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Antifibrinolytic agent

Tranexamic Acid for Postpartum Hemorrhage

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

Study 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pharmacodynamics of Tranexamic acid
Pharmacokinetics of Tranexamic Acid
Secondary outcome measures
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

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
2,679 Previous Clinical Trials
6,910,566 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,814 Previous Clinical Trials
47,291,028 Total Patients Enrolled

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals aged 55 and above applicable for enrollment in this clinical experiment?

"This trial requires that prospective participants are between 18 and 49 years old, meeting the predefined age criteria."

Answered by AI

What ailments has Tranexamic Acid been demonstrated to ameliorate?

"Tranexamic Acid is often recommended as a therapeutic solution for hyperfibrinolysis. Additionally, it has been found to be beneficial in the treatment of hemophilia, dental bleeding resulting from extractions, and other similar conditions."

Answered by AI

What adverse reactions have been documented from Tranexamic Acid use?

"Evidence backing tranexamic acid's safety is still in its infancy, so it was assigned a score of 2 on the Power scale. This rating reflects that while there are some studies attesting to this medication's security, none have confirmed efficacy yet."

Answered by AI

Is there a current call for participants in this experimental endeavor?

"At this juncture, this clinical trial is not recruiting new patients. First posted on February 1st 2018 and last updated October 17th 2022, it may be worth looking into the 362 trials for postpartum haemorrhage or the 61 studies concerning Tranexamic Acid that are actively seeking participants."

Answered by AI

Has Tranexamic Acid been previously tested in a medical experiment?

"At present, 61 scientific trials for Tranexamic Acid are in progress. Of those studies, 26 have advanced to Phase 3. Kansas City is the epicentre of these experiments; however, 185 other sites around the world are carrying out research regarding this treatment."

Answered by AI

How extensive is the participation in this clinical trial?

"This study has ceased recruitment processes for the time being. Initially posted on February 1st 2018, it was most recently updated on October 17th 2022. For those looking to participate in research related to postpartum hemorrhage, 362 trials are currently recruiting and 61 studies involving Tranexamic Acid are actively enrolling patients as well."

Answered by AI

Who is eligible to sign up for the clinical trial?

"This clinical trial is admitting 30 individuals between 18 and 49 who have been diagnosed with postpartum hemorrhage. Furthermore, the American Congress of Obstetricians and Gynecologists criteria must be met for women undergoing medically indicated or elective cesarean section at greater than 34+0 weeks gestation or 39+0 weeks gestation respectively."

Answered by AI
~4 spots leftby Mar 2025