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

Trial Summary

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 data supports the effectiveness of the drug Tranexamic Acid for reducing bleeding?

Research shows that Tranexamic Acid can reduce bleeding in various situations, such as surgeries and traumatic injuries. For example, in trauma patients, it has been found to lower the risk of death from bleeding when given quickly after injury. ^{1 2 3 4 5}

Is tranexamic acid generally safe for humans?

Tranexamic acid is generally considered safe for humans, with studies showing it reduces bleeding without significant safety issues. However, high doses may cause neurological events, and more research is needed on its effects on blood clots after surgery. ^{6 7 8 9 10}

How does the drug Tranexamic Acid differ from other treatments for bleeding?

Tranexamic Acid is unique because it works by preventing the breakdown of blood clots, which helps control bleeding in various situations like surgery and trauma. Unlike some other treatments, it can be applied topically to reduce blood loss during surgeries, minimizing the need for blood transfusions. ^{4 11 12 13 14}

What is the purpose of this trial?

Although procedural abortion in the second trimester is extremely safe, hemorrhage is one of the leading causes of morbidity and mortality. Tranexamic acid (TXA) is used commonly in obstetrics to prevent or manage intrapartum or postpartum hemorrhage and has been associated with decreased mortality and decreased blood loss at the time of birth. Some guidelines are recommending the use of TXA for both the prevention and management of bleeding for abortion care. However, there are currently no published studies assessing the association between TXA and bleeding outcomes for abortion procedures. This study will involve a randomized, placebo-controlled trial of pregnant patients aged 18 and older desiring dilation and evacuation (D\&E) for abortion or fetal demise at 18-24 weeks gestation. The primary aim is to determine whether prophylactic TXA has an effect on the need for additional interventions to control bleeding at the time of D\&E. The secondary aim is to determine whether prophylactic TXA has an effect on the mean quantitative procedural blood loss.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Brazil pubmed.ncbi.nlm.nih.gov

Evaluation of the use of tranexamic acid in total knee arthroplasty. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

The Effect of Tranexamic Acid on Functional Outcomes: An Exploratory Analysis of the CRASH-2 Randomized Controlled Trial. [2021]

3. France pubmed.ncbi.nlm.nih.gov

Trauma and severe bleeding. Tranexamic acid within one hour to reduce mortality. [2013]

4. United States pubmed.ncbi.nlm.nih.gov

Tranexamic Acid for Traumatic Injury in the Emergency Setting: A Systematic Review and Bias-Adjusted Meta-Analysis of Randomized Controlled Trials. [2023]

5. England pubmed.ncbi.nlm.nih.gov

A high-dose 24-hour tranexamic acid infusion for the treatment of significant gastrointestinal bleeding: HALT-IT RCT. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Association of Tranexamic Acid Administration With Mortality and Thromboembolic Events in Patients With Traumatic Injury: A Systematic Review and Meta-analysis. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Tranexamic acid for the prevention and treatment of bleeding in surgery, trauma and bleeding disorders: a narrative review. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

The effectiveness and safety of tranexamic acid in bilateral total knee arthroplasty: A meta-analysis. [2018]

9. England pubmed.ncbi.nlm.nih.gov

The current place of tranexamic acid in the management of bleeding. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Evidence supports wider use of tranexamic acid in traumatic bleeding. [2017]

11. Iran pubmed.ncbi.nlm.nih.gov

The Effects of Tranexamic Acid on Bleeding Control During and after Percutaneous Nephrolithotomy (PCNL): A Randomized Clinical Trial. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Topical application of tranexamic acid reduces postoperative blood loss in total knee arthroplasty: a randomized, controlled trial. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Tranexamic acid corrects fibrinolysis in the presence of acidemia in a swine model of severe ischemic reperfusion. [2014]

14. Brazil pubmed.ncbi.nlm.nih.gov

Does topical application of tranexamic acid reduce intraoperative bleeding in sinus surgery during general anesthesia? [2022]