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
Verified date | July 2019 |
Source | The Hospital for Sick Children |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Canada | The Hospital for Sick Children | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
The Hospital for Sick Children |
Canada,
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 |
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