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Antifibrinolytic

Tranexamic Acid for Surgery

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 up to 5 years
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

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
  • Surgery
  • Broken Bones

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
195 Previous Clinical Trials
144,305 Total Patients Enrolled
1 Trials studying Surgery
550 Patients Enrolled for Surgery
Dirk W Kiner, MDPrincipal InvestigatorUTCOM Chattanooga / Erlanger Health System
1 Previous Clinical Trials
11 Total Patients Enrolled
~7 spots leftby Nov 2025