Non-Idiopathic Scoliosis Treated With Tranexamic Acid

Non-idiopathic Scoliosis Clinical Trial

Official title:

Blood Loss and Transfusion Requirement in Pediatric Patients With Non-Idiopathic Scoliosis Treated With Tranexamic Acid Undergoing Posterior Spinal Instrumentation and Fusion.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01089140
• Other study ID #: 1000013524
• Status: Terminated
• Phase: Phase 2
• Start date: November 2014
• Est. completion date: November 2014

Study information

• Verified date: July 2019
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Non-idiopathic Scoliosis
• Scoliosis

Intervention

Drug:
• 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
• 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.
• Saline solution
Saline placebo

Locations

Country	Name	City	State
Canada	Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perioperative blood loss and transfusion requirement		8 hours
Secondary	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
Secondary	Plasminogen Activator Inhibitor-1	Different genotypes for the plasminogen activator inhibitor-1 (PAI-1) gene may have varying degrees of bleeding. PAI-1 inhibits the transformation of plasminogen to plasmin thereby decreasing plasmin-induced fibrinolysis. Thus, PAI-1 promotes clot stability.	Baseline -Immediately after induction and prior to administration of study drug