Non-Idiopathic Scoliosis Treated With Tranexamic Acid

NCT ID: NCT01089140

Last Updated: 2019-07-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2014-11-30

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.

Detailed Description

To investigate whether tranexamic acid (TXA) reduces perioperative blood loss and transfusion requirement in pediatric patients with secondary scoliosis undergoing posterior spinal fusion.In addition determination of the optimal TXA dosing for perioperative reduction of blood loss and transfusion requirement as well as to evaluate use of thromboelastography (TEG) as a measure of coagulation and fibrinolysis in pediatric patients with secondary scoliosis undergoing posterior spinal fusion (this may help guide blood product therapy).

The investigation will determine the effects of TXA on the TEG profile and whether plasminogen activator inhibitor-1 (PAI-1) level affects bleeding and transfusion requirement during scoliosis surgery. Finally to investigate whether PAI-1 level affects bleeding in response to TXA during scoliosis surgery.

Conditions

Non-idiopathic Scoliosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

. Tranexamic acid low dose 10 mg/kg

Group Type: EXPERIMENTAL

Tranexamic acid 10mg/kg/hr

Intervention Type: DRUG

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

Tranexamic acid 100mg/kg

Group Type: EXPERIMENTAL

Tranexamic acid 100 mg/kg/h infusion

Intervention Type: DRUG

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

Saline Placebo

Group Type: PLACEBO_COMPARATOR

Saline solution

Intervention Type: DRUG

Saline placebo

Interventions

Tranexamic acid 10mg/kg/hr

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

Intervention Type: DRUG

Tranexamic acid 100 mg/kg/h infusion

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

Intervention Type: DRUG

Saline solution

Saline placebo

Intervention Type: DRUG

Other Intervention Names

TXA; TXA

Eligibility Criteria

Inclusion Criteria

1. Children with secondary scoliosis undergoing posterior spinal fusion

Exclusion Criteria

1. Known bleeding disorder as this may increase the risk of bleeding

2. Current antifibrinolytic therapy as these patients may bleed less

3. Patient or family history of thromboembolic disease as there may be potential risk of thrombosis

4. Use of NSAIDS within 5 days of surgery as this may increase the risk of bleeding

5. Known allergy to TXA

6. History of renal insufficiency as TXA is renally excreted

7. Colour vision disturbance

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Tara Der

Staff Anaesthesiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tara Der, M.sc. MD.,(FRCPC)

Role: PRINCIPAL_INVESTIGATOR

Hospital for SickkIds

Locations

Hospital for Sick Children

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

1000013524

Identifier Type: -

Identifier Source: org_study_id