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Antifibrinolytic agent

Tranexamic Acid 2 Gram for Laser Injury (TAMPITI Trial)

Phase 2
Waitlist Available
Led By Philip C Spinella, MD
Research Sponsored by Washington University School of Medicine
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 samples drawn through 72 hours after study initiation
Awards & highlights
All Individual Drugs Already Approved

Summary

The purpose of this study is to evaluate the effects of TXA on the immune system, its pharmacokinetics, as well as safety and efficacy in severely injured trauma patients.

Eligible Conditions
  • Laser Injury
  • Bleeding
  • Wounds and Injuries
  • Shock

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~samples drawn through 72 hours after study initiation
This trial's timeline: 3 weeks for screening, Varies for treatment, and samples drawn through 72 hours after study initiation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Monocytes
Secondary study objectives
CL- Clearance of TXA (mL/(Min*70kg))
Creatinine Count CL
Determine the Incidence of All Adverse Events in All Three Study Groups
+10 more

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.

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Tranexamic Acid 4 GramExperimental Treatment1 Intervention
One time dose IV TXA 4 Grams given over 10 minutes within 2 hours of initial injury
Group II: Tranexamic Acid 2 GramExperimental Treatment1 Intervention
One time dose IV TXA 2 Grams given over 10 minutes within 2 hours of initial injury
Group III: PlaceboPlacebo Group1 Intervention
Matching Volume Normal Saline Placebo given IV over 10 minutes within 2 hours of initial injury
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?

Washington University School of MedicineLead Sponsor
1,991 Previous Clinical Trials
2,295,734 Total Patients Enrolled
United States Department of DefenseFED
909 Previous Clinical Trials
333,546 Total Patients Enrolled
Philip C Spinella, MDPrincipal InvestigatorWashington University School of Medicine
2 Previous Clinical Trials
2,000 Total Patients Enrolled
~15 spots leftby Nov 2025
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