Our objective was to evaluate the efficacy and safety of Batroxobin on blood loss during spinal operations.
  
  
  METHODS
  After obtaining approval from the ethics committee at the hospital along with informed written consent, we performed a double-blind, randomized, placebo-controlled study with 100 patients who were randomized equally into 2 groups (Batroxobin and placebo). Patients received either 2 ku IV 15 min before surgery and followed 1 ku IM of Batroxobin following surgery, or an equivalent volume of placebo (normal saline). Cost of Batroxobin treatment is amounted to 84.75 euros. The primary outcomes were intraoperative, 24 h postoperative, and total perioperative blood loss. Secondary outcomes were hemoglobin (Hb), red blood cell count (RBC), the volume of blood/fluid transfusion intraoperatively, and 24 h postoperatively. Safety evaluation parameters were the incidence of venous thrombosis in the lower extremities, active partial thromboplastin time, prothrombin time, thrombin time, and fibrinogen. The data were analyzed using the Statistical Package for the Social Science Version 12.0. The results were presented as mean ± SEM. The Mann-Whitney test and Independent Student t test, when appropriate, were used to compare the 2 groups, and differences were considered significant if the P value was <0.05.
  
  
  RESULTS
  88 patients were included in the analysis while 12 patients were withdrawn from the study due to extended surgical duration, change of surgical procedure, or after the patients' request. The total perioperative blood loss was approximately 31% lower in patients given Batroxobin versus placebo (700.5 ± 45.81 vs 485.7 ± 30.01 mL, P = 0.001). The Batroxobin group had significantly less intraoperative blood loss (326.1 ± 24.16) compared to the placebo group (556.0 ± 43.58), but there was no difference in the amount of blood/fluid transfused, postoperatively Hb, or RBC between the two groups. After the operation, coagulation parameters were not significantly different between the 2 groups at the days 1 or 3 postoperatively. No adverse events related to the use of Batroxobin were recorded. There were no cases of superficial wound infection. None of the subjects died during the study.
  
  
  CONCLUSIONS
  In this study, prophylactic use of Batroxobin provided an effective and cheap method for reducing blood loss without coagulopathy during or after operations. The use of Batroxobin for patients undergoing one-level PLIF surgery safely and effectively reduced the total amount of perioperative blood loss.
authors.affiliation: Department of Spine Surgery, Honghui Hospital, Xi'an Jiaotong University College of Medicine, No. 76 Nanguo Road, Xi'an, 710054, Shaanxi, People's Republic of China, 315593193@qq.com.
authors.forename: Hui-Min
authors.initials: HM
authors.lastname: Hu
authors.forename: Li
authors.initials: L
authors.lastname: Chen
authors.forename: Charles Edward
authors.initials: CE
authors.lastname: Frary
authors.forename: Chi-Chih
authors.initials: CC
authors.lastname: Chang
authors.forename: Hua
authors.initials: H
authors.lastname: Hui
authors.forename: Hai-Ping
authors.initials: HP
authors.lastname: Zhang
authors.forename: Da-Geng
authors.initials: DG
authors.lastname: Huang
authors.forename: Zhong-Kai
authors.initials: ZK
authors.lastname: Liu
authors.forename: Yuan-Ting
authors.initials: YT
authors.lastname: Zhao
authors.forename: Si-Min
authors.initials: SM
authors.lastname: He
authors.forename: Xue-Fang
authors.initials: XF
authors.lastname: Zhang
authors.forename: Bao-Rong
authors.initials: BR
authors.lastname: He
authors.forename: Ding-Jun
authors.initials: DJ
authors.lastname: Hao
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D012103:Batroxobin / Q000008:administration & dosage*; D016063:Blood Loss, Surgical / Q000517:prevention & control*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006490:Hemostatics / Q000008:administration & dosage; D006801:Humans; D007275:Injections, Intravenous; D008297:Male; D008875:Middle Aged; D011184:Postoperative Period; D011446:Prospective Studies; D013123:Spinal Fusion; D055815:Young Adult
chemical_list: D006490:Hemostatics; D012103:Batroxobin