Perivascular Dexamethasone for Deep Vein Thrombosis

(DEXTERITY-AFP Trial)

Recruiting at 17 trial locations

Overseen By Kirk Seward, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Mercator MedSystems, Inc.

Must be taking: Anticoagulants, Antiplatelets

Disqualifiers: Pulmonary embolism, Severe renal impairment, others

No Placebo Group

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial uses a special tool to deliver an anti-inflammatory medicine directly to deep veins in patients who recently had a vein-clearing procedure for DVT. The goal is to reduce inflammation, prevent re-blockage, and improve symptoms over time.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you will need to take certain medications like low molecular weight heparin and possibly an antiplatelet agent as part of the study.

Is dexamethasone generally safe for humans?

Dexamethasone is generally well tolerated in humans, but it can cause some side effects like increased eye pressure and cataracts when used in eye treatments. It is also used safely in surgeries to reduce pain and nausea, though there are concerns about its effects on the immune system and blood sugar levels. ^{1 2 3 4 5}

How does perivascular dexamethasone differ from other treatments for deep vein thrombosis?

Perivascular dexamethasone is unique because it involves administering the drug around blood vessels, which may target inflammation directly at the site of a deep vein thrombosis (a blood clot in a deep vein). This method is different from standard treatments that typically involve blood thinners taken orally or by injection to prevent clot growth and reduce the risk of further clots. ^{6 7 8 9 10}

Eligibility Criteria

Adults aged 18-89 with recent deep vein thrombosis (DVT) in the leg, who can take oral medication and agree to long-term anticoagulant therapy. They must not be enrolled in other drug/device trials, have a BMI over 45, severe health conditions that affect study participation or outcomes, known allergies to drugs used in the trial, or be pregnant/breastfeeding.

Inclusion Criteria

I can take pills and will follow the blood thinner plan.

For females of reproductive potential: use of highly effective contraception (abstinence is acceptable) for at least 1 month prior to study treatment (unless they had given birth within the 1 month prior to study treatment), and agreement to use such a method for at least 30 days after study treatment

I will be on a blood thinner for at least 13 months after my procedure.

Exclusion Criteria

You have had a stent placed in a vein on the same side of your body.

I have not had a bleeding stroke in the past year.

I have not had eye surgery or a bleeding eye condition in the last 3 months.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive local delivery of dexamethasone sodium phosphate injection around the deep veins after DVT recanalization using the Bullfrog® Micro-Infusion Device

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of PTS rate and primary patency

6 months

Multiple visits (in-person and virtual)

Long-term follow-up

Participants are monitored for long-term outcomes and symptom improvement

24 months

Treatment Details

Interventions

• Dexamethasone (Corticosteroid)

Trial Overview The trial is testing if injecting dexamethasone directly around veins after DVT removal reduces re-thrombosis and improves symptoms for up to two years. Participants will receive either this treatment or a sham procedure using the Bullfrog® Micro-Infusion Device.

Participant Groups

Group I: Treatment Experimental Treatment 1 Intervention

Group II: Control Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Mercator MedSystems, Inc.

Lead Sponsor

Trials

10

Recruited

1,100+

Sentara Norfolk General Hospital

Collaborator

Trials

12

Recruited

890+

Guy's and St Thomas' NHS Foundation Trust

Collaborator

Trials

399

Recruited

1,004,000+

Memorial Hermann Hospital

Collaborator

Trials

17

Recruited

56,300+

St. John Health System, Oklahoma

Collaborator

Trials

3

Recruited

240+

Stony Brook University

Collaborator

Trials

225

Recruited

41,700+

Charlotte-Mecklenburg Hospital

Collaborator

Trials

2

Recruited

140+

Northwestern University

Collaborator

Trials

1,674

Recruited

989,000+

Medstar Health Research Institute

Collaborator

Trials

202

Recruited

187,000+

Vascular Care Connecticut

Collaborator

Trials

2

Recruited

140+

Findings from Research

In a study of 108 patients undergoing total knee arthroplasty, administering two doses of low-dose dexamethasone significantly reduced inflammatory markers (CRP and IL-6) and provided better pain relief compared to a placebo, particularly at 24 hours post-surgery.

Dexamethasone also decreased the incidence of postoperative nausea and vomiting (PONV) and postoperative fatigue, while showing no increase in the risk of surgical complications, indicating it is both effective and safe for enhancing recovery after knee surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two doses of low-dose perioperative dexamethasone improve the clinical outcome after total knee arthroplasty: a randomized controlled study. Xu, B., Ma, J., Huang, Q., et al.[2018]

In a study involving four patients with high intraocular pressure (IOP) responses to dexamethasone implants, the use of a XEN gel stent effectively normalized IOP, allowing continued treatment with dexamethasone, which was crucial for these patients.

After the XEN surgery, no further increases in IOP were observed following subsequent dexamethasone injections, suggesting that the XEN gel stent is a safe and effective option for managing steroid-induced ocular hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

XEN Gel Stent to Treat Intraocular Hypertension After Dexamethasone-Implant Intravitreal Injections: 5 Cases. Rezkallah, A., Mathis, T., Denis, P., et al.[2020]

A study involving 10,482 patients (137 receiving intravitreal dexamethasone and 10,345 receiving anti-VEGF) found that both treatments had similar risks for major systemic adverse events, indicating comparable safety profiles.

Both intravitreal dexamethasone and anti-VEGF medications were effective for treating ocular diseases, with no significant differences in systemic health markers or the need for glaucoma surgery between the two groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systemic Outcomes of Intravitreal Injections of Dexamethasone and Anti-Vascular Endothelial Growth Factor. Lin, TY., Hsieh, YT., Garg, SJ., et al.[2023]

In a study of 61 eyes treated with intravitreal dexamethasone implants for macular edema, 12% experienced elevated intraocular pressure (IOP) above 25 mmHg, particularly in patients with central retinal vein occlusion and glaucoma, indicating a need for careful monitoring in these subgroups.

The incidence of cataract surgery was notably high at 24% among treated phakic eyes, with the likelihood increasing with the number of implants, suggesting that repeated treatments may lead to a higher risk of cataract formation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

OBSERVED COMPLICATIONS FROM DEXAMETHASONE INTRAVITREAL IMPLANT FOR THE TREATMENT OF MACULAR EDEMA IN RETINAL VEIN OCCLUSION OVER 3 TREATMENT ROUNDS. Reid, GA., Sahota, DS., Sarhan, M.[2015]

In a study involving 73 patients undergoing percutaneous epidural adhesiolysis, dexamethasone sodium phosphate (DSP) demonstrated non-inferiority to triamcinolone acetate (TA) in reducing pain and improving function at the 6-month follow-up, with success rates of 62.5% for DSP compared to 45.2% for TA.

At 3 months, while DSP showed a higher mean percent decrease in pain scores (46.1%) compared to TA (42.4%), non-inferiority was not established until the 6-month mark, indicating that DSP may provide longer-lasting benefits in pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous Epidural Adhesiolysis with Epidural Steroid Injection: A Non-inferiority Test of Non-particulate Steroids Versus Particulate Steroids. Cho, S., Park, HS.[2018]

In a study of 102 patients undergoing total knee arthroplasty, triamcinolone acetonide provided significantly better pain relief compared to dexamethasone, with lower pain scores at rest and during walking postoperatively.

Triamcinolone also resulted in lower C-reactive protein levels, indicating reduced inflammation, while both corticosteroids similarly increased fasting blood glucose levels without significant differences in postoperative nausea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The comparison of dexamethasone and triamcinolone periarticular administration in total knee arthroplasty: retrospective cohort study. Oshima, A., Hatayama, K., Terauchi, M., et al.[2022]

In a study of 68 patients undergoing infraclavicular brachial plexus block, perineural dexamethasone significantly prolonged the duration of both motor block and analgesia compared to intravenous dexamethasone, with durations of 1768.13 minutes and 1743.59 minutes respectively versus 1245.94 minutes and 1310.16 minutes for the IV group (P < 0.001).

Patients receiving perineural dexamethasone experienced lower pain intensity and reduced need for rescue analgesia postoperatively, with only 9% reporting a Visual Analog Scale score of ≥3 compared to 37% in the intravenous group (P = 0.008).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Perineural and Intravenous Dexamethasone as an Adjuvant to Levobupivacaine in Ultrasound-Guided Infraclavicular Brachial Plexus Block: A prospective Randomized Trial. Veena, G., Pangotra, A., Kumar, S., et al.[2022]

In a study of 35 eyes with retinal vein occlusion treated with an intravitreal dexamethasone implant, the ischaemic index remained stable over 6 months, indicating that dexamethasone treatment did not significantly change peripheral nonperfusion status.

Despite the stable ischaemic index, patients experienced improvements in best-corrected visual acuity and reductions in central retinal thickness, suggesting that dexamethasone is effective in improving visual outcomes even when peripheral perfusion status does not change.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extension of peripheral nonperfusion in eyes with retinal vein occlusion during intravitreal dexamethasone treatment. Rezar-Dreindl, S., Eibenberger, K., Buehl, W., et al.[2018]

Both perineural and intravenous dexamethasone effectively prolong the duration of analgesia in supraclavicular blocks, with no significant difference in duration (817.2 min vs. 858.0 min).

Perineural dexamethasone leads to a faster onset of both sensory (10.20 min vs. 11.60 min) and motor block (13.92 min vs. 14.96 min) compared to intravenous dexamethasone, making it a potentially more effective option for quicker pain relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Perineural and Intravenous Dexamethasone on Duration of Analgesia in Supraclavicular Brachial Plexus Block with Bupivacaine: A Comparative Study. Mathew, R., Radha, KR., Hema, VR.[2022]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Two doses of low-dose perioperative dexamethasone improve the clinical outcome after total knee arthroplasty: a randomized controlled study. [2018]

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

XEN Gel Stent to Treat Intraocular Hypertension After Dexamethasone-Implant Intravitreal Injections: 5 Cases. [2020]

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

Systemic Outcomes of Intravitreal Injections of Dexamethasone and Anti-Vascular Endothelial Growth Factor. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

Infection safety of dexamethasone in total hip and total knee arthroplasty: a study of eighteen thousand, eight hundred and seventy two operations. [2020]

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

OBSERVED COMPLICATIONS FROM DEXAMETHASONE INTRAVITREAL IMPLANT FOR THE TREATMENT OF MACULAR EDEMA IN RETINAL VEIN OCCLUSION OVER 3 TREATMENT ROUNDS. [2015]

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

Percutaneous Epidural Adhesiolysis with Epidural Steroid Injection: A Non-inferiority Test of Non-particulate Steroids Versus Particulate Steroids. [2018]

7. England pubmed.ncbi.nlm.nih.gov

The comparison of dexamethasone and triamcinolone periarticular administration in total knee arthroplasty: retrospective cohort study. [2022]

8. India pubmed.ncbi.nlm.nih.gov

Comparison of Perineural and Intravenous Dexamethasone as an Adjuvant to Levobupivacaine in Ultrasound-Guided Infraclavicular Brachial Plexus Block: A prospective Randomized Trial. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Extension of peripheral nonperfusion in eyes with retinal vein occlusion during intravitreal dexamethasone treatment. [2018]

10. India pubmed.ncbi.nlm.nih.gov

Effect of Perineural and Intravenous Dexamethasone on Duration of Analgesia in Supraclavicular Brachial Plexus Block with Bupivacaine: A Comparative Study. [2022]