What side effects are associated with this type of intervention?

Tranexamic acid (TXA), used to prevent excessive bleeding in hip fracture treatments, can cause thromboembolic complications such as stroke, deep vein thrombosis, and pulmonary embolism, particularly in patients with a history of these conditions. There is also a dose-related risk of seizures, especially in patients with renal dysfunction, lower body weight, or malnutrition. Other common treatments like anticoagulants (e.g., enoxaparin, rivaroxaban) may lead to bleeding complications and, in some cases, an increased risk of thromboembolic events.

What prior FDA approvals exist?

The FDA has approved several treatments for hip fractures, particularly focusing on anticoagulants and antifibrinolytic agents. Tranexamic acid, an antifibrinolytic agent, is used to reduce perioperative blood loss and the need for transfusions in surgeries, including hip fracture repairs. Enoxaparin, a low molecular weight heparin, is another FDA-approved drug used to prevent venous thromboembolism in patients undergoing hip fracture surgery. These treatments aim to manage bleeding and clotting complications associated with hip fractures and their surgical repair.

What other types of research exist?

As of 2024, promising novel alternatives to Tranexamic Acid for hip fracture patients may include newer antifibrinolytic agents, advanced hemostatic drugs, or innovative surgical techniques designed to minimize bleeding. Specific alternatives are not detailed in the provided context, but ongoing research and clinical trials are likely exploring these options.

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Tranexamic Acid for Hip Fracture (TAHFT Trial)

Phase 3

Waitlist Available

Led By Gregory Tocks, DO

Research Sponsored by Lancaster General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Hip fracture location within the femoral neck, intertrochanteric, and subtrochanteric regions

Indication for one of the following surgical interventions: hemiarthroplasty, total hip replacement, sliding plate and screw fixation, or intramedullary fixation

Must not have

Indication for closed reduction or percutaneous screw

Presence of hypercoaguable disorder, including cancer (active disease), elevated blood homocysteine levels, antiphospholipid antibody syndrome and inherited protein deficiencies (antithrombin III, factor V Leiden, protein S & C deficiencies, prothrombin gene mutation)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of study intervention/surgery for hip fracture until the date of discharge or date of death from any cause, whichever came first, assessed up to 34 months.

Awards & highlights

All Individual Drugs Already Approved

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Tranexamic Acid can cause side effects such as nausea, vomiting, diarrhea, and possibly increase the risk of blood clots. However, it's generally well-tolerated when used to reduce bleeding during surgeries.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am indicated for a specific type of hip surgery.

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I am 65 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I need a procedure to fix a bone with minimal surgery.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of study intervention/surgery for hip fracture until the date of discharge or date of death from any cause, whichever came first, assessed up to 34 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of study intervention/surgery for hip fracture until the date of discharge or date of death from any cause, whichever came first, assessed up to 34 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of study intervention/surgery for hip fracture until the date of discharge or date of death from any cause, whichever came first, assessed up to 34 months. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Count of Participants With Acute Post-operative Transfusion of Packed Red Blood Cells.

Secondary study objectives

Complication Rate

Hospital Readmission

Length of Stay

+1 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Tranexamic acid, an antifibrinolytic agent, inhibits the conversion of plasminogen to plasmin, thereby preventing the breakdown of fibrin clots. This mechanism is crucial for hip fracture patients as it helps to stabilize blood clots, reduce perioperative blood loss, and minimize the need for blood transfusions. This can lead to fewer complications and better surgical outcomes, which is particularly beneficial for the often vulnerable hip fracture patient population.

[Application of tranexamic acid in the treatment of intertrochanteric fracture of femur].