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

Efficacy and Safety of Desmopressin Combined With Tranexamic Acid on the Blood Loss and Transfusion Need During and After Scoliosis Correction Surgery

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.

Study Overview

• Status: Unknown
• Conditions: Idiopathic Scoliosis
• Intervention / Treatment: Drug: tranexamic acid and sodium chloride injection; Drug: normal saline; Drug: desmopressin acetate injection

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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.	Drug: 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.; Other Names: TXA; Drug: normal saline; 100ml, IV for 30min,before incision.; Other Names: NS
Experimental: 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.	Drug: 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.; Other Names: TXA; Drug: desmopressin acetate injection; 0.3μg/kg dissolved in 100ml NS，IV for 30min，before incision.; Other Names: DDAVP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood loss	The blood loss include the volume of blood in suction bottles, the weight of sponges and seroma volume of drainage 3 days after surgery. All fluids added to the surgical field intraoperatively were carefully quantified and deducted from the measured blood loss.	during and 3 days after the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood transfusion	The blood transfusion includes all the product needed during and in 3 days after the surgery.	during and 3 days after the surgery

Other Outcome Measures

Outcome Measure	Time Frame
postoperative complications	up to 24 weeks after the surgery

Collaborators and Investigators

• Sponsor: Liu Weifeng
• Investigators: Study Chair: Wenqi Huang, Ph.D, M.D., First Affiliated Hospital, Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Anticipated): April 1, 2014
• Study Completion (Anticipated): June 1, 2014

Study Registration Dates

• First Submitted: December 15, 2013
• First Submitted That Met QC Criteria: March 10, 2014
• First Posted (Estimate): March 11, 2014

Study Record Updates

• Last Update Posted (Estimate): March 11, 2014
• Last Update Submitted That Met QC Criteria: March 10, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: blood loss; tranexamic acid; desmopressin; transfusion need; posterior scoliosis orthopedics
• Additional Relevant MeSH Terms: Pathologic Processes; Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Hemorrhage; Scoliosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Natriuretic Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Antidiuretic Agents; Tranexamic Acid; Deamino Arginine Vasopressin
• Other Study ID Numbers: TDS-SYSU-2013