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Tranexamic Acid in Reducing Gross Hemorrhage and Transfusions of Spine Surgeries (TARGETS)

Primary Purpose

Spinal Stenosis, Intervertebral Disc Displacement

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Wound topically irrigated with 500mg TXA
1mg/kg/hr TXA intravenous infusion till the last suture
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Stenosis

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • American Society of Anesthesiologists(ASA)classification of physical status I-II.
  • Aged over 50yrs.
  • Patients suffering from spinal stenosis or intervertebral disc displacement and require multilevel decompression and bone graft fusion surgeries.
  • Written informed consent.

Exclusion Criteria:

  • ASA III-IV.
  • Age≤ 50yrs.
  • History of chronic renal dysfunction (preoperative blood creatinine> 120mmol/L), liver dysfunction (preoperative blood aspartate or alanine aminotransferase> 50 units/L) or history of coronary artery disease with stent placement.
  • Abnormal preoperative coagulation profile (preoperative prothrombin time elongation> 3s, activated partial thromboplastin time elongation> 10s, platelet counts< 100*10^9/L or >400*10^9/L, or INR> 1.4).
  • Pre-existing anemia (male< 12g/dL, female<11g/dL).
  • Long-term medications of aspirin and/or other anticoagulants.
  • Patients known as allergic to TXA.
  • Patients who have religious and/or other beliefs limiting blood transfusion.
  • Dura mater laceration and/or unexpected massive bleeding during operation.
  • Cell saver application during operation.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Experimental

    Control

    Arm Description

    Loading dose: 100ml 0.9% normal saline(NS) intravenous infusion, 15-20min prior to operation initiation. Maintenance dose: 5ml/hr 0.9% NS intravenous infusion till the last suture. Bolus dose: the wound topically irrigated with 500mg TXA in 250ml 0.9% NS for 5min. Waste fluid was then removed by suction, and the wound was closed.

    Loading dose: 10mg/kg tranexamic acid(TXA) in 100ml 0.9% NS intravenous infusion, 15-20min prior to operation initiation. Maintenance dose: 1mg/kg/hr TXA intravenous infusion till the last suture. Bolus dose: the wound topically irrigated with 250ml 0.9% NS for 5min. Waste fluid was then removed by suction, and the wound was closed.

    Outcomes

    Primary Outcome Measures

    Perioperative Total blood loss (TBL)
    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)

    Secondary Outcome Measures

    Visible intraoperative blood loss
    Visible postoperative blood loss within 24hrs
    Visible postoperative blood loss within 48hrs
    Combined visible perioperative blood loss
    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
    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)
    HBL=TBL- combined visible perioperative blood loss
    Postoperative prothrombin time(PT)
    Postoperative activated partial thromboplastin time(APTT)
    Postoperative fibrinogen level(Fbg)
    Postoperative international normalized ratio(INR)
    Postoperative R time
    Postoperative K time
    Postoperative maximum amplitude (MA)
    Postoperative lysis after 30 minutes(LY 30)
    Postoperative hemoglobin nadir
    Perioperative transfusion rates
    Perioperative transfusion amounts
    Length of hospital stay
    Length of hospital stay is calculated by subtracting day of admission from day of discharge.
    Adverse event rates
    Adverse events include deep venous thrombosis, myocardial infarction, pulmonary embolism, cerebrovascular disease, impaired liver function, impaired renal function and incisional hematoma/ infection.

    Full Information

    First Posted
    December 16, 2016
    Last Updated
    January 4, 2017
    Sponsor
    Peking Union Medical College Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03011866
    Brief Title
    Tranexamic Acid in Reducing Gross Hemorrhage and Transfusions of Spine Surgeries
    Acronym
    TARGETS
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2017 (undefined)
    Primary Completion Date
    December 2018 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Peking Union Medical College Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Spinal Stenosis, Intervertebral Disc Displacement

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    176 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental
    Arm Type
    Experimental
    Arm Description
    Loading dose: 100ml 0.9% normal saline(NS) intravenous infusion, 15-20min prior to operation initiation. Maintenance dose: 5ml/hr 0.9% NS intravenous infusion till the last suture. Bolus dose: the wound topically irrigated with 500mg TXA in 250ml 0.9% NS for 5min. Waste fluid was then removed by suction, and the wound was closed.
    Arm Title
    Control
    Arm Type
    Other
    Arm Description
    Loading dose: 10mg/kg tranexamic acid(TXA) in 100ml 0.9% NS intravenous infusion, 15-20min prior to operation initiation. Maintenance dose: 1mg/kg/hr TXA intravenous infusion till the last suture. Bolus dose: the wound topically irrigated with 250ml 0.9% NS for 5min. Waste fluid was then removed by suction, and the wound was closed.
    Intervention Type
    Drug
    Intervention Name(s)
    Wound topically irrigated with 500mg TXA
    Intervention Type
    Drug
    Intervention Name(s)
    1mg/kg/hr TXA intravenous infusion till the last suture
    Primary Outcome Measure Information:
    Title
    Perioperative Total blood loss (TBL)
    Description
    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)
    Time Frame
    Since operation initiation till postoperative day 3 (POD3)
    Secondary Outcome Measure Information:
    Title
    Visible intraoperative blood loss
    Time Frame
    Since operation initiation till operation completion, an average of 120min
    Title
    Visible postoperative blood loss within 24hrs
    Time Frame
    0- 24hrs postoperatively
    Title
    Visible postoperative blood loss within 48hrs
    Time Frame
    0- 48hrs postoperatively
    Title
    Combined visible perioperative blood loss
    Description
    Combined visible perioperative blood loss= visible intraoperative blood loss + visible postoperative blood loss within 24hrs + visible postoperative blood loss within 48hrs
    Time Frame
    Since operation initiation till postoperative 48hrs
    Title
    Total postoperative blood loss
    Description
    Total postoperative blood loss= drainage day1(ml)* drainage Hct day1(%)/blood Hct day1(%)+ drainage day2(ml)* drainage Hct day2(%)/blood Hct day2(%)
    Time Frame
    0- 48hrs postoperatively
    Title
    Postoperative hidden blood loss (HBL)
    Description
    HBL=TBL- combined visible perioperative blood loss
    Time Frame
    48hrs postoperatively
    Title
    Postoperative prothrombin time(PT)
    Time Frame
    Tested at operation completion, postoperative 24hrs and postoperative 48hrs
    Title
    Postoperative activated partial thromboplastin time(APTT)
    Time Frame
    Tested at operation completion, postoperative 24hrs and postoperative 48hrs
    Title
    Postoperative fibrinogen level(Fbg)
    Time Frame
    Tested at operation completion, postoperative 24hrs and postoperative 48hrs
    Title
    Postoperative international normalized ratio(INR)
    Time Frame
    Tested at operation completion, postoperative 24hrs and postoperative 48hrs
    Title
    Postoperative R time
    Time Frame
    Tested at operation completion, postoperative 24hrs and postoperative 48hrs, using thromboelastography tests.
    Title
    Postoperative K time
    Time Frame
    Tested at operation completion, postoperative 24hrs and postoperative 48hrs, using thromboelastography tests.
    Title
    Postoperative maximum amplitude (MA)
    Time Frame
    Tested at operation completion, postoperative 24hrs and postoperative 48hrs, using thromboelastography tests.
    Title
    Postoperative lysis after 30 minutes(LY 30)
    Time Frame
    Tested at operation completion, postoperative 24hrs and postoperative 48hrs, using thromboelastography tests.
    Title
    Postoperative hemoglobin nadir
    Time Frame
    Since operation completion till postoperative 48hrs
    Title
    Perioperative transfusion rates
    Time Frame
    Since operation initiation till postoperative 48hrs
    Title
    Perioperative transfusion amounts
    Time Frame
    Since operation initiation till postoperative 48hrs
    Title
    Length of hospital stay
    Description
    Length of hospital stay is calculated by subtracting day of admission from day of discharge.
    Time Frame
    A single inpatient duration since the day of admission till the day of discharge, an average of 1 week
    Title
    Adverse event rates
    Description
    Adverse events include deep venous thrombosis, myocardial infarction, pulmonary embolism, cerebrovascular disease, impaired liver function, impaired renal function and incisional hematoma/ infection.
    Time Frame
    Since operation initiation till postoperative 48hrs

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: American Society of Anesthesiologists(ASA)classification of physical status I-II. Aged over 50yrs. Patients suffering from spinal stenosis or intervertebral disc displacement and require multilevel decompression and bone graft fusion surgeries. Written informed consent. Exclusion Criteria: ASA III-IV. Age≤ 50yrs. History of chronic renal dysfunction (preoperative blood creatinine> 120mmol/L), liver dysfunction (preoperative blood aspartate or alanine aminotransferase> 50 units/L) or history of coronary artery disease with stent placement. Abnormal preoperative coagulation profile (preoperative prothrombin time elongation> 3s, activated partial thromboplastin time elongation> 10s, platelet counts< 100*10^9/L or >400*10^9/L, or INR> 1.4). Pre-existing anemia (male< 12g/dL, female<11g/dL). Long-term medications of aspirin and/or other anticoagulants. Patients known as allergic to TXA. Patients who have religious and/or other beliefs limiting blood transfusion. Dura mater laceration and/or unexpected massive bleeding during operation. Cell saver application during operation.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Qianyu Zhuang, M.D.
    Phone
    86-13552869326
    Email
    zhuangqianyu@pumch.cn
    First Name & Middle Initial & Last Name or Official Title & Degree
    Qianyu Zhuang, M.D.
    Phone
    86-13552869326
    Email
    zhuangqianyu@126.com

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    30755256
    Citation
    Hui S, Tao L, Mahmood F, Xu D, Ren Z, Chen X, Sheng L, Zhuang Q, Li S, Huang Y. Tranexamic Acid in Reducing Gross Hemorrhage and Transfusions of Spine Surgeries (TARGETS): study protocol for a prospective, randomized, double-blind, non-inferiority trial. Trials. 2019 Feb 12;20(1):125. doi: 10.1186/s13063-019-3231-9.
    Results Reference
    derived

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    Tranexamic Acid in Reducing Gross Hemorrhage and Transfusions of Spine Surgeries

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