Clinical Trial: Tranexamic Acid in Reducing Gross Hemorrhage and Transfusions of Spine Surgeries

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Intravenous Versus Topical Use of Tranexamic Acid in Reducing Gross Hemorrhage and Transfusions of Spine Surgeries (TARGETS) : A Prospective, Randomized, Double Blind, Head-to-head Comparison Study

Brief Summary: Multilevel decompression and bone graft fusion is a most effective measure for treating degenerative lumbar spinal diseases. Yet, the surgery is commonly associated with large amount of perioperative blood loss and high demand for homologous blood transfusion. Tranexamic acid (TXA) has been proved as efficient in reducing the gross blood loss in various kinds of surgeries. However, high quality evidence of its efficacy and safety is still lacking in lumbar spinal surgeries. Besides, systemic use of TXA carries the risks of thromboembolic complications such as deep venous thrombosis and pulmonary embolism, thus the optimal drug delivery route of TXA remains undetermined. The aim of this study is to test the non-inferiority of topical TXA application to its intravenous use in multilevel decompression and bone graft fusion surgeries. A prospective, randomized, double-blind, head-to-head comparison study design will be adopted.

Detailed Summary:
Sponsor: Peking Union Medical College Hospital

Current Primary Outcome: Perioperative Total blood loss (TBL) [ Time Frame: Since operation initiation till postoperative day 3 (POD3) ]

TBL= PBV*（hematocrit on postoperative day 3- preoperative hematocrit）/average hematocrit; Predicted blood volume(PBV)= k1* height^3(m)+ k2* weight(kg)+ k3 (female: k1=0.3561， k2=0.03308， k3=0.1833, male: k1=0.3669， k2=0.03219， k3=0.6041)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Visible intraoperative blood loss [ Time Frame: Since operation initiation till operation completion, an average of 120min ]
  • Visible postoperative blood loss within 24hrs [ Time Frame: 0- 24hrs postoperatively ]
  • Visible postoperative blood loss within 48hrs [ Time Frame: 0- 48hrs postoperatively ]
  • Combined visible perioperative blood loss [ Time Frame: Since operation initiation till postoperative 48hrs ]
    Combined visible perioperative blood loss= visible intraoperative blood loss + visible postoperative blood loss within 24hrs + visible postoperative blood loss within 48hrs
  • Total postoperative blood loss [ Time Frame: 0- 48hrs postoperatively ]
    Total postoperative blood loss= drainage day1(ml)* drainage Hct day1(%)/blood Hct day1(%)+ drainage day2(ml)* drainage Hct day2(%)/blood Hct day2(%)
  • Postoperative hidden blood loss (HBL) [ Time Frame: 48hrs postoperatively ]
    HBL=TBL- combined visible perioperative blood loss
  • Postoperative prothrombin time(PT) [ Time Frame: Tested at operation completion, postoperative 24hrs and postoperative 48hrs ]
  • Postoperative activated partial thromboplastin time(APTT) [ Time Frame: Tested at operation completion, postoperative 24hrs and postoperative 48hrs ]
  • Postoperative fibrinogen level(Fbg) [ Time Frame: Tested at operation completion, postoperative 24hrs and postoperative 48hrs ]
  • Postoperative international normalized ratio(INR) [ Time Frame: Tested at operation completion, postoperative 24hrs and postoperative 48hrs ]
  • Postoperative R time [ Time Frame: Tested at operation completion, postoperative 24hrs and postoperative 48hrs, using thromboelastography tests. ]
  • Postoperative K time [ Time Frame: Tested at operation completion, postoperative 24hrs and postoperative 48hrs, using thromboelastography tests. ]
  • Postoperative maximum amplitude (MA) [ Time Frame: Tested at operation completion, postoperative 24hrs and postoperative 48hrs, using thromboelastography tests. ]
  • Postoperative lysis after 30 minutes(LY 30) [ Time Frame: Tested at operation completion, postoperative 24hrs and postoperative 48hrs, using thromboelastography tests. ]
  • Postoperative hemoglobin nadir [ Time Frame: Since operation completion till postoperative 48hrs ]
  • Perioperative transfusion rates [ Time Frame: Since operation initiation till postoperative 48hrs ]
  • Perioperative transfusion amounts [ Time Frame: Since operation initiation till postoperative 48hrs ]
  • Length of hospital stay [ Time Frame: A single inpatient duration since the day of admission till the day of discharge, an average of 1 week ]
    Length of hospital stay is calculated by subtracting day of admission from day of discharge.
  • Adverse event rates [ Time Frame: Since operation initiation till postoperative 48hrs ]
    Adverse events include deep venous thrombosis, myocardial infarction, pulmonary embolism, cerebrovascular disease, impaired liver function, impaired renal function and incisional hematoma/ infection.


Original Secondary Outcome: Same as current

Information By: Peking Union Medical College Hospital

Dates:
Date Received: December 16, 2016
Date Started: February 2017
Date Completion:
Last Updated: January 4, 2017
Last Verified: January 2017