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

NCT02084342 | Unknown DMC

• 1 other identifier: TDS-SYSU-2013
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Idiopathic Scoliosis

Keywords

desmopressin; tranexamic acid; blood loss; transfusion need; posterior scoliosis orthopedics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• blood transfusion

  during and 3 days after the surgery

Other Outcomes (1)

• postoperative complications

  up to 24 weeks after the surgery

Study Arms (2)

Group TN

PLACEBO COMPARATOR

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; Drug: normal saline

Group TD

EXPERIMENTAL

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; Drug: desmopressin acetate injection

Interventions

tranexamic acid and sodium chloride injection DRUG

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

Also known as: TXA

Group TD; Group TN

normal saline DRUG

100ml, IV for 30min,before incision.

Also known as: NS

Group TN

desmopressin acetate injection DRUG

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

Also known as: DDAVP

Group TD

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Liu Weifeng: lead

MeSH Terms

Conditions

Hemorrhage

Interventions

Tranexamic Acid; Sodium Chloride; Saline Solution; Deamino Arginine Vasopressin

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Arginine Vasopressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Wenqi Huang, Ph.D, M.D.

  First Affiliated Hospital, Sun Yat-Sen University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: attending doctor

Study Record Dates

• First Submitted: December 15, 2013
• First Posted: March 11, 2014
• Study Start: December 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: June 1, 2014
• Last Updated: March 11, 2014

Record last verified: 2014-03