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Antifibrinolytic Agent

Tranexamic acid for Craniosynostosis

Phase 4
Waitlist Available
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up intraoperative and postoperative (24 hr)
Awards & highlights

Study Summary

This trial tests if a drug can reduce bleeding and need for transfusions in kids' craniofacial surgeries.

Eligible Conditions
  • Craniosynostosis
  • Bleeding

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Patients That Remained Transfusion Free
Total Volume (ml/kg) of Allogeneic Blood Exposure.
Secondary outcome measures
Effect of Tranexamic Acid on Prothrombin Time (PT), Partial Thromboplastin Time (PTT) at Three Time Points (Baseline, After Osteotomies, and Immediately After Procedure).
Blood Platelets

Side effects data

From 2012 Phase 4 trial • 100 Patients • NCT00740116
22%
Readmissions
14%
Postoperative infections
10%
Re-operations
4%
Thromboembolic events
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo Group
Tranexamic Group

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Tranexamic acidExperimental Treatment1 Intervention
Tranexamic acid (100 mg/kg load, 10 mg/kg/hr) intravenous
Group II: PlaceboPlacebo Group1 Intervention
Saline was administered intravenously
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tranexamic acid
FDA approved

Find a Location

Who is running the clinical trial?

University of PittsburghLead Sponsor
1,736 Previous Clinical Trials
16,339,103 Total Patients Enrolled
1 Trials studying Craniosynostosis
29 Patients Enrolled for Craniosynostosis
~1 spots leftby Jun 2025
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