Blood Loss and Transfusion Requirement in Infants Treated With Tranexamic Acid

Craniosynostoses Clinical Trial

Official title:

Blood Loss and Transfusion Requirement in Infants Treated With Tranexamic Acid Undergoing Craniosynostosis Reconstruction: A Randomized Placebo-Controlled Double Blind Study of Low and High Dose Therapy

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01094977
• Other study ID #: 1000013836
• Status: Suspended
• Phase: Phase 3
• Start date: January 2010
• Est. completion date: January 2020

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

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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 90
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Months to 2 Years

Eligibility

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.

Related Conditions & MeSH terms

• Craniosynostoses
• Hemorrhage

Intervention

Drug:
• Tranexamic Acid
10 mg/kg bolus with a 5 mg/kg/h infusion
• Tranexamic Acid
100 mg/kg bolus with a 10 mg/kg/h infusion
• Saline Placebo

Locations

Country	Name	City	State
Canada	The 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	Blood Loss	Blood loss will be carefully measured in sponges, suction cannisters, cell saver systems, and in the plastic pockets of surgical drapes.	Prior and Post Surgery
Secondary	Plasminogen Activator Inhibitor-1 (PAI-1) Polymorphism - Samples	PAI-1 promotes clot stability and the PAI-1 polymorphism will affect the degree of bleeding and response to TXA during craniosynostosis surgery	Sample will be drawn immediately after induction and prior to administration of study drug
Secondary	Thromboelastography (TEG)Sample	TEG monitors coagulation of blood samples in vitro to produce a complete picture of clot formation, strength and dissolution (i.e. fibrinolysis)	Baseline, immediately after bolus dose of TXA is infused