title: The impact of hemocoagulase for improvement of coagulation and reduction of bleeding in fracture-related hip hemiarthroplasty geriatric patients: A prospective, single-blinded, randomized, controlled study.
abstract: BACKGROUND
  Uncontrolled bleeding is associated with poor outcomes and mortality in geriatric patients undergoing hemiarthroplasty. Hemocoagulase agkistrodon is a hemocoagulative, anti-hemorrhagic enzyme complex from Deinagkistrodon acutus snake venom. This study aimed to investigate the efficacy of hemocoagulase agkistrodon on coagulation and bleeding outcomes in fracture-related hemiarthroplasty.
  
  
  METHODS
  This was a prospective, single-blinded, randomized controlled trial carried out between October 2013 and September 2014 in 96 geriatric patients undergoing hemiarthroplasty for unilateral femoral neck fracture. Patients were administrated hemocoagulase agkistrodon (n=48) or normal saline (n=48). Intraoperative blood loss, transfusion volume and rate, and drainage were assessed. Hemoglobin (Hb) and coagulation parameters (prothrombin time [PT], thrombin time [TT], plasma fibrinogen [FIB], and activated partial thromboplastin time [aPTT]) were recorded preoperatively and 30min and 1, 3, and 5days after surgery. Complications were followed up for 4 weeks.
  
  
  RESULTS
  Compared to controls, hemocoagulase patients exhibited lower intraoperative blood loss (P<0.01) and postoperative blood loss, total drainage, mean transfusion volume, and transfusion rates (all P<0.05), with lower aPTT at 30min (P<0.05). No significant differences in postoperative FIB were observed. Controls exhibited significantly higher PP and TT on day 1, and Hb on days 1, 3, and 5 (P<0.05). No serious complications were reported.
  
  
  CONCLUSIONS
  Hemocoagulase reduced blood loss and transfusion in fracture-related hip hemiarthroplasty without increasing short-term adverse event rates. In geriatric populations, hemocoagulase could be used for limiting bleeding and related complications.
  
  
  BACKGROUND
  This trial is registered in the Chinese Clinical Trial Register (no. ChiCTR-TRC-14004379).
authors.affiliation: Department of Surgery, Fujian Provincial Hospital Emergency Center; Provincial Clinical College of Fujian Medical University; Fujian Provincial Emergency Medicine Institute, Fuzhou, China.
authors.forename: Meiguang
authors.initials: M
authors.lastname: Qiu
authors.affiliation: Department of Surgery, Fujian Provincial Hospital Emergency Center; Provincial Clinical College of Fujian Medical University; Fujian Provincial Emergency Medicine Institute, Fuzhou, China. Electronic address: zhanjunshisci@163.com.
authors.forename: Xuming
authors.initials: X
authors.lastname: Zhang
authors.affiliation: Department of Surgery, Fujian Provincial Hospital Emergency Center; Provincial Clinical College of Fujian Medical University; Fujian Provincial Emergency Medicine Institute, Fuzhou, China.
authors.forename: Hongru
authors.initials: H
authors.lastname: Cai
authors.affiliation: Department of Surgery, Fujian Provincial Hospital Emergency Center; Provincial Clinical College of Fujian Medical University; Fujian Provincial Emergency Medicine Institute, Fuzhou, China.
authors.forename: Zhixian
authors.initials: Z
authors.lastname: Xu
authors.affiliation: Department of Surgery, Fujian Provincial Hospital Emergency Center; Provincial Clinical College of Fujian Medical University; Fujian Provincial Emergency Medicine Institute, Fuzhou, China.
authors.forename: Hao
authors.initials: H
authors.lastname: Lin
mesh_terms: D061605:Administration, Intravenous; D000368:Aged; D000369:Aged, 80 and over; D012103:Batroxobin / Q000008:administration & dosage* / Q000494:pharmacology; D001777:Blood Coagulation / Q000187:drug effects; D001780:Blood Coagulation Tests; D016063:Blood Loss, Surgical / Q000517:prevention & control*; D001803:Blood Transfusion / Q000706:statistics & numerical data*; D002681:China / Q000453:epidemiology; D005260:Female; D005265:Femoral Neck Fractures / Q000150:complications* / Q000401:mortality / Q000601:surgery; D006299:Health Services for the Aged; D062785:Hemiarthroplasty / Q000009:adverse effects / Q000379:methods* / Q000401:mortality; D006490:Hemostatics / Q000008:administration & dosage* / Q000494:pharmacology; D006801:Humans; D008297:Male; D011446:Prospective Studies; D016896:Treatment Outcome
chemical_list: D006490:Hemostatics; D012103:Batroxobin
keywords: Bleeding; Blood loss; Coagulation; Femoral neck fracture; Geriatric populations; Hemiarthroplasty; Hemocoagulase