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Antifibrinolytic agent

Prevention of Postpartum Hemorrhage With Tranexamic Acid

Phase 2
Waitlist Available
Led By Homa Ahmadzia, MD
Research Sponsored by Homa Ahmadzia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during surgery
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

This trial is testing if giving TXA to women during childbirth can help prevent postpartum hemorrhage, which is a major cause of maternal death.

Eligible Conditions
  • Postpartum Hemorrhage

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during surgery, after surgery while in hospital, 2 weeks and 6 weeks postpartum
This trial's timeline: 3 weeks for screening, Varies for treatment, and during surgery, after surgery while in hospital, 2 weeks and 6 weeks 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
Pharmacodynamics of Tranexamic acid
Pharmacokinetics of Tranexamic Acid
Secondary study objectives
Estimated blood loss
Safety parameters

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

3Treatment groups
Experimental Treatment
Group I: Cohort 3Experimental Treatment1 Intervention
Dose of Tranexamic acid 15 mg/kg will be administered.
Group II: Cohort 2Experimental Treatment1 Intervention
Dose of Tranexamic acid 10 mg/kg will be administered.
Group III: Cohort 1Experimental Treatment1 Intervention
Dose of Tranexamic acid 5mg/kg will be administered.
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?

Homa AhmadziaLead Sponsor
National Institutes of Health (NIH)NIH
2,842 Previous Clinical Trials
8,173,120 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,944 Previous Clinical Trials
47,799,799 Total Patients Enrolled
George Washington UniversityLead Sponsor
255 Previous Clinical Trials
466,610 Total Patients Enrolled
3 Trials studying Postpartum Hemorrhage
439 Patients Enrolled for Postpartum Hemorrhage
Homa Ahmadzia, MDPrincipal InvestigatorGeorge Washington University

Media Library

Tranexamic Acid (Antifibrinolytic agent) Clinical Trial Eligibility Overview. Trial Name: NCT03287336 — Phase 2
Postpartum Hemorrhage Research Study Groups: Cohort 1, Cohort 3, Cohort 2
Postpartum Hemorrhage Clinical Trial 2023: Tranexamic Acid Highlights & Side Effects. Trial Name: NCT03287336 — Phase 2
Tranexamic Acid (Antifibrinolytic agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03287336 — Phase 2
~4 spots leftby Dec 2025
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