Clinical trial NCT02084342: Study of DDAVP Combined With TXA on the Blood Loss and Transfusion Need During and After Scoliosis Correction Surgery
Official title: Efficacy and Safety of Desmopressin Combined With Tranexamic Acid on the Blood Loss and Transfusion Need During and After Scoliosis Correction Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Idiopathic Scoliosis
Keywords: desmopressin
tranexamic acid
blood loss
transfusion need
posterior scoliosis orthopedics
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2014-03-11
Enrollment: 60
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: blood loss
timeFrame: during and 3 days after the surgery
Secondary outcomes:
measure: blood transfusion
timeFrame: during and 3 days after the surgery
Other outcomes:
measure: postoperative complications
timeFrame: up to 24 weeks after the surgery
Locations:
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Wenqi Huang, Ph.D, M.D.
role: STUDY_CHAIR
References: