Blood Loss and Transfusion Requirement in Infants Treated With Tranexamic Acid

NCT ID: NCT01094977

Last Updated: 2019-07-15

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE3
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2020-01-31

Brief Summary

The primary objective of this study is to investigate whether tranexamic acid (TXA) reduces perioperative blood loss and transfusion requirement in infants undergoing craniosynostosis surgery.

Detailed Description

Blood loss during pediatric craniosynostosis surgery can be significant and this may be exacerbated by a dilutional coagulopathy. Multimodal blood conservation strategies may limit allogeneic transfusions, although RCTs are few and limited. It is essential to investigate these techniques to determine their potential to reduce allogeneic blood transfusions and their associated cost and morbidity.

Tranexamic acid (TXA) is a synthetic antifibrinolytic drug that competitively inhibits the lysine binding sites of plasminogen, plasmin, and tissue plasminogen activator. The result is inhibition of fibrinolysis and clot degradation.

Recent studies in adults undergoing cardiac surgery demonstrated that people with 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 and the PAI-1 polymorphism will affect the degree of bleeding and response to TXA during craniosynostosis surgery.

Conditions

Craniosynostoses

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Low Dose

TXA 10mg/kg bolus before incision and 5 mg/kg infusion until skin closure

Group Type: EXPERIMENTAL

Tranexamic Acid

Intervention Type: DRUG

10 mg/kg bolus with a 5 mg/kg/h infusion

High Dose

TXA 100 mg/kg bolus before incision and 10 mg/kg infusion until skin closure

Group Type: EXPERIMENTAL

Tranexamic Acid

Intervention Type: DRUG

100 mg/kg bolus with a 10 mg/kg/h infusion

Placebo

Normal saline 10 ml before skin incision and infusion according to weight until skin closure

Group Type: PLACEBO_COMPARATOR

Saline Placebo

Intervention Type: DRUG

Interventions

Tranexamic Acid

10 mg/kg bolus with a 5 mg/kg/h infusion

Intervention Type: DRUG

Tranexamic Acid

100 mg/kg bolus with a 10 mg/kg/h infusion

Intervention Type: DRUG

Saline Placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Infants aged 2 months to 2 years undergoing anterior cranial vault reconstruction

Exclusion Criteria

• 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
• Acquired colour vision defects as one of the first signs of long term TXA toxicity is colour vision disturbance.

• Minimum Eligible Age: 2 Months
• Maximum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Tara Der

Staff Anesthesiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tara Der, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Locations

The Hospital for Sick Children

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

1000013836

Identifier Type: -

Identifier Source: org_study_id