Tranexamic Acid for Bleeding

Recruiting at 1 trial location

Overseen By Karen Greiner, MD, MPH

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: University of California, San Diego

Must not be taking: Anticoagulants

Disqualifiers: Thromboembolic event, Coagulopathy, Renal impairment, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 1 day

276 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether tranexamic acid, a medication used to reduce bleeding, can help during certain second-trimester abortion procedures. The study compares tranexamic acid to a placebo to determine if it reduces the need for additional treatments to control bleeding. It targets pregnant individuals experiencing fetal demise or seeking an abortion between 18 and 24 weeks of pregnancy. Participants should not have a history of blood clots or be using blood thinners. As a Phase 4 trial, this research aims to understand how this FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you've used anticoagulants (blood thinners) in the last five days.

What is the safety track record for tranexamic acid?

Research has shown that tranexamic acid (TXA) is generally safe for reducing bleeding. Studies indicate that TXA lowers the risk of bleeding and can reduce the chance of death from bleeding events. Importantly, TXA usually does not increase the risk of blood clots, a major concern with many blood-related treatments.

The FDA has approved TXA for treating heavy menstrual bleeding and for short-term use in people with hemophilia, suggesting it is well-tolerated for these conditions.

In surgery, TXA has reduced bleeding without increasing heart-related risks, providing further evidence of its safety. Overall, the data supports TXA as a safe option for managing bleeding in various situations. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about tranexamic acid for managing bleeding because it stands out from current treatments by directly enhancing blood clot stability. Most treatments for bleeding focus on replacing lost blood components or providing general clotting support, but tranexamic acid works by inhibiting the breakdown of fibrin, a key part of blood clots. This unique mechanism can potentially reduce bleeding more efficiently and quickly, offering a targeted approach that complements traditional methods. Additionally, tranexamic acid's intravenous administration allows for rapid action, which is crucial in acute bleeding situations.

What evidence suggests that tranexamic acid might be an effective treatment for bleeding during second-trimester abortion procedures?

Research has shown that tranexamic acid (TXA) helps reduce bleeding in many medical situations. Studies have found that TXA significantly lowers the risk of severe bleeding and reduces blood loss during surgery and childbirth. For example, one study found it decreased the risk of life-threatening bleeding in women after childbirth. Another study showed fewer deaths from bleeding when TXA was used. In this trial, participants will receive either TXA or a placebo to evaluate its effectiveness in controlling bleeding during procedures like second-trimester abortions, although specific studies for this use have not yet been published. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for pregnant patients aged 18 and older who are planning to undergo a dilation and evacuation (D&E) procedure for abortion or fetal demise at 18-24 weeks gestation. Specific eligibility criteria details were not provided.

Inclusion Criteria

Able to understand and sign informed consent

Requesting pregnancy termination or procedural management of fetal demise - Intrauterine pregnancy, 18 weeks 0 days and 24 weeks and 0 days gestation

Exclusion Criteria

Suspected placenta accreta spectrum

I will receive medication other than oxytocin to prevent bleeding during my procedure.

Known allergic reaction or hypersensitivity to TXA

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either 1g tranexamic acid or placebo via IV at the start of the D&E procedure

1 day

1 visit (in-person)

Immediate Follow-up

Participants are monitored for bleeding outcomes and adverse events immediately after the D&E procedure

4 hours

1 visit (in-person)

Follow-up

Participants are monitored for any adverse events and overall safety after the procedure

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Tranexamic Acid

Trial Overview The study tests whether Tranexamic Acid (TXA), compared to a placebo, can reduce the need for additional interventions to control bleeding during D&E procedures in the second trimester. It's a randomized, controlled trial focusing on blood loss outcomes.

How Is the Trial Designed?

Group I: Tranexamic acid Active Control 1 Intervention

1g tranexamic acid administered via IV at the start of the D\&E procedure

Group II: Placebo Placebo Group 1 Intervention

10 mL of normal saline administered via IV at the start of the D\&E procedure

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK532909/

Tranexamic Acid - StatPearls - NCBI Bookshelf The study data suggest that TXA improves survival when administered within 3 hours of the injury in patients with significant hemorrhage.[4][5] ...

2. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(24)02102-0/fulltext

Tranexamic acid for postpartum bleeding: a systematic ... We found strong evidence that tranexamic acid reduces life-threatening bleeding. This result was mainly driven by data from the WOMAN trial,.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1538783623007353

When to use tranexamic acid for the treatment of major ... The study reported fewer deaths due to bleeding in women who received TXA (1.5% vs 1.9%; risk ratio: 0.81; 95% CI: 0.65-1.00; P = .045). There was no difference ...

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa2215457

Prehospital Tranexamic Acid for Severe Trauma Our data do not preclude the possibility that tranexamic acid can prevent early death from bleeding in some patients who will go on to make a good recovery.

5. haematologica.org haematologica.org/article/view/9375

The never ending success story of tranexamic acid in ... TXA has arisen following evidence that it has a beneficial effect in reducing blood loss in a variety of medical and surgical conditions at increased risk of ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2475037922014091

Tranexamic acid evidence and controversies: An illustrated ... Tranexamic acid (TXA) decreases the risk of bleeding and often the risk of death from bleeding. · In general, TXA does not increase the risk of blood clots.

7. frontiersin.org frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2024.1388138/full

Safety assessment of tranexamic acid: real-world adverse ... This study analyzed real-world data from the US Food and Drug Administration to investigate TXA-related adverse events, aiming to elucidate its safety and ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39813061/

Safety and Efficacy of Tranexamic Acid in General Surgery In this study, TXA significantly reduced the risk of perioperative bleeding without increasing cardiovascular risk in patients undergoing general surgery ...

9. mayoclinic.org mayoclinic.org/drugs-supplements/tranexamic-acid-oral-route/description/drg-20073517

Tranexamic acid (oral route) - Side effects & dosage Tranexamic acid is used to treat heavy menstrual bleeding in women. ... Safety and efficacy have not been established. Geriatric.