Study of DDAVP Combined With TXA on the Blood Loss and Transfusion Need During and After Scoliosis Correction Surgery
Information source: First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Idiopathic Scoliosis
Intervention: tranexamic acid and sodium chloride injection (Drug); normal saline (Drug); desmopressin acetate injection (Drug)
Phase: N/A
Status: Active, not recruiting
Sponsored by: Liu Weifeng Official(s) and/or principal investigator(s): Wenqi Huang, Ph.D, M.D., Study Chair, Affiliation: First Affiliated Hospital, Sun Yat-Sen University
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: blood loss
Secondary outcome: blood transfusion
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
Minimum age: 8 Years.
Maximum age: 18 Years.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: December 2013
Last updated: March 10, 2014
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