An interventional study of tranexamic acid and sodium chloride injection and normal saline in Idiopathic Scoliosis, sponsored by Liu Weifeng. Status unknown. Open to participants aged 8 Years to 18 Years. Per ClinicalTrials.gov, last updated 2014-03-11.
Sponsored by Liu Weifeng · Not applicable, Interventional, and Treatment
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.
594 studies on the registry are indexed under Scoliosis; 139 are open to participants now.
This study's planned enrollment of 60 is above the median of 44 across 344 interventional studies indexed under Scoliosis.
Browse Scoliosis studies →Liu Weifeng is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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 · Drug: normal saline
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 · Drug: desmopressin acetate injection
10mg/kg, IV (in the vein) for 30min, before incision. then at 1mg/kg/h, IV pump, until the surgery is over.
Also known as: TXA
100ml, IV for 30min,before incision.
Also known as: NS
0.3μg/kg dissolved in 100ml NS，IV for 30min，before incision.
Also known as: DDAVP
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
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
postoperative complications
Time frame: up to 24 weeks after the surgery
No study locations are listed for this record.
This study is status unknown, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.
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Liu Weifeng