Blood Loss and Transfusion Requirement in Infants Treated With Tranexamic Acid

NCT01094977 | Suspended Phase 3

• 1 other identifier: 1000013836
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Craniosynostoses

Keywords

Blood Loss and Transfusion; Craniosynostoses; Tranexamic Acid; Children

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Plasminogen Activator Inhibitor-1 (PAI-1) Polymorphism - Samples

  Sample will be drawn immediately after induction and prior to administration of study drug

• Thromboelastography (TEG)Sample

  Baseline, immediately after bolus dose of TXA is infused

Study Arms (3)

Low Dose

EXPERIMENTAL

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

Drug: Tranexamic Acid

High Dose

EXPERIMENTAL

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

Drug: Tranexamic Acid

Placebo

PLACEBO COMPARATOR

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

Drug: Saline Placebo

Interventions

Tranexamic Acid DRUG

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

Low Dose

Saline Placebo DRUG

Placebo

Eligibility Criteria

• Age: 2 Months - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Craniosynostoses; Hemorrhage

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Synostosis; Dysostoses; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Tara Der, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Anesthesiologist

Study Record Dates

• First Submitted: March 23, 2010
• First Posted: March 29, 2010
• Study Start: January 1, 2010
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: July 15, 2019

Record last verified: 2019-07

Locations

CA (1)