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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy and Safety of Desmopressin Combined With Tranexamic Acid on the Blood Loss and Transfusion Need During and After Scoliosis Correction Surgery

Conditions
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Idiopathic Scoliosis

Intervention / Treatment
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* Drug: tranexamic acid and sodium chloride injection
* Drug: normal saline
* Drug: desmopressin acetate injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group TN<br>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<br>* 10mg/kg, IV (in the vein) for 30min, before incision. then at 1mg/kg/h, IV pump, until the surgery is over.<br>* Other names: TXA;Drug: normal saline<br>* 100ml, IV for 30min,before incision.<br>* Other names: NS;|
| Experimental: Group TD<br>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<br>* 10mg/kg, IV (in the vein) for 30min, before incision. then at 1mg/kg/h, IV pump, until the surgery is over.<br>* Other names: TXA;Drug: desmopressin acetate injection<br>* 0.3μg/kg dissolved in 100ml NS，IV for 30min，before incision.<br>* Other names: DDAVP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | during and 3 days after the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood transfusion | The blood transfusion includes all the product needed during and in 3 days after the surgery. | during and 3 days after the surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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desmopressin, tranexamic acid, blood loss, transfusion need, posterior scoliosis orthopedics