Tranexamic Acid for Hemorrhage

Overseen By Kristen A Ban, MD MS

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Kristen Ban

Disqualifiers: Dialysis, Pregnancy, Thromboembolism, DIC, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

394 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if tranexamic acid (TXA), a medication, can reduce bleeding during and after major colorectal surgery. Researchers seek to assess whether TXA lowers the need for blood transfusions, additional procedures for bleeding, or serious complications like strokes or heart attacks. Participants will be divided into two groups: one receiving TXA and the other not receiving it. This trial may suit adults undergoing inpatient colorectal surgery who do not have severe kidney issues or a history of blood clots. As a Phase 2 trial, this research focuses on measuring TXA's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that tranexamic acid is likely to be safe for humans?

Research has shown that tranexamic acid (TXA) is generally safe for people. A large safety review examined over 16 million reports and found only 1,574 mentioned side effects related to TXA, indicating that serious side effects are rare.

Studies have found that TXA can reduce bleeding without increasing the risk of dangerous blood clots, such as those in deep veins or the lungs. For instance, TXA has been safely used to control bleeding in various medical situations, including severe bleeding after childbirth.

The current clinical trial is in the early stages (Phase 2), focusing on safety and dosage. Previous evidence suggests TXA is safe to use. Participants will be closely monitored for any issues. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Tranexamic Acid is unique because it directly helps reduce bleeding by preventing blood clots from breaking down too quickly. Most treatments for hemorrhage, like blood transfusions or surgical interventions, focus on replacing lost blood or stopping the source of bleeding. Tranexamic Acid works differently by enhancing the body's natural ability to form stable clots, which can significantly minimize blood loss during surgeries. Researchers are particularly excited about its potential to be administered quickly and effectively during surgical procedures, potentially reducing the need for more invasive measures.

What evidence suggests that tranexamic acid might be an effective treatment for reducing bleeding during and after major colorectal surgery?

This trial will compare the effects of Tranexamic Acid (TXA) with a control group receiving standard care without TXA. Studies have shown that TXA can help reduce severe bleeding. Research indicates that TXA improves survival in patients with major bleeding when administered within 3 hours of injury. Additionally, a review of studies found that TXA reduces deaths from bleeding in women by about 19%. This suggests TXA might effectively lower bleeding risks during surgeries, such as major colorectal surgery. However, monitoring for any increased risk of blood clots is important. ^{1 5 6 7 8}

Who Is on the Research Team?

Kristen A Ban, MD MS

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

This trial is for patients scheduled for major colorectal surgery who are at risk of bleeding. They should not have a history of blood clots, pulmonary hypertension, or be allergic to Tranexamic Acid (TXA). Participants must be willing to potentially receive TXA before their operation.

Inclusion Criteria

I am scheduled for or have had abdominal or pelvic surgery for colorectal issues.

Exclusion Criteria

My kidney function is low, with a creatinine clearance under 30 mL/min.

Known defective color vision (color blind)

I am on long-term dialysis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Treatment

Participants receive 1 g TXA IV at the beginning and end of surgery in the operating room

1 day

1 visit (in-person)

Postoperative Monitoring

Participants are monitored for changes in hemoglobin and bleeding complications within 30 days of surgery

30 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

What Are the Treatments Tested in This Trial?

Interventions

• Tranexamic Acid

Trial Overview The study tests if giving patients Tranexamic Acid (TXA) before colorectal surgery can reduce bleeding during and after the procedure. It also looks at whether TXA lowers the need for blood transfusions or additional surgeries due to bleeding, without increasing the risk of blood clots.

How Is the Trial Designed?

Group I: Tranexamic Acid Experimental Treatment 1 Intervention

TXA administered as a 1 gram IV bolus in 100ml of normal saline administered over 10 minutes at the start and end of the surgery for a total of 2 grams TXA

Group II: Control (no tranexamic acid) Active Control 1 Intervention

Standard of care

Tranexamic Acid is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Tranexamic Acid for:

• Heavy menstrual bleeding
• Prevention of excessive bleeding during surgeries

Approved in European Union as Tranexamic Acid for:

• Heavy menstrual bleeding
• Prevention of excessive bleeding during surgeries
• Hereditary angioedema

Approved in Canada as Tranexamic Acid for:

• Heavy menstrual bleeding
• Prevention of excessive bleeding during surgeries

Approved in Japan as Tranexamic Acid for:

• Heavy menstrual bleeding
• Prevention of excessive bleeding during surgeries

Who Is Running the Clinical Trial?

Kristen Ban

Lead Sponsor

Trials

1

Recruited

390+

Published Research Related to This Trial

A systematic review and meta-analysis of four studies involving 2,347 trauma patients showed that prehospital administration of tranexamic acid (TXA) significantly reduces early mortality (within 24 hours) compared to no TXA, with an odds ratio of 0.60.

The use of TXA did not increase the risk of venous thromboembolism, indicating it is a safe intervention for managing bleeding in trauma patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of prehospital TXA on mortality among bleeding trauma patients: A systematic review and meta-analysis. Almuwallad, A., Cole, E., Ross, J., et al.[2023]

Tranexamic acid (TXA) significantly reduces perioperative blood loss in total shoulder arthroplasty (TSA), with a notable decrease in hemoglobin change, drain output, and total blood loss, particularly after reverse TSA, based on a meta-analysis of 6 studies involving 680 patients.

While TXA shows a trend towards reducing transfusion rates after reverse TSA, it did not significantly affect transfusion rates after anatomic TSA, indicating a need for further research to clarify its efficacy in different TSA types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tranexamic acid administration for anatomic and reverse total shoulder arthroplasty: a systematic review and meta-analysis. Box, HN., Tisano, BS., Khazzam, M.[2022]

Tranexamic acid (TXA) significantly reduces the rate of hematoma expansion in patients with traumatic brain injury (TBI), which can lead to lower mortality rates and improved neurologic outcomes, based on a systematic review of 5 randomized controlled trials involving 917 patients.

The effectiveness of TXA is enhanced when treatment is administered early, and it does not increase the risk of thrombosis events, indicating it is a safe option for managing hemorrhage in TBI patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Tranexamic Acid in Patients with Traumatic Brain Injury: A Systematic Review and Meta-Analysis. Weng, S., Wang, W., Wei, Q., et al.[2019]

A systematic review of 57 studies involving 5,049 patients found that the antifibrinolytic drug tranexamic acid (TXA) has a low frequency of thrombotic events, with less than 1% incidence of limb ischaemia and myocardial infarction.

For patients treated with TXA or epsilonaminocaproic acid (EACA) after spontaneous bleeding, the occurrence of deep vein thrombosis or pulmonary embolism was 1.9% and 3.0%, respectively, indicating that these drugs are generally safe, especially outside of subarachnoid haemorrhage cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The frequency of thrombotic events among adults given antifibrinolytic drugs for spontaneous bleeding: systematic review and meta-analysis of observational studies and randomized trials. Ross, J., Al-Shahi Salman, R.[2022]

Tranexamic acid (TXA) significantly reduces total blood loss in patients undergoing hip arthroplasty, with a weighted mean difference favoring TXA compared to controls (P<0.001).

While there is a trend towards fewer patients requiring blood transfusions in the TXA group, this result was not statistically significant, indicating that TXA is effective for reducing bleeding but may not drastically lower transfusion needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficiency of tranexamic acid in perioperative blood loss in hip arthroplasty: a systematic literature review and meta-analysis. Pinzón-Florez, CE., Vélez Cañas, KM., Díaz Quijano, DM.[2018]

Tranexamic acid (TXA) was successfully used to achieve hemostasis in a 72-year-old male patient on rivaroxaban, who experienced persistent bleeding after a biopsy, demonstrating its potential effectiveness in patients on direct oral anticoagulants (DOACs).

The intervention was simple, cost-effective, and required minimal resources, providing a novel approach to manage uncontrollable bleeding in anticoagulated patients when traditional methods were ineffective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical Tranexamic Acid for Hemostasis of an Oral Bleed in a Patient on a Direct Oral Anticoagulant. Boccio, E., Hultz, K., Wong, AH.[2022]

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 ... Outcomes. The primary effectiveness outcome was life-threatening bleeding (a composite outcome defined as death or any of the following ...

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7271662/

Effect of tranexamic acid by baseline risk of death in acute ... Tranexamic acid appears to be safe and effective regardless of baseline risk of death. Because many deaths are in patients at low and intermediate risk.

5. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2024.1416998/full

Tranexamic acid: a narrative review of its current role in ... Death due to bleeding within 5 days (the primary outcome) occurred in 222 (4%) of 5,956 patients in the TXA group and in 226 (4%) of 5,981 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8356407/

Tranexamic acid for the prevention and treatment of bleeding ... The only outcome for which TXA might be beneficial is growth of the hemorrhagic mass. Multiple studies indicated that TXA, in the same dose as ...

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

Safety assessment of tranexamic acid: real-world adverse ... Results: After analyzing 16,692,026 adverse event reports, a total of 1,574 cases of adverse events related to TXA were identified, spanning 23 system organ ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0020138322009792

Efficacy of high dose tranexamic acid (TXA) for hemorrhage When compared to standard dose, high dose IV TXA probably reduces transfusion requirements with an uncertain effect on thromboembolic events and mortality.