MedTrace Logo

Efficacy of Amicar for Children Having Craniofacial Surgery

NCT02229968 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2026-04-07

No results posted yet for this study

Summary

The purpose of this study is to determine whether Amicar (ε-aminocaproic acid) is effective in reducing blood loss in children undergoing craniofacial reconstruction surgery.

The investigators hypothesize that Amicar will decrease intraoperative blood loss and decrease the need for perioperative blood product administration in children undergoing craniofacial surgery.

Conditions

  • Craniosynostosis

Interventions

DRUG

Amicar (ε-aminocaproic acid)

DRUG

normal saline

Sponsors & Collaborators

  • Children's National Research Institute

    lead OTHER

Principal Investigators

  • Srijaya K Reddy, MD, MBA · Vanderbilt University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2028-01-31
Completion
2028-03-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT02229968 on ClinicalTrials.gov