Tranexamic Acid for Hip Socket Surgery

Overseen By Michael Archdeacon, MD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Cincinnati

Disqualifiers: Polytrauma, Thromboembolic disease, Bleeding disorder, others

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether tranexamic acid, a medication that reduces bleeding, can improve blood levels before and after hip socket surgery. It compares the effects of applying this treatment directly to the surgical area against not using any topical treatment. The trial seeks participants with a specific type of hip fracture, known as a posterior wall acetabular fracture, who are scheduled for surgery within a week of the injury. As an Early Phase 1 trial, this research aims to understand how the treatment works in people, offering participants a chance to contribute to groundbreaking medical knowledge.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that tranexamic acid (TXA) is usually safe for surgeries like hip replacements. In studies, patients who used TXA required fewer blood transfusions, indicating less blood loss during surgery. Importantly, TXA did not increase the risk of blood clots or other serious issues. Although this trial focuses on a slightly different surgery, these findings suggest that TXA is safe for similar procedures. However, as this trial is just beginning, more information is needed to confirm its safety for hip socket surgery specifically. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for hip socket surgery, which often rely on managing bleeding through general techniques or medications, Tranexamic Acid (TXA) offers a targeted approach. TXA works by preventing excessive blood loss by stabilizing blood clots, which can be particularly beneficial in surgeries where bleeding is a concern. Researchers are excited about TXA because it's applied topically at the surgical site, potentially reducing side effects associated with systemic administration and allowing for more precise control over bleeding. This localized delivery could make recovery smoother and faster for patients.

What evidence suggests that tranexamic acid might be an effective treatment for acetabular fractures?

Research has shown that tranexamic acid (TXA) reduces blood loss during and after hip surgeries. Studies have found that TXA use in total hip and knee surgeries decreases the need for blood transfusions, indicating less overall blood loss. In this trial, participants will join different treatment arms, with some receiving topical TXA treatment. TXA prevents blood clots from breaking down too quickly, helping to control bleeding. This could benefit patients with hip socket fractures by reducing blood loss during surgery. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults with isolated, closed posterior wall acetabular fractures needing surgery within a week of injury. It's not for those with multiple injuries requiring several surgeries, pre-existing blood clots, bleeding disorders, kidney issues, or who can't consent.

Inclusion Criteria

I have a non-operative fracture in my arm that doesn't affect my ability to bear weight.

I had surgery for a specific hip fracture within a week of the injury.

My bones have stopped growing.

Exclusion Criteria

I was admitted for injuries to internal organs from a severe accident.

I had a blood clot before my surgery.

I need several surgeries.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative

Pre-operative hemoglobin and hematocrit levels are drawn to establish baseline levels

1 day

1 visit (in-person)

Treatment

Participants undergo surgery with either topical TXA or placebo applied; intraoperative transfusion requirements and estimated blood loss are recorded

1 day

1 visit (in-person)

Post-operative Monitoring

Hemoglobin and hematocrit values are obtained on postoperative day one and two; post-operative transfusion requirements are recorded

2 days

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including standard DVT prophylaxis for four weeks post-operatively

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Tranexamic Acid

Trial Overview The study tests if applying tranexamic acid (TXA) directly to the fracture site before and after surgery affects hemoglobin/hematocrit levels compared to using normal saline in patients with specific hip fractures.

How Is the Trial Designed?

Group I: Topical TXA Treatment Experimental Treatment 1 Intervention

2 gm TXA/100 ml of normal saline

Group II: No Topical Treatment Placebo Group 1 Intervention

Normal saline

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 Cincinnati

Lead Sponsor

Trials

442

Recruited

639,000+

Foundation for Orthopedic Trauma

Collaborator

Trials

2

Recruited

130+

Published Research Related to This Trial

In a phase I study involving 16 healthy male volunteers, the thromboxane receptor antagonist HN-11 500 demonstrated a significant and dose-dependent inhibition of platelet aggregation and adhesion, lasting up to 8 hours at higher doses.

HN-11 500 was well tolerated across all doses, with only a slight increase in bleeding time that remained within normal limits, indicating its potential safety as an antiplatelet agent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antiplatelet and anticoagulant effects of "HN-11 500," a selective thromboxane receptor antagonist. Schenk, JF., Radziwon, P., Fellier, H., et al.[2019]

MC-002 effectively inhibits platelet aggregation and vasoconstriction induced by thromboxane A2 (TXA2), demonstrating its potential as a therapeutic agent in stroke treatment.

The compound also protects endothelial cells from damage caused by tumor necrosis factor-alpha (TNF-α) by reducing inflammatory markers and improving nitric oxide availability, indicating a dual mechanism of action through TXA2 inhibition and NF-κB signaling pathway modulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MC-002 exhibits positive effects against platelets aggregation and endothelial dysfunction through thromboxane A2 inhibition. Fang, W., Wei, J., Han, D., et al.[2014]

A new class of selective FXIIIa inhibitors, specifically compound 8, effectively reduces fibrin cross-linking and inhibits clot formation in human plasma, demonstrating a 50% reduction at a concentration of 160 µM.

The effectiveness of compound 8 in promoting fibrinolysis is dose-dependent, meaning higher concentrations lead to faster breakdown of clots when treated with tissue plasminogen activator.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

3-Substituted imidazo[1,2-d][1,2,4]-thiadiazoles: a novel class of factor XIIIa inhibitors. Leung-Toung, R., Tam, TF., Wodzinska, JM., et al.[2014]

Tranexamic acid (TXA) has shown promising efficacy and tolerability in treating melasma, a challenging skin condition, based on evidence from multiple clinical studies.

TXA can be used alone or alongside other treatments, but there is currently no established consensus or guidelines for its use in melasma, highlighting the need for standardized treatment protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral Tranexamic Acid for the Treatment of Melasma: Evidence and Experience-Based Consensus Statement from Indian Experts. Godse, K., Sarkar, R., Mysore, V., et al.[2023]

The newly developed compound 6d demonstrates subnanomolar binding affinity for blood coagulation factor Xa, indicating its potential as a highly effective anticoagulant.

Compound 6d shows promising in vivo efficacy and oral bioavailability, making it a strong candidate for further pre-clinical evaluations in the development of anticoagulant therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Discovery of potent, efficacious, and orally bioavailable inhibitors of blood coagulation factor Xa with neutral P1 moieties. Pinto, DJ., Galemmo, RA., Quan, ML., et al.[2014]

In a case of accidental intrathecal injection of tranexamic acid (TXA) during hip surgery, the patient experienced severe neurological and cardiac complications, highlighting the potential dangers of this medication when misadministered.

The treatment involving ventriculolumbar perfusion with saline and inhalational sedation with sevoflurane showed promise in managing TXA-induced neurotoxicity, suggesting a potential approach for similar cases, although complete recovery was not achieved.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ventriculolumbar perfusion and inhalational anesthesia with sevoflurane in an accidental intrathecal injection of tranexamic acid: unreported treatment options. Godec, S., Gradisek, MJ., Mirkovic, T., et al.[2022]

The stable TXA2/PGH2 antagonist, trans-13-azaprostanoic acid (trans-13-APA), was successfully synthesized and tritiated to study its receptor and mechanism of action, providing a new tool for understanding TXA2 signaling in platelets.

The introduction of a double bond in the 17 position of platelet prostaglandin antagonists did not enhance their ability to inhibit human platelet aggregation, indicating that structural modifications may not improve antiplatelet efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Synthesis of [17,18-3H] trans-13-azaprostanoic acid. A labeled probe for the PGH2/TXA2 receptor. Ghali, NI., Kattelman, EJ., Hung, SC., et al.[2019]

2NTX-99 is a new compound that effectively inhibits thromboxane A(2) production and enhances nitric oxide availability, leading to significant relaxation of blood vessels and reduced platelet aggregation in various experimental models, including rabbit aorta and human platelet-rich plasma.

In animal studies, oral administration of 2NTX-99 resulted in a substantial reduction of thromboxane A(2) levels in rat blood, demonstrating a strong correlation between plasma concentration and TXA(2) inhibition, indicating its potential as a therapeutic agent for controlling platelet function and improving vascular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacological characterization of 2NTX-99 [4-methoxy-N1-(4-trans-nitrooxycyclohexyl)-N3-(3-pyridinylmethyl)-1,3-benzenedicarboxamide], a potential antiatherothrombotic agent with antithromboxane and nitric oxide donor activity in platelet and vascular preparations. Buccellati, C., Sala, A., Rossoni, G., et al.[2013]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9195556/

Effectiveness of using tranexamic acid in total hip and ... Tranexamic acid use in TKA and THA is effective in reducing post-operative blood loss in terms of drop in Hg level, total drainage output and blood transfusion ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2949705125000179

Tranexamic acid in total hip arthroplasty Peri-operative use of TXA in THA significantly reduced the need for blood transfusions without increasing the risk of PE or death.

3. bmj.com bmj.com/content/349/bmj.g4829

Tranexamic acid use and postoperative outcomes in ... Objective To determine the effectiveness and safety of perioperative tranexamic acid use in patients undergoing total hip or knee arthroplasty ...

4. aaos.org aaos.org/globalassets/quality-and-practice-resources/external-quality-products/aahks-transexamic-acid-final.pdf

Tranexamic Acid in Total Joint Arthroplasty Tranexamic acid (TXA) is an antifibrinolytic agent that has fundamentally changed blood management in total joint arthroplasty (TJA) by making transfusion an ...

5. bjanaesthesia.org.uk bjanaesthesia.org.uk/article/S0007-0912(22)00635-3/fulltext

Effectiveness of oral versus intravenous tranexamic acid in ... Tranexamic acid (TXA) reduces rates of blood transfusion for total hip arthroplasty (THA) and total knee arthroplasty (TKA).

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12282735/

Safety and efficacy of tranexamic acid in hip hemiarthroplasty Internal fixation reduces operational time, blood loss, infection risk, and has better peri-operative advantage, whereas hemiarthroplasty ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37563702/

and double-dose intravenous tranexamic acid in hip ... Efficacy and safety of single- and double-dose intravenous tranexamic acid in hip and knee arthroplasty: a systematic review and meta-analysis.

8. orthopedicreviews.openmedicalpublishing.org orthopedicreviews.openmedicalpublishing.org/article/118441

Evaluation of efficacy and safety of perioperative ... To this end, this study aims to assess the effectiveness of tranexamic acid (TXA) in decreasing blood loss following primary TKA. Materials and ...