Tranexamic Acid for Hip Fracture

(TAHFT Trial)

Age: 65+

Sex: Any

Trial Phase: Phase 3

Sponsor: Lancaster General Hospital

Disqualifiers: Stroke, Coronary disease, DVT, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: 1

Duration: Immediate pre-surgery

283 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing whether giving tranexamic acid (a medicine that helps blood clot) to older patients with hip fractures can reduce the need for blood transfusions. These patients often have other health problems and are at high risk of losing a lot of blood during surgery. By reducing bleeding, the medicine could help avoid complications from blood transfusions. Tranexamic acid (TXA) has been widely used to decrease blood loss and transfusion rates in various orthopedic surgeries, including hip fractures.

Will I have to stop taking my current medications?

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 hip fracture?

Research shows that tranexamic acid helps reduce blood loss and the need for blood transfusions in hip fracture surgeries, making it effective in managing bleeding during these procedures. ^{1 2 3 4 5}

Is tranexamic acid safe for use in humans?

Research shows that tranexamic acid has been studied for safety in surgeries like knee and hip replacements, and while it helps reduce blood loss, no single study has been large enough to definitively confirm its safety. However, the existing studies suggest it is generally safe when used in these contexts. ^{3 6 7 8 9}

How does the drug tranexamic acid differ from other treatments for hip fracture?

Tranexamic acid is unique because it is used to reduce blood loss during surgery by preventing the breakdown of blood clots, and it can be administered in various ways, such as intravenously or topically, to target the bleeding site directly. This approach is different from other treatments that may not focus specifically on controlling surgical bleeding. ^{2 4 6 10 11}

Research Team

Gregory Tocks, DO

Principal Investigator

Penn Medicine / Lancaster General Hospital

Eligibility Criteria

This trial is for people aged 65 or older who have a hip fracture in specific areas and need surgery like hemiarthroplasty, total hip replacement, or certain types of fixation. It's not for those with clotting disorders, recent strokes, heart attacks, deep vein thrombosis/pulmonary emboli, or allergies to Tranexamic Acid.

Inclusion Criteria

I am 65 years old or older.

My hip fracture is in the upper part of my thigh bone.

Provision of written informed consent

Exclusion Criteria

I haven't had a stroke, heart attack, or blood clots in the past month.

I have a condition that makes my blood clot more easily.

You are allergic to TXA.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intravenous tranexamic acid or placebo prior to hip fracture surgery

Immediate pre-surgery

1 visit (in-person)

Post-operative Monitoring

Participants are monitored for acute post-operative transfusions and complications

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including complications and mortality

3 months

Treatment Details

Interventions

• Placebo
• Tranexamic Acid Injectable Solution

Trial Overview The study tests if giving Tranexamic Acid (TXA) before surgery helps geriatric patients with hip fractures compared to a placebo. Participants are randomly assigned to receive either TXA or placebo without knowing which one they get.

Participant Groups

Group I: Intervention Active Control 1 Intervention

100 cc normal saline with 1g of tranexamic acid in solution

Group II: Placebo Placebo Group 1 Intervention

100 cc normal saline

Who Is Running the Clinical Trial?

Lancaster General Hospital

Lead Sponsor

Trials

25

Recruited

4,100+

References

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

Impact of Tranexamic Acid in Total Knee and Total Hip Replacement. [2017]

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

Meta-analysis of Intravenous Tranexamic Acid in Primary Total Hip Arthroplasty. [2018]

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

A systematic review of tranexamic acid in hip fracture surgery. [2022]

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

Errata. [2020]

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

Expanded use of tranexamic acid is safe and decreases transfusion rates in patients with geriatric hip fractures. [2022]

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

Safety and efficacy of intra-articular injection of tranexamic acid in total knee arthroplasty. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Do we really need tranexamic acid in total hip arthroplasty? A meta-analysis of nineteen randomized controlled trials. [2022]

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

Effectiveness of administering tranexamic acid to high-risk hip and knee arthroplasty patients: a systematic review protocol. [2021]

9. France pubmed.ncbi.nlm.nih.gov

Update on the efficacy and safety of intravenous tranexamic acid in hip fracture surgery: a systematic review and meta-analysis. [2023]

10. Japan pubmed.ncbi.nlm.nih.gov

Comparison between topical and intravenous administration of tranexamic acid in primary total hip arthroplasty. [2022]

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

Topical (intra-articular) tranexamic acid reduces blood loss and transfusion rates following total hip replacement: a randomized controlled trial (TRANX-H). [2022]