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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

Page last updated: August 23, 2015

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