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

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ClinicalTrials.gov Identifier: NCT02084342
Recruitment Status : Unknown
Verified March 2014 by Liu Weifeng, First Affiliated Hospital, Sun Yat-Sen University.
Recruitment status was:  Active, not recruiting
First Posted : March 11, 2014
Last Update Posted : March 11, 2014
Sponsor:
Information provided by (Responsible Party):
Liu Weifeng, First Affiliated Hospital, Sun Yat-Sen University

Tracking Information
First Submitted Date  ICMJE December 15, 2013
First Posted Date  ICMJE March 11, 2014
Last Update Posted Date March 11, 2014
Study Start Date  ICMJE December 2013
Estimated Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 10, 2014)
blood loss [ Time Frame: during and 3 days after the surgery ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 10, 2014)
blood transfusion [ Time Frame: during and 3 days after the surgery ]
The blood transfusion includes all the product needed during and in 3 days after the surgery.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 10, 2014)
postoperative complications [ Time Frame: up to 24 weeks after the surgery ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Study of DDAVP Combined With TXA on the Blood Loss and Transfusion Need During and After Scoliosis Correction Surgery
Official Title  ICMJE Efficacy and Safety of Desmopressin Combined With Tranexamic Acid on the Blood Loss and Transfusion Need During and After Scoliosis Correction Surgery
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Idiopathic Scoliosis
Intervention  ICMJE
  • Drug: tranexamic acid and sodium chloride injection
    10mg/kg, IV (in the vein) for 30min, before incision. then at 1mg/kg/h, IV pump, until the surgery is over.
    Other Name: TXA
  • Drug: normal saline
    100ml, IV for 30min,before incision.
    Other Name: NS
  • Drug: desmopressin acetate injection
    0.3μg/kg dissolved in 100ml NS,IV for 30min,before incision.
    Other Name: DDAVP
Study Arms  ICMJE
  • Placebo Comparator: Group TN

    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.

    Interventions:
    • Drug: tranexamic acid and sodium chloride injection
    • Drug: normal saline
  • Experimental: Group TD

    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.

    Interventions:
    • Drug: tranexamic acid and sodium chloride injection
    • Drug: desmopressin acetate injection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 10, 2014)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2014
Estimated Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02084342
Other Study ID Numbers  ICMJE TDS-SYSU-2013
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Liu Weifeng, First Affiliated Hospital, Sun Yat-Sen University
Study Sponsor  ICMJE Liu Weifeng
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Wenqi Huang, Ph.D, M.D. First Affiliated Hospital, Sun Yat-Sen University
PRS Account First Affiliated Hospital, Sun Yat-Sen University
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP