Non-Idiopathic Scoliosis Treated With Tranexamic Acid

NCT01089140 | Terminated Phase 2

• 1 other identifier: 1000013524
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

Investigation of tranexamic acid (TXA) for reducing perioperative blood loss and transfusion requirement in pediatric patients with secondary scoliosis undergoing posterior spinal fusion.

Conditions

Non-idiopathic Scoliosis

Keywords

pediatrics; scoliosis; tranexamic acid; Investigating non-idiopathic scoliosis

Outcome Measures

Primary Outcomes (1)

• Perioperative blood loss and transfusion requirement

  8 hours

Secondary Outcomes (2)

• Thromboelastography (TEG): TEG monitors coagulation of blood samples in vitro to produce a complete picture of clot formation, strength and dissolution (i.e. fibrinolysis).

  After Induction- Prior to Drug Administration, Immediately after Bolus Dose

• Plasminogen Activator Inhibitor-1

  Baseline -Immediately after induction and prior to administration of study drug

Study Arms (3)

. Tranexamic acid low dose 10 mg/kg

EXPERIMENTAL

Drug: Tranexamic acid 10mg/kg/hr

Tranexamic acid 100mg/kg

EXPERIMENTAL

Drug: Tranexamic acid 100 mg/kg/h infusion

Saline Placebo

PLACEBO COMPARATOR

Drug: Saline solution

Interventions

Tranexamic acid 10mg/kg/hr DRUG

Tranexamic acid is a synthetic antifibrinolytic drug that competitively inhibits the lysine binding sites of plasminogen, plasmin, and tissue plasminogen activator

Also known as: TXA

. Tranexamic acid low dose 10 mg/kg

Tranexamic acid 100 mg/kg/h infusion DRUG

Tranexamic acid is a synthetic antifibrinolytic drug that competitively inhibits the lysine binding sites of plasminogen, plasmin, and tissue plasminogen activator.

Also known as: TXA

Tranexamic acid 100mg/kg

Saline solution DRUG

Saline placebo

Saline Placebo

Eligibility Criteria

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

You may qualify if:

• \. Children with secondary scoliosis undergoing posterior spinal fusion

You may not qualify if:

• Known bleeding disorder as this may increase the risk of bleeding
• Current antifibrinolytic therapy as these patients may bleed less
• Patient or family history of thromboembolic disease as there may be potential risk of thrombosis
• Use of NSAIDS within 5 days of surgery as this may increase the risk of bleeding
• Known allergy to TXA
• History of renal insufficiency as TXA is renally excreted
• Colour vision disturbance

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

Hospital for Sick Children

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Scoliosis

Interventions

Tranexamic Acid; Saline Solution

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Tara Der, M.sc. MD.,(FRCPC)

  Hospital for SickkIds

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Anaesthesiologist

Study Record Dates

• First Submitted: March 11, 2010
• First Posted: March 18, 2010
• Study Start: November 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: July 15, 2019

Record last verified: 2019-07

Locations

CA (1)