Non-Idiopathic Scoliosis Treated With Tranexamic Acid

The Hospital for Sick Children

Status and phase: Terminated; Phase 2

Conditions: Non-idiopathic Scoliosis

Treatments: Drug: Saline solution; Drug: Tranexamic acid 100 mg/kg/h infusion; Drug: Tranexamic acid 10mg/kg/hr

Study type: Interventional

Funder types: Other

Identifiers

NCT01089140

1000013524

Details and patient eligibility

About

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

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 8 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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2 participants in 3 patient groups, including a placebo group

. Tranexamic acid low dose 10 mg/kg

Experimental group

Treatment:

Drug: Tranexamic acid 10mg/kg/hr

Tranexamic acid 100mg/kg

Experimental group

Treatment:

Drug: Tranexamic acid 100 mg/kg/h infusion

Saline Placebo

Placebo Comparator group

Treatment:

Drug: Saline solution