Tranexamic Acid for Surgical Bleeding Control

Overseen By Timothy Weber, MD

Age: Any Age

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Alabama at Birmingham

Disqualifiers: Hypertension, Cardiac problems, Bleeding, 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: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether tranexamic acid (TXA) can effectively control bleeding during jaw surgery without intentionally lowering blood pressure, which carries risky side effects. The study focuses on patients undergoing this surgery to determine if TXA alone provides a clear view for surgeons and reduces bleeding. It targets individuals having jaw surgery at UAB Highlands Hospital who have not experienced high blood pressure or heart problems. Participants should not have bleeding disorders or medical contraindications to TXA. As a Phase 4 trial, this study involves an FDA-approved treatment and aims to understand how TXA benefits more patients undergoing jaw surgery.

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.

What is the safety track record for tranexamic acid and the avoidance of deliberate hypotensive anesthesia?

Research has shown that tranexamic acid (TXA) is generally safe for use during surgeries. Studies have found that TXA significantly reduces blood loss without increasing the risk of heart problems. For example, patients undergoing general surgery experienced less bleeding and did not face more heart issues. TXA also lowers the need for blood transfusions and reduces the likelihood of additional surgery due to bleeding. It has been widely studied and used, demonstrating good results in managing surgical bleeding without serious side effects. TXA is well-tolerated, making it a promising option for controlling bleeding in surgeries. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Tranexamic acid is unique because it specifically targets and reduces surgical bleeding by inhibiting the breakdown of blood clots. Unlike standard treatments that might involve blood transfusions or other hemostatic agents, tranexamic acid works by stabilizing clots, potentially leading to less blood loss during surgery. Researchers are excited about this treatment because it offers a targeted approach to managing bleeding, which could result in safer surgical outcomes and reduce the need for additional interventions.

What evidence suggests that tranexamic acid might be an effective treatment for surgical bleeding control?

Research has shown that tranexamic acid (TXA), which participants in this trial will receive alongside the avoidance of deliberate hypotensive anesthesia, helps reduce bleeding during surgery. One study found that TXA significantly lowered the risk of bleeding without increasing heart-related risks. Another large study found that TXA reduced major bleeding by about 25% compared to a placebo. This suggests that TXA can help control blood loss and might make some risky procedures, like deliberately lowering blood pressure during surgery, unnecessary. Overall, TXA is well-regarded for its ability to manage bleeding in various surgeries. ^{1 2 6 7 8}

Who Is on the Research Team?

Brian Kinard, DMD, MD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for individuals undergoing bimaxillary orthognathic surgery at UAB Highlands Hospital. It's not suitable for those with high blood pressure, heart issues, bleeding disorders, or who can't safely receive tranexamic acid (TXA).

Inclusion Criteria

I had jaw surgery at UAB Highlands Hospital.

Exclusion Criteria

I have a bleeding disorder.

I have a history of high blood pressure or heart issues.

I cannot take TXA due to medical reasons.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Evaluation

Patients are evaluated for variables such as sex, age, weight, preoperative hemoglobin, and preoperative hematocrit

1 day

1 visit (in-person)

Treatment

Patients undergo orthognathic surgery with administration of 1g of TXA perioperatively and limited use of deliberate hypotensive anesthesia

1 day

1 visit (in-person)

Post-operative Monitoring

Perioperative and post-operative measurements include estimated blood loss, hemoglobin, hematocrit, and mean arterial pressure

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Avoidance of Deliberate Hypotensive Anesthesia
• Tranexamic Acid

Trial Overview The study is testing if using TXA during jaw surgery can control blood loss well enough to avoid the need for deliberately lowering blood pressure—anesthesia practice that reduces bleeding but has risks like kidney and heart problems.

How Is the Trial Designed?

Group I: Patients Receiving Tranexamic Acid with Avoidance of Hypotensive Anesthesia Experimental Treatment 2 Interventions

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?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

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]

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]

Citations

1. 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 ...

2. nejm.org nejm.org/doi/full/10.1056/NEJMoa2201171

Tranexamic Acid in Patients Undergoing Noncardiac Surgery Large surgical trials have shown that tranexamic acid reduces the incidence and severity of bleeding in patients undergoing cesarean section or ...

3. bmj.com bmj.com/content/385/bmj-2024-079444

Wider use of tranexamic acid to reduce surgical bleeding ... 11 Tranexamic acid reduced major bleeding by about 25% (9% of patients v 12% with placebo). The effects were not found to vary by type of ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT01655641

Study of Tranexamic Acid for Reducing Blood Requirement ... Tranexamic acid is an antifibrinolytic agent that has been shown to be associated with reduced bleeding and transfusion requirement in surgical patients. We ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0890509625001475

Efficacy and Safety of Tranexamic Acid in Noncardiac ... TXA does not increase the risk of TEC in NCAP. However, there is currently insufficient evidence that TXA reduces bleeding complications.

6. thrombosisjournal.biomedcentral.com thrombosisjournal.biomedcentral.com/articles/10.1186/s12959-021-00303-9

Tranexamic acid for the prevention and treatment of bleeding ... The results demonstrated that TXA reduced blood loss, blood transfusion and reintervention, without increasing the risk of thrombotic ...

7. journals.lww.com journals.lww.com/plasreconsurg/fulltext/2022/03000/safety_and_efficacy_of_local_tranexamic_acid_for.49.aspx

Safety and Efficacy of Local Tranexamic Acid for the... ... Outcome data included blood loss, transfusion requirements, postoperative major bleeding requiring intervention, and surgeon satisfaction with the surgical ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7023891/

The many roles of tranexamic acid In a systematic review and meta-analysis, TXA was shown to reduce blood loss in surgical patients by nearly one-third compared to placebo. The CRASH-2 trial ...