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

Not Applicable

• Conditions: Idiopathic Scoliosis
• Interventions: Drug: tranexamic acid and sodium chloride injection; Drug: desmopressin acetate injection; Drug: normal saline

• Registration Number: NCT02084342
• Lead Sponsor: Liu Weifeng

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.

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-15
• Status Verified: 2014-03
• Study First Submitted QC: 2014-03-10
• Last Update Submitted: 2014-03-10
• Study First Posted: 2014-03-11
• Last Update Posted: 2014-03-11
• Primary Completion: 2014-04
• Study Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group TD	desmopressin acetate injection	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.
Group TN	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. Normal saline (NS) 100ml IV for 20min, before incision.
Group TD	tranexamic acid and sodium chloride injection	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.
Group TN	tranexamic acid and sodium chloride injection	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.