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

94 Participants Needed

Trial Summary

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 Tranexamic Acid (TXA) generally safe for use in humans?

Tranexamic Acid (TXA) is generally considered safe for use in humans, but there are rare cases where it can cause serious side effects if accidentally injected into the spine, leading to heart and nerve problems. It has been used safely in various surgeries and for treating skin conditions like melasma, with studies showing it is well-tolerated. ^{1 2 3 4 5}

How does the drug Tranexamic Acid differ from other treatments for hip socket surgery?

Tranexamic Acid (TXA) is unique because it helps reduce bleeding during surgeries by preventing the breakdown of blood clots, which is particularly useful in orthopedic surgeries like hip socket surgery. Unlike other treatments, TXA works by blocking enzymes that dissolve clots, making it effective in managing surgical bleeding. ^{1 2 6 7 8}

What is the purpose of this trial?

This multi-center, prospective study will evaluate the use of topical tranexamic acid (TXA - Cyklokapron; Pfizer, New York, NY) on pre-operative and post-operative hemoglobin (Hb)/hematocrit (Hct) in patients undergoing operative repair of isolated posterior wall (PW) acetabular fractures.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Ventriculolumbar perfusion and inhalational anesthesia with sevoflurane in an accidental intrathecal injection of tranexamic acid: unreported treatment options. [2022]

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

Synthesis of [17,18-3H] trans-13-azaprostanoic acid. A labeled probe for the PGH2/TXA2 receptor. [2019]

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

Antiplatelet and anticoagulant effects of "HN-11 500," a selective thromboxane receptor antagonist. [2019]

4. India pubmed.ncbi.nlm.nih.gov

Oral Tranexamic Acid for the Treatment of Melasma: Evidence and Experience-Based Consensus Statement from Indian Experts. [2023]

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

MC-002 exhibits positive effects against platelets aggregation and endothelial dysfunction through thromboxane A2 inhibition. [2014]

6. England pubmed.ncbi.nlm.nih.gov

Discovery of potent, efficacious, and orally bioavailable inhibitors of blood coagulation factor Xa with neutral P1 moieties. [2014]

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

3-Substituted imidazo[1,2-d][1,2,4]-thiadiazoles: a novel class of factor XIIIa inhibitors. [2014]

8. United States 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. [2013]