Tranexamic Acid for Surgery on Long Bone Fractures

(TXA Trial)

YV
MM
Overseen ByMolly Mounsey, MD
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Arbi Nazarian, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the use of tranexamic acid (TXA) to reduce blood loss during surgeries for long bone fractures. TXA already reduces blood loss and lowers hospital costs in hip and knee surgeries without increasing risk. The trial aims to determine if TXA offers similar benefits for other bone surgeries, particularly for patients on blood thinners. It may be suitable for surgeries involving specific leg fractures, such as a broken femur or tibia. Participants will either receive TXA or not, allowing researchers to compare outcomes. As a Phase 4 trial, TXA is already FDA-approved and proven effective, and this research seeks to understand how it benefits more patients.

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 (TXA)?

Research has shown that tranexamic acid (TXA) is generally safe for use in surgeries for broken bones, helping to reduce blood loss during these operations. One study found that TXA lowered the need for a blood transfusion without increasing the risk of blood clots. Another study demonstrated that TXA safely reduced hidden blood loss in certain hip fracture surgeries. Overall, TXA is widely used in surgeries and is well-tolerated by patients. It has proven effective and safe in reducing blood loss across various types of surgeries.12345

Why are researchers enthusiastic about this study treatment?

Unlike the standard of care for long bone fracture surgeries, which often includes blood transfusions and various anti-inflammatory medications, tranexamic acid (TXA) stands out because of its ability to reduce bleeding by stabilizing blood clots. Most treatments for this condition focus on managing pain and inflammation, but TXA specifically targets the body's fibrinolytic system to prevent excessive blood loss during surgery. Researchers are excited about TXA because it has the potential to decrease the need for blood transfusions, reduce surgical complications, and speed up recovery times, making surgeries safer and more efficient for patients.

What is the effectiveness track record for Tranexamic Acid in reducing blood loss during surgery?

Studies have shown that tranexamic acid (TXA) reduces blood loss during orthopedic surgeries, such as hip and knee replacements. Research indicates that TXA lowers the need for blood transfusions without increasing the risk of blood clots. In patients with bone injuries, TXA has reduced hidden blood loss, which is not immediately visible. Another study found that patients who received TXA had lower death rates compared to those who did not. In this trial, some participants will receive TXA to assess its effectiveness in controlling blood loss during surgeries for long bone fractures, while others will not receive TXA for comparison.12345

Who Is on the Research Team?

AN

Arbi Nazarian, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for patients undergoing surgery for long bone fractures. It's exploring if Tranexamic Acid (TXA), a medication that reduces blood loss, can be beneficial in orthopedic trauma cases. The study aims to improve patient outcomes and reduce costs.

Inclusion Criteria

I am having surgery for a major bone fracture.

Exclusion Criteria

I am under 18 years old.
Prisoners

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive tranexamic acid or no intervention during orthopedic trauma procedures

Immediate post-procedure

Follow-up

Participants are monitored for estimated blood loss and hospital length of stay post-procedure

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Tranexamic Acid (TXA)
Trial Overview The study tests the effectiveness of TXA in reducing blood loss during orthopedic surgeries for fracture repair. Researchers want to see if it works as well in trauma cases as it does in hip and knee replacements, without increasing thrombotic risks.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Yes TXA AdministeredExperimental Treatment1 Intervention
Group II: No TXA AdministeredActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Arbi Nazarian, MD

Lead Sponsor

Inspire Health Medical Group

Collaborator

Citations

Tranexamic Acid in Orthopaedic Trauma Surgery: A meta- ...In orthopaedic trauma patients, TXA reduces the risk of blood transfusion, reduces perioperative blood loss, and has no significant effect on the risk of ...
Efficacy and safety of tranexamic acid for patients with ...Tranexamic acid safely reduces hidden blood loss in patients undergoing intertrochanteric fracture surgery: A randomized controlled trial.
Use of tranexamic acid in trauma surgical specialtiesThe author concluded that mortality at 24 h was lower among patients receiving TXA compared to placebo (9.7% vs. 14.1%, RR = 0.69, 95% CI 0.51– ...
Study Of Tranexamic Acid For The Reduction Of Blood ...This study would aim to see the effect of tranexamic acid in reduction of blood loss and transfusions for long bone fracture surgery, primarily fracture shaft ...
Evaluation of the efficacy of perioperative tranexamic acid .. ...Conclusion: TXA did not demonstrate a significant benefit in reducing perioperative bleeding or complications in patients treated with ORIF for ...
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