Tranexamic Acid in Paediatric Scoliosis Surgery (TRIPSS)

• Register: ANZCTR
• Last refreshed on: 4 July 2017
• Main ID: ACTRN12617000663358
• Date of registration: 08/05/2017
• Prospective Registration: Yes
• Primary sponsor: Associate Professor Dr. Mohd Shahnaz Hasan
• Public title: Tranexamic Acid in Paediatric Scoliosis Surgery (TRIPSS)
• Scientific title: Randomised Trial of Low Dose versus High Dose Tranexamic Acid in Paediatric Scoliosis Surgery-effect on intraoperative blood loss and transfusion requirement
• Date of first enrolment: 1/06/2017
• Target sample size: 160
• Recruitment status: Recruiting
• URL: http://www.anzctr.org.au/ACTRN12617000663358.aspx
• Study type: Interventional
• Study design: Randomised controlled trial Parallel
• Phase: Phase 2 / Phase 3

Health Condition(s) or Problem(s) studied

Adolescent idiopathic scoliosis

Intervention(s)

This study aims at determine the efficacy of Tranexamic Acid in adolescent idiopathic scoliosis surgery. A total of 160 patients are assigned into 2 groups (80 patients each)- high dose (30mg/kg loading dose over 15 minutes 30 to 60 minutes prior to surgical incision, follow by 10mg/kg/hour ) or low dose (10mg/kg loading dose over 15 minutes at 30-60minutes prior to surgical incision; follow by 1mg/kg/hour) Tranexamic Acid Regime.

Tranexamic Acid 500mg/5ml injection Bioindustria laboratorio Italiano Medinali (L.I.M) will be adminstered to the patients.

Total intraoperative Blood loss will be calculated from the cell salvage system as well as weighing the soaked sponges. This collected cell salvage blood will be re-infused to patient at the completion of surgery. For all groups,Ringer’s lactate solution will be used throughout the operation as maintenance fluid therapy and as replacement for insensible fluid loss in accordance with Holliday-Segar formula.

Should the patient developed hypotension with MAP < 60mmHg or tachycardia >20% from baseline intraoperatively, additional 5mls/kg bolus of Ringer’s lactate solution will be given to patient and can be repeated up to 4 times if necessary. However, if persistent hemodynamic instability and there is more than 20% loss of blood volume, collected cell salvage blood will be transfused back to patient immediately.

Allogenic blood would be administered when the intraoperative Hemoglobin concentration fell below 8gdl-1 despite completion of autologous blood and adequate fluid resuscitation with persistent hemodynamic instability i.e. persistent hypotension or tachycardia >20% from baseline.

Patients with postoperative Hemoglobin value of less than 8gdl-1 will also receive one unit of allogenic packed red cell transfusion.

All patients will be followed up until hospital discharge and within 30 days post-operation period.