Hemostatic Agents for Kidney Cancer

Overseen By Arieh Shalhav, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Chicago

Must not be taking: Anticoagulants

Disqualifiers: Hemodialysis, Renal transplantation, Bleeding disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the necessity of hemostatic agents (substances that help stop bleeding) during robotic partial nephrectomy, a type of kidney cancer surgery. The goal is to determine if patients experience different complication levels with or without these agents. Suitable participants include those with a kidney tumor identified through imaging tests like an ultrasound or CT scan and who are scheduled for robotic-assisted surgery.

As an unphased trial, this study provides patients the chance to contribute to important research that could enhance surgical outcomes.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on therapeutic anticoagulation (blood thinners like aspirin 325 mg daily, clopidogrel, or warfarin), you cannot participate. However, taking a low-dose aspirin (81 mg daily) is allowed.

What prior data suggests that hemostatic agents are safe for use in robotic partial nephrectomy?

Studies have shown that hemostatic agents often control bleeding during surgeries, including kidney surgeries. These agents help blood clot quickly, reducing bleeding risk. Research indicates that patients generally tolerate hemostatic agents well. They are designed to be safe and effective in stopping bleeding.

However, some studies note that hemostatic agents can sometimes cause complications. On imaging scans, they might resemble abscesses, tumors, or other foreign objects, potentially leading to diagnostic confusion. Despite this, there is no strong evidence of severe adverse effects directly caused by the agents themselves in most cases.

Hemostatic agents have received approval for surgical use from regulatory bodies like the FDA, indicating their safety for their intended purpose. This approval means they have undergone testing and are considered safe for controlling bleeding during surgeries. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for kidney cancer focus on targeting cancer cells directly through surgery, chemotherapy, or immunotherapy. However, researchers are excited about using hemostatic agents because they offer a different approach by controlling bleeding after kidney surgery. This is vital because minimizing blood loss can lead to quicker recovery times and fewer complications, making surgery safer for patients. Unlike standard care, which often involves managing bleeding with traditional methods like cauterization or sutures, hemostatic agents work by rapidly promoting clotting at the surgical site. This innovative approach could significantly enhance surgical outcomes and improve patient safety.

What evidence suggests that this trial's treatments could be effective for kidney cancer?

Research has shown that hemostatic agents, which speed up blood clotting, are often used in urologic surgeries to help stop bleeding. These products prove helpful in surgeries like kidney tumor removal by reducing bleeding. In this trial, one group of participants will receive hemostatic agents to control bleeding more effectively during operations, while another group will use a suture-only technique. However, these agents can sometimes resemble other issues on post-surgery scans, such as tumors or abscesses. Overall, hemostatic agents serve as valuable tools in managing blood loss during surgery. ^{1 3 4 5 6}

Who Is on the Research Team?

Arieh Shalhav, MD

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

This trial is for adults with kidney tumors or cancer, who have a mass that looks like it might be malignant on an ultrasound, CT scan, or MRI. They should be scheduled for robotic-assisted laparoscopic partial nephrectomy and can have various common renal vessel configurations. People with bleeding disorders, previous kidney surgeries (except biopsy), renal transplants, or those on certain anticoagulants are not eligible.

Inclusion Criteria

My kidneys have either the usual blood vessel setup or a common variation.

My kidney tumor is suspected to be cancerous based on an ultrasound, CT, or MRI.

I have my own kidneys, whether one or two, not a transplanted one.

Exclusion Criteria

I have a bleeding disorder or liver disease with an INR over 1.0.

You have lost more than 100 milliliters of blood before the surgery starts.

I have had a kidney transplant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo robotic partial nephrectomy with or without hemostatic agents

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including changes in hemoglobin and major bleeding complications

6 months

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Hemostatic Agent
• No Hemostatic Agent

Trial Overview The study is testing the necessity of hemostatic agents in robotic partial nephrectomy for treating kidney cancer. It compares outcomes between patients undergoing surgery with and without these blood-controlling substances to see if there's a difference in complications.

How Is the Trial Designed?

Group I: Group 1 (Hemostatic Agents Plus +) Experimental Treatment 1 Intervention

Group II: Group 2 (Hemostatic Agents Negative -) Active Control 1 Intervention

No Hemostatic Agent

Hemostatic Agent is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Hemostatic Agents for:

• Surgical hemostasis
• Prevention of postoperative bleeding

Approved in European Union as Hemostatic Agents for:

• Surgical hemostasis
• Prevention of postoperative bleeding

Approved in Canada as Hemostatic Agents for:

• Surgical hemostasis
• Prevention of postoperative bleeding

Approved in Japan as Hemostatic Agents for:

• Surgical hemostasis
• Prevention of postoperative bleeding

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Published Research Related to This Trial

Fibrin sealants have been effectively used for nearly 20 years in various surgical procedures, starting from cardiac surgery, to achieve hemostasis by combining fibrinogen and thrombin at the bleeding site.

This study specifically compares the safety and effectiveness of fibrin sealants to absorbable hemostats in urologic procedures, highlighting the importance of understanding the potential adverse outcomes associated with additional components in commercial formulations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hemostasis during urologic surgery: fibrin sealant compared with absorbable hemostat. Albala, DM., Riebman, JB., Kocharian, R., et al.[2020]

The study found that combining fibrin glue with a collagen hemostatic agent resulted in the strongest adhesion to renal tissue during laparoscopic partial nephrectomies, indicating its effectiveness in promoting hemostasis.

However, the adhesive effect of fibrin glue was diminished when applied after the hemostatic agent, suggesting that the timing and order of application are crucial for maximizing its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Basic in vitro experiment on the adhesive effects of sheet-type hemostatic agents used in combination with a liquid fibrin sealant. Ishii, K., Kawashima, H., Hayama, T., et al.[2016]

The use of hemostatic agents and sealants in urologic surgery has significantly increased, reflecting advancements in surgical techniques and the need for improved patient outcomes.

This review highlights the importance of these agents in enhancing surgical management, suggesting they play a crucial role in controlling bleeding and promoting healing during urologic procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current Status of Hemostatic Agents and Sealants in Urologic Surgical Practice. Kommu, SS., McArthur, R., Emara, AM., et al.[2022]

Fibrin sealant, approved by the FDA since 1998, is the only agent recognized as a hemostat, sealant, and adhesive, and its applications in both laboratory and clinical settings are expanding rapidly, with around 200 new studies published each year.

Recent developments include new formulations and applications of fibrin sealant, which are expected to enhance its effectiveness and improve patient care in various medical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fibrin Sealant: The Only Approved Hemostat, Sealant, and Adhesive-a Laboratory and Clinical Perspective. Spotnitz, WD.[2022]

Immunotherapy using monoclonal antibodies targeting PD-1, PD-L1, and CTLA-4 has become the first-line standard treatment for patients with moderate to poor-risk metastatic renal cell carcinoma (RCC).

Combination therapies that include immune-oncology agents and anti-VEGF antibodies show promise for all risk levels, particularly in patients with high PD-L1 expression, while nivolumab is established as a second or third-line treatment option after tyrosine kinase inhibitor failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of immunotherapy in kidney cancer. Nazzani, S., Bazinet, A., Karakiewicz, PI.[2022]

A systematic review of 52 randomized studies found that surgical hemostatic agents do not significantly reduce blood transfusion rates, complications, or hospital stay durations compared to conventional hemostatic techniques.

These agents may be useful as a complementary option for managing persistent bleeding after standard methods, but their routine use in the absence of bleeding is not justified, highlighting the need for further clinical studies to assess their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical hemostatic agents: assessment of drugs and medical devices. Aubourg, R., Putzolu, J., Bouche, S., et al.[2018]

Immunotherapy has shown long-lasting benefits for patients with metastatic renal cell cancer (RCC), with some patients achieving complete responses lasting decades, particularly with older treatments like interferon-alpha and interleukin-2.

Newer therapies targeting tumor angiogenesis and metabolism, along with emerging immune checkpoint inhibitors, are expanding treatment options for RCC, prompting the Society for Immunotherapy of Cancer to develop consensus recommendations for clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Society for Immunotherapy of Cancer consensus statement on immunotherapy for the treatment of renal cell carcinoma. Rini, BI., McDermott, DF., Hammers, H., et al.[2018]

Recent advancements in understanding renal cell carcinoma (RCC) biology have led to the development of targeted therapies that inhibit angiogenesis, significantly improving treatment options for patients with advanced RCC.

Agents like sunitinib, sorafenib, temsirolimus, and bevacizumab have shown positive results in clinical studies, marking a shift in the standard of care for patients with unresectable or metastatic RCC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systemic therapy for patients with advanced, unresectable ormetastatic renal cell carcinoma: moving to guidelines. Hotte, SJ., Kapoor, AK.[2021]

Haemostatic sealants have been shown to be effective and safe for controlling bleeding during nephron-sparing surgery, based on evidence from 15 animal studies and 11 clinical reports.

These sealants, particularly synthetic or fibrin glue, are effective in laparoscopic procedures and should be used as complementary agents alongside other haemostatic techniques to enhance surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Haemostatic sealants in nephron-sparing surgery: what surgeons need to know. Dalpiaz, O., Neururer, R., Bartsch, G., et al.[2008]

Bioadhesives, tissue sealants, and hemostatic agents enhance the safety and efficacy of minimally invasive urologic surgeries by promoting clot formation and tissue adhesion through various mechanisms, including enzymatic reactions and polymerization.

These agents not only facilitate complex reconstructive procedures but also have a favorable safety profile, making them valuable tools in modern urologic surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in bioadhesives, tissue sealants, and hemostatic agents. Wheat, JC., Wolf, JS.[2022]

Radical nephrectomy is the preferred treatment for localized renal cell carcinoma, but there is a significant risk of recurrence, estimated at 30-40% after surgery.

Conservative surgery and new ablative techniques like radiofrequency and cryoablation may be viable alternatives for smaller tumors, but their long-term effectiveness is still under investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Kidney cancer management in 2007: news and recommendations]. Cornu, JN., Rouprêt, M., Lang, H., et al.[2008]

Recent advancements in the treatment of metastatic renal cell carcinoma (RCC) have led to improved clinical outcomes with agents like sunitinib, sorafenib, and bevacizumab, which work by inhibiting vascular endothelial growth factor pathways.

Ongoing clinical trials are exploring combinations and new agents targeting previously unexploited pathways, which may further enhance treatment options for metastatic RCC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel therapeutics for metastatic renal cell carcinoma. Hutson, TE., Figlin, RA.[2009]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4633658/

Current Status of Hemostatic Agents and Sealants in Urologic ... Hemostatic agents and tissue sealants are one of many options to achieve effective hemostasis and tissue sealing in urologic surgery.

2. ajronline.org ajronline.org/doi/10.2214/AJR.17.18991

Hemostatic Agents and Tissue Sealants: Potential Mimics of ... On postoperative imaging, hemostatic agents may mimic abscesses, tumors, enlarged lymph nodes, or retained foreign bodies.

3. eajm.org eajm.org/content/files/sayilar/213/buyuk/160-164.pdf

The Use of Three Different Hemostatic Agents during ... A wide variety of hemostatic agents have been developed to reduce the hemorrhage following the excision of the kidney tumor during PN. [14]. These agents are ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022534706019550

The Use of Hemostatic Agents and Sealants in Urology For FDA regulation hemostatic agents are defined as a device intended to produce hemostasis by accelerating the clotting process of blood. Broadly these agents ...

5. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/000313481207801221

Article Commentary: Hemostats, Sealants, and Adhesives Hemostats, sealants, and adhesives are useful adjuncts to modern surgical procedures. To maximize their benefit, a surgeon needs to ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3960746/

Fibrin Sealant: The Only Approved Hemostat, Sealant, and ... Both sealants and adhesives when applied to potentially leaking blood vessels may have a hemostatic effect by blocking holes in the vessel and preventing ...