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Antifibrinolytic

Tranexamic Acid for Broken Bones

N/A
Waitlist Available
Led By Dirk W Kiner, MD
Research Sponsored by University of Tennessee
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through postoperative day four
Awards & highlights

Study Summary

Tranexamic acid is an antifibrinolytic drug that has been used to decrease post-operative blood loss. This study is a prospective, randomized controlled trial investigating the use of tranexamic acid in fracture surgery around the hip and knee, in which significant blood loss (>300mL) is expected. The hypothesis of this study is that tranexamic acid will be associated with a decrease in post-operative blood loss, as well as a decreased need for allogenic blood transfusion, in patients who have fracture surgery around the hip and knee.

Eligible Conditions
  • Blood Loss
  • Trauma
  • Broken Bones
  • Surgery

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through postoperative day four
This trial's timeline: 3 weeks for screening, Varies for treatment, and through postoperative day four for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
hemoglobin value
Secondary outcome measures
hematocrit value
number of units of allogenic blood transfused

Side effects data

From 2015 Phase 4 trial • 29 Patients • NCT02063035
8%
Postoperative wound infection
8%
Postoperative wound infection after release from hospital
8%
Myocardial infaction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Tranexamic Acid

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Tranexamic AcidExperimental Treatment1 Intervention
15 mg/kg preoperative IV dose followed by another 15 mg/kg IV dose three hours after the initial dose
Group II: ControlActive Control1 Intervention
No tranexamic acid given
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 TennesseeLead Sponsor
189 Previous Clinical Trials
141,928 Total Patients Enrolled
Dirk W Kiner, MDPrincipal InvestigatorUTCOM Chattanooga / Erlanger Health System
1 Previous Clinical Trials
11 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Tranexamic Acid in Orthopaedic Trauma Surgery
2012. "Tranexamic Acid in Orthopaedic Trauma Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02080494.
All > Trauma
~8 spots leftby May 2025
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