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

Injury. 2017 Apr;48(4):914-919. doi: 10.1016/j.injury.2016.11.028. Epub 2016 Nov 27.

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.

Patients and 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.

Trial registration: This trial is registered in the Chinese Clinical Trial Register (no. ChiCTR-TRC-14004379).

Keywords: Bleeding; Blood loss; Coagulation; Femoral neck fracture; Geriatric populations; Hemiarthroplasty; Hemocoagulase.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Administration, Intravenous
  • Aged
  • Aged, 80 and over
  • Batroxobin / administration & dosage*
  • Batroxobin / pharmacology
  • Blood Coagulation Tests
  • Blood Coagulation* / drug effects
  • Blood Loss, Surgical / prevention & control*
  • Blood Transfusion / statistics & numerical data*
  • China / epidemiology
  • Female
  • Femoral Neck Fractures / complications*
  • Femoral Neck Fractures / mortality
  • Femoral Neck Fractures / surgery
  • Health Services for the Aged
  • Hemiarthroplasty / adverse effects
  • Hemiarthroplasty / methods*
  • Hemiarthroplasty / mortality
  • Hemostatics / administration & dosage*
  • Hemostatics / pharmacology
  • Humans
  • Male
  • Prospective Studies
  • Treatment Outcome

Substances

  • Hemostatics
  • Batroxobin