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Blood Loss and Transfusion Requirement in Infants Treated With Tranexamic Acid

NCT01094977 · Status: SUSPENDED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2019-07-15

No results posted yet for this study

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

Interventions

DRUG

Tranexamic Acid

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

DRUG

Tranexamic Acid

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

DRUG

Saline Placebo

Sponsors & Collaborators

  • The Hospital for Sick Children

    lead OTHER

Principal Investigators

  • Tara Der, MD · The Hospital for Sick Children

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2020-01-31
Completion
2020-01-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01094977 on ClinicalTrials.gov