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

N/AUnknownNCT02084342

Liu Weifeng60 enrolled

Overview

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.

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Idiopathic Scoliosis

Interventions

tranexamic acid and sodium chloride injectionDRUG

10mg/kg, IV (in the vein) for 30min, before incision. then at 1mg/kg/h, IV pump, until the surgery is over.

normal salineDRUG

100ml, IV for 30min,before incision.

desmopressin acetate injectionDRUG

0.3μg/kg dissolved in 100ml NS，IV for 30min，before incision.

Eligibility

Sex: ALLMin age: 8 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: during and 3 days after the surgery

Secondary Outcomes

blood transfusion

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