283 Participants Needed

Tranexamic Acid for Hip Fracture

(TAHFT Trial)

Age: 65+
Sex: Any
Trial Phase: Phase 3
Sponsor: Lancaster General Hospital
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

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.12345

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.36789

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.2461011

Research Team

GT

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
See 1 more

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.
See 1 more

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 OverviewThe 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
2Treatment groups
Active Control
Placebo Group
Group I: InterventionActive Control1 Intervention
100 cc normal saline with 1g of tranexamic acid in solution
Group II: PlaceboPlacebo Group1 Intervention
100 cc normal saline

Find a Clinic Near You

Who Is Running the Clinical Trial?

Lancaster General Hospital

Lead Sponsor

Trials
25
Recruited
4,100+

References

Impact of Tranexamic Acid in Total Knee and Total Hip Replacement. [2017]
Meta-analysis of Intravenous Tranexamic Acid in Primary Total Hip Arthroplasty. [2018]
A systematic review of tranexamic acid in hip fracture surgery. [2022]
Errata. [2020]
Expanded use of tranexamic acid is safe and decreases transfusion rates in patients with geriatric hip fractures. [2022]
Safety and efficacy of intra-articular injection of tranexamic acid in total knee arthroplasty. [2022]
Do we really need tranexamic acid in total hip arthroplasty? A meta-analysis of nineteen randomized controlled trials. [2022]
Effectiveness of administering tranexamic acid to high-risk hip and knee arthroplasty patients: a systematic review protocol. [2021]
Update on the efficacy and safety of intravenous tranexamic acid in hip fracture surgery: a systematic review and meta-analysis. [2023]
Comparison between topical and intravenous administration of tranexamic acid in primary total hip arthroplasty. [2022]
11.United Statespubmed.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]