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

NCT ID: NCT02084342

Last Updated: 2014-03-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2014-06-30

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.

Conditions

Idiopathic Scoliosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Group TN

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.

Group Type: PLACEBO_COMPARATOR

tranexamic acid and sodium chloride injection

Intervention Type: DRUG

10mg/kg, IV (in the vein) for 30min, before incision. then at 1mg/kg/h, IV pump, until the surgery is over.

normal saline

Intervention Type: DRUG

100ml, IV for 30min,before incision.

Group TD

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.

Group Type: EXPERIMENTAL

tranexamic acid and sodium chloride injection

Intervention Type: DRUG

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

Intervention Type: DRUG

0.3μg/kg dissolved in 100ml NS，IV for 30min，before incision.

Interventions

tranexamic acid and sodium chloride injection

10mg/kg, IV (in the vein) for 30min, before incision. then at 1mg/kg/h, IV pump, until the surgery is over.

Intervention Type: DRUG

normal saline

100ml, IV for 30min,before incision.

Intervention Type: DRUG

desmopressin acetate injection

0.3μg/kg dissolved in 100ml NS，IV for 30min，before incision.

Intervention Type: DRUG

Other Intervention Names

TXA; NS; DDAVP

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Liu Weifeng

OTHER

Sponsor Role: lead

Responsible Party

Liu Weifeng

attending doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Wenqi Huang, Ph.D, M.D.

Role: STUDY_CHAIR

First Affiliated Hospital, Sun Yat-Sen University

Other Identifiers

TDS-SYSU-2013

Identifier Type: -

Identifier Source: org_study_id