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Anti-fibrinolytic

Tranexamic Acid Injectable Solution for Pelvic Organ Prolapse

Phase 3

Waitlist Available

Led By Colleen McDermott, MD

Research Sponsored by Mount Sinai Hospital, Canada

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 4 weeks

Awards & highlights

Study Summary

This trial will be double-blind, meaning that neither the participants nor the researchers will know who is receiving the tranexamic acid or the placebo until after the trial is completed. This is important because it helps to ensure that the results are not biased. The trial will be placebo-controlled, which means that half of the participants will receive the tranexamic acid and half will receive a placebo (a medication with no active ingredient). The trial will be randomized, which means that the participants will be assigned to either the tranexamic acid group or the placebo group by chance.

Eligible Conditions

Pelvic Organ Prolapse

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in hemoglobin

Secondary outcome measures

Blood loss

Change in hematocrit

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Tranexamic AcidExperimental Treatment1 Intervention

Tranexamic Acid Injectable Solution (1g intravenous) Single dose prior to the start of surgery, after the induction of anesthesia

Group II: PlaceboPlacebo Group1 Intervention

67mL intravenous normal saline (0.9% sodium chloride) Single dose prior to the start of surgery, after the induction of anesthesia

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tranexamic Acid Injectable Solution

2017

Completed Phase 4

~4870

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Mount Sinai Hospital, CanadaLead Sponsor

196 Previous Clinical Trials

67,578 Total Patients Enrolled

2 Trials studying Pelvic Organ Prolapse

57 Patients Enrolled for Pelvic Organ Prolapse

Colleen McDermott, MDPrincipal InvestigatorMount Sinai Hospital - University of Toronto

Frequently Asked Questions

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

Can you provide more information on Tranexamic Acid Injectable Solution's clinical efficacy?

"As of right now, there are 69 ongoing studies investigating Tranexamic Acid Injectable Solution. Of those, 29 are in Phase 3. Although the majority of these trials are based in Kansas City, Kansas, there are 305 research sites running these studies."

Answered by AI

Are people who are over the age of 50 able to participate in this experiment?

"The ideal participants for this trial are those who are between 18 and 100 years old."

Answered by AI

What is Tranexamic Acid Injectable Solution designed to alleviate?

"Tranexamic Acid Injectable Solution is used to treat hyperfibrinolysis, and can also be applied to patients with hemophilia or who are bleeding following a tooth extraction."

Answered by AI

Is there a danger in using Tranexamic Acid Injectable Solution?

"There is clinical evidence backing up the safety of Tranexamic Acid Injectable Solution, which is why it received a 3 on our Power scale."

Answered by AI

Who might this clinical trial be most beneficial for?

"Eligibility requirements for this study includes having pelvic organ prolapse and being between 18 to 100 years old. Currently, the study is looking to enrol 30 individuals."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Does Intravenous Tranexamic Acid Reduce Blood Loss During Vaginectomy?

2018. "Does Intravenous Tranexamic Acid Reduce Blood Loss During Vaginectomy?". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03216083.