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

50 Participants Needed

Trial Summary

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 data supports the effectiveness of the drug Tranexamic Acid for surgical bleeding control?

Tranexamic Acid (TXA) has been shown to reduce blood loss during surgery and decrease the need for blood transfusions, as well as reduce mortality in trauma and childbirth cases. It is effective in minimizing bleeding in various surgeries, including shoulder and abdominal surgeries. ^{1 2 3 4 5}

Is tranexamic acid (TXA) safe for use in humans?

Tranexamic acid (TXA) is generally considered safe for reducing bleeding in surgeries and trauma, with studies showing it decreases mortality and blood loss. However, there are concerns about potential thrombotic events (blood clots) and seizures, so its safety in these areas is still being studied. ^{1 3 6 7 8}

How is the drug Tranexamic Acid different from other treatments for surgical bleeding control?

Tranexamic Acid (TXA) is unique because it prevents the breakdown of blood clots rather than forming new ones, making it effective in controlling bleeding during surgery and trauma. It has been safely used worldwide since the 1960s and is notable for its stability across a wide range of temperatures, which is beneficial for use in various settings, including prehospital and military environments. ^{4 9 10 11 12}

What is the purpose of this trial?

This prospective study will analyze the need for deliberate hypotensive anesthesia (DHA) during orthognathic surgery when tranexamic acid (TXA) is administered. DHA has been proven to be effective although it comes with multiple risks related to organ hypoperfusion including kidney injury, stroke, and cardiac ischemia. Therefore, it may be potentially safer for patients to avoid deliberate hypotensive anesthesia if TXA alone adequately controls blood loss and provides adequate surgical site visualization.

Research Team

Brian Kinard, DMD, MD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Tranexamic acid administration for anatomic and reverse total shoulder arthroplasty: a systematic review and meta-analysis. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of tranexamic acid in minimizing perioperative bleeding in extrahepatic abdominal surgery: meta-analysis. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Effect of tranexamic acid on thrombotic events and seizures in bleeding patients: a systematic review and meta-analysis. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Stability of tranexamic acid after 12-week storage at temperatures from -20°c to 50°c. [2014]

5. United Arab Emirates 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. [2022]

6. 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]

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

Role of Tranexamic Acid in the Clinical Setting. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Effects of tranexamic acid on short-term and long-term outcomes of on-pump coronary artery bypass grafting: Randomized trial and 7-year follow-up. [2019]

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

The impact of prehospital TXA on mortality among bleeding trauma patients: A systematic review and meta-analysis. [2023]

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

The Efficacy and Safety of Tranexamic Acid Treatment in Orthopaedic Trauma Surgery. [2023]

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

Tranexamic acid and perioperative bleeding in children: what do we still need to know? [2019]

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

Tranexamic acid for trauma patients: a critical review of the literature. [2013]