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Study of DDAVP Combined With TXA on the Blood Loss and Transfusion Need During and After Scoliosis Correction Surgery

Primary Purpose

Idiopathic Scoliosis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
tranexamic acid and sodium chloride injection
normal saline
desmopressin acetate injection
Sponsored by
Liu Weifeng
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Scoliosis focused on measuring desmopressin, tranexamic acid, blood loss, transfusion need, posterior scoliosis orthopedics

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • idiopathic scoliosis patients undergoing posterior scoliosis correction surgery
  • American society of anesthesiologists(ASA) classification:Ⅰ-Ⅱ
  • patients who agreed to participate in this study and has signed the informed consent

Exclusion Criteria:

  • blood disease，such as anaemia, idiopathic thrombocytopenic purpura(ITP)
  • history of bleeding or ecchymosis
  • disorders of laboratory examination on platelets(PLT),prothrombin time(PT),activated partial thromboplastin Time(aPTT),Fibrinogen,D-dimers
  • hypertension
  • cardiac disease,such as unstable angina, myocardial infarction in recent sis months, cardiac disfunction, congenital heart disease, pulmonary heart disease
  • cerebral ischemia
  • administering with anticoagulants or nonsteroidal anti-inflammatory drug(NSAID)
  • hepatic or renal disease or disfunction
  • blood transfusion in recent one month

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Group TN

    Group TD

    Arm Description

    Tranexamic acid and sodium chloride injection at 10mg/kg, IV (in the vein) for 30min, before incision.Then at 1mg/kg/h, IV pump, until the surgery is over. Normal saline (NS) 100ml IV for 20min, before incision.

    Tranexamic acid and sodium chloride injection at 10mg/kg, IV (in the vein) for 30min,before incision.Then at 1mg/kg/h,IV pump,until the surgery is over. Desmopressin acetate injection at 0.3μg/kg dissolved in 100ml NS, IV for 20min, before incision.

    Outcomes

    Primary Outcome Measures

    blood loss
    The blood loss include the volume of blood in suction bottles, the weight of sponges and seroma volume of drainage 3 days after surgery. All fluids added to the surgical field intraoperatively were carefully quantified and deducted from the measured blood loss.

    Secondary Outcome Measures

    blood transfusion
    The blood transfusion includes all the product needed during and in 3 days after the surgery.

    Full Information

    First Posted
    December 15, 2013
    Last Updated
    March 10, 2014
    Sponsor
    Liu Weifeng
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02084342
    Brief Title
    Study of DDAVP Combined With TXA on the Blood Loss and Transfusion Need During and After Scoliosis Correction Surgery
    Official Title
    Efficacy and Safety of Desmopressin Combined With Tranexamic Acid on the Blood Loss and Transfusion Need During and After Scoliosis Correction Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2014
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2013 (undefined)
    Primary Completion Date
    April 2014 (Anticipated)
    Study Completion Date
    June 2014 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Liu Weifeng

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Intraoperative administration of tranexamic acid (TXA,T) reduces significantly blood loss and blood transfusion requirements during spinal posterior fusion in adolescents with scoliosis. TXA acts mainly by inhibit the plasminogen activator. Desmopressin (DDAVP ,D) can inhibit the fibrinolytic activity by inducing the release of von Willebrand factor from the endothelial cells. But at the same time, it releases tissue-type plasminogen activator (t-PA), which may cripple its hemostatic effect. The investigators supposed that if the investigators combine TXA with DDAVP in scoliosis correction surgery, the blood loss and the transfusion need would be reduced significantly.
    Detailed Description
    Intraoperative administration of tranexamic acid (TXA,T) reduces significantly blood loss and blood transfusion requirements during spinal posterior fusion in adolescents with scoliosis. TXA acts mainly by inhibit the plasminogen activator. Desmopressin (DDAVP ,D) can inhibit the fibrinolytic activity by inducing the release of von Willebrand factor from the endothelial cells. But at the same time, it releases tissue-type plasminogen activator (t-PA), which may cripple its hemostatic effect. The investigators designed a a randomized double-blind clinical combining TXA with DDAVP in scoliosis correction surgery to observe if the blood loss and the transfusion need would be reduced or not.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Idiopathic Scoliosis
    Keywords
    desmopressin, tranexamic acid, blood loss, transfusion need, posterior scoliosis orthopedics

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Group TN
    Arm Type
    Placebo Comparator
    Arm Description
    Tranexamic acid and sodium chloride injection at 10mg/kg, IV (in the vein) for 30min, before incision.Then at 1mg/kg/h, IV pump, until the surgery is over. Normal saline (NS) 100ml IV for 20min, before incision.
    Arm Title
    Group TD
    Arm Type
    Experimental
    Arm Description
    Tranexamic acid and sodium chloride injection at 10mg/kg, IV (in the vein) for 30min,before incision.Then at 1mg/kg/h,IV pump,until the surgery is over. Desmopressin acetate injection at 0.3μg/kg dissolved in 100ml NS, IV for 20min, before incision.
    Intervention Type
    Drug
    Intervention Name(s)
    tranexamic acid and sodium chloride injection
    Other Intervention Name(s)
    TXA
    Intervention Description
    10mg/kg, IV (in the vein) for 30min, before incision. then at 1mg/kg/h, IV pump, until the surgery is over.
    Intervention Type
    Drug
    Intervention Name(s)
    normal saline
    Other Intervention Name(s)
    NS
    Intervention Description
    100ml, IV for 30min,before incision.
    Intervention Type
    Drug
    Intervention Name(s)
    desmopressin acetate injection
    Other Intervention Name(s)
    DDAVP
    Intervention Description
    0.3μg/kg dissolved in 100ml NS，IV for 30min，before incision.
    Primary Outcome Measure Information:
    Title
    blood loss
    Description
    The blood loss include the volume of blood in suction bottles, the weight of sponges and seroma volume of drainage 3 days after surgery. All fluids added to the surgical field intraoperatively were carefully quantified and deducted from the measured blood loss.
    Time Frame
    during and 3 days after the surgery
    Secondary Outcome Measure Information:
    Title
    blood transfusion
    Description
    The blood transfusion includes all the product needed during and in 3 days after the surgery.
    Time Frame
    during and 3 days after the surgery
    Other Pre-specified Outcome Measures:
    Title
    postoperative complications
    Time Frame
    up to 24 weeks after the surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    8 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: idiopathic scoliosis patients undergoing posterior scoliosis correction surgery American society of anesthesiologists(ASA) classification:Ⅰ-Ⅱ patients who agreed to participate in this study and has signed the informed consent Exclusion Criteria: blood disease，such as anaemia, idiopathic thrombocytopenic purpura(ITP) history of bleeding or ecchymosis disorders of laboratory examination on platelets(PLT),prothrombin time(PT),activated partial thromboplastin Time(aPTT),Fibrinogen,D-dimers hypertension cardiac disease,such as unstable angina, myocardial infarction in recent sis months, cardiac disfunction, congenital heart disease, pulmonary heart disease cerebral ischemia administering with anticoagulants or nonsteroidal anti-inflammatory drug(NSAID) hepatic or renal disease or disfunction blood transfusion in recent one month
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Wenqi Huang, Ph.D, M.D.
    Organizational Affiliation
    First Affiliated Hospital, Sun Yat-Sen University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Study of DDAVP Combined With TXA on the Blood Loss and Transfusion Need During and After Scoliosis Correction Surgery

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