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

Liu Weifeng

Status: Unknown

Conditions: Idiopathic Scoliosis

Treatments: Drug: tranexamic acid and sodium chloride injection; Drug: normal saline; Drug: desmopressin acetate injection

Study type: Interventional

Funder types: Other

Identifiers

NCT02084342

TDS-SYSU-2013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 8 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Group TN

Placebo Comparator group

Description:

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.

Treatment:

Drug: normal saline

Drug: tranexamic acid and sodium chloride injection

Group TD

Experimental group

Description:

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.

Treatment:

Drug: desmopressin acetate injection

Drug: tranexamic acid and sodium chloride injection