Idiopathic Scoliosis
Conditions
Keywords
desmopressin, tranexamic acid, blood loss, transfusion need, posterior scoliosis orthopedics
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.
Interventions
DRUGtranexamic 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.
DRUGnormal saline
100ml, IV for 30min,before incision.
DRUGdesmopressin acetate injection
0.3μg/kg dissolved in 100ml NS，IV for 30min，before incision.
Sponsors
Liu Weifeng
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| blood loss | 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
| Measure | Time frame | Description |
|---|---|---|
| blood transfusion | during and 3 days after the surgery | The blood transfusion includes all the product needed during and in 3 days after the surgery. |
Other
| Measure | Time frame |
|---|---|
| postoperative complications | up to 24 weeks after the surgery |
Outcome results
None listed