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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

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.


Condition or disease Intervention/treatment Phase
Idiopathic Scoliosis Drug: tranexamic acid and sodium chloride injection Drug: normal saline Drug: desmopressin acetate injection Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : December 2013
Estimated Primary Completion Date : April 2014
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

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

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.

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: desmopressin acetate injection
0.3μg/kg dissolved in 100ml NS,IV for 30min,before incision.
Other Name: DDAVP




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. postoperative complications [ Time Frame: up to 24 weeks after the surgery ]


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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02084342


Sponsors and Collaborators
Liu Weifeng
Investigators
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Study Chair: Wenqi Huang, Ph.D, M.D. First Affiliated Hospital, Sun Yat-Sen University

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Responsible Party: Liu Weifeng, attending doctor, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT02084342    
Other Study ID Numbers: TDS-SYSU-2013
First Posted: March 11, 2014    Key Record Dates
Last Update Posted: March 11, 2014
Last Verified: March 2014
Keywords provided by Liu Weifeng, First Affiliated Hospital, Sun Yat-Sen University:
desmopressin
tranexamic acid
blood loss
transfusion need
posterior scoliosis orthopedics
Additional relevant MeSH terms:
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Scoliosis
Hemorrhage
Pathologic Processes
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Deamino Arginine Vasopressin
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs