Overview

This trial is active, not recruiting.

Condition idiopathic scoliosis
Treatments tranexamic acid and sodium chloride injection, normal saline, desmopressin acetate injection
Sponsor Liu Weifeng
Start date December 2013
End date April 2014
Trial size 60 participants
Trial identifier NCT02084342, TDS-SYSU-2013

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
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.
tranexamic acid and sodium chloride injection TXA
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 30min,before incision.
(Experimental)
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.
tranexamic acid and sodium chloride injection TXA
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 DDAVP
0.3μg/kg dissolved in 100ml NS,IV for 30min,before incision.

Primary Outcomes

Measure
blood loss
time frame: during and 3 days after the surgery

Secondary Outcomes

Measure
blood transfusion
time frame: during and 3 days after the surgery

Eligibility Criteria

Male or female participants from 8 years up to 18 years old.

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

Additional Information

Official title Efficacy and Safety of Desmopressin Combined With Tranexamic Acid on the Blood Loss and Transfusion Need During and After Scoliosis Correction Surgery
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2014.
Information provided to ClinicalTrials.gov by First Affiliated Hospital, Sun Yat-Sen University.