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Antifibrinolytic agent

Tranexamic Acid for Bleeding (TXA Trial)

Phase 3
Waitlist Available
Led By Rebecca Clifton, Ph.D.
Research Sponsored by The George Washington University Biostatistics Center
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 from 4 weeks before delivery to 48 hours postpartum
Awards & highlights

Summary

This trial found that tranexamic acid lowered the risk of postpartum hemorrhage in women undergoing a cesarean delivery.

Eligible Conditions
  • Bleeding
  • Obstetric Complications
  • Childbirth

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from 4 weeks before delivery to 48 hours postpartum
This trial's timeline: 3 weeks for screening, Varies for treatment, and from 4 weeks before delivery to 48 hours postpartum for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants With Maternal Death or Transfusion of Packed Red Blood Cells
Secondary study objectives
Change in Hemoglobin
Length of Stay
Number of Participants Who Received Open Label TXA or Other Antifibrinolytic
+9 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

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Tranexamic AcidExperimental Treatment1 Intervention
Tranexamic Acid for intravenous administration
Group II: PlaceboPlacebo Group1 Intervention
Normal saline for intravenous administration
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tranexamic Acid
2011
Completed Phase 4
~2740

Find a Location

Who is running the clinical trial?

The George Washington University Biostatistics CenterLead Sponsor
25 Previous Clinical Trials
92,332 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,014 Previous Clinical Trials
2,685,834 Total Patients Enrolled
1 Trials studying Bleeding
40 Patients Enrolled for Bleeding
Monica Longo, MDStudy DirectorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
8 Previous Clinical Trials
37,079 Total Patients Enrolled
~1467 spots leftby Sep 2025
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