Hemostatic Agents for Kidney Stones
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether a hemostatic agent (a substance that helps stop bleeding) can reduce bleeding during a kidney stone procedure called percutaneous nephrolithotomy (PCNL). Participants will either receive a hemostatic agent or not, and the study will compare the outcomes. The goal is to determine if these agents help reduce the drop in hemoglobin (a protein in blood that carries oxygen) during and after the procedure. Individuals with a kidney stone larger than 1.2 cm who are scheduled for PCNL might be suitable candidates for this trial. As an unphased trial, this study offers participants the chance to contribute to important research that could improve future kidney stone procedures.
Do I need to stop my current medications for the trial?
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 trial's treatments are likely to be safe?
Previous studies have used treatments like Floseal, Surgicel, and Surgiflo to help stop bleeding during surgeries. Research has shown that these products are generally safe for patients.
One study found no complications, such as bleeding or urine leaks, when Floseal was used correctly in kidney stone procedures, suggesting its safety for these treatments.
Surgicel has been studied and is considered effective in reducing bleeding. Although specific safety data is limited, its common use in surgeries suggests it is usually safe for patients.
Reports indicate that Surgiflo reduces issues like urine leakage in kidney stone surgeries, suggesting it can be a safe option for managing bleeding.
While each product has shown positive safety results, discussing any concerns with healthcare providers before joining a trial is always important.12345Why are researchers excited about this trial?
Researchers are excited about these treatments for kidney stones because they explore different hemostatic agents to control bleeding during surgical procedures. Unlike standard practices that typically involve direct pressure or cauterization, these treatments incorporate agents like Floseal, Surgicel, and Surgiflo with balloon tamponade. These agents work by enhancing the body's natural ability to form clots, potentially reducing bleeding more effectively and quickly. This approach could lead to less invasive procedures, reduced recovery time, and better overall outcomes for patients undergoing kidney stone surgery.
What evidence suggests that this trial's treatments could be effective for tract-related bleeding during PCNL?
This trial will compare the effectiveness of different hemostatic agents used during kidney stone removal surgery. Research has shown that agents like Floseal, Surgicel, and Surgiflo can help control bleeding. Participants in this trial will receive Balloon Tamponade with one of these agents or Balloon Tamponade alone as a control. Specifically, studies have found that Floseal effectively clears stones without causing bleeding problems. Surgicel is known for its safety and efficiency in surgeries, while Surgiflo has demonstrated good results in reducing bleeding. These agents aid blood clotting at the surgery site, potentially reducing blood loss during procedures like percutaneous nephrolithotomy (PCNL). While each agent appears promising, their exact effectiveness in reducing blood loss and improving blood clotting during PCNL is still under investigation in this trial.25678
Who Is on the Research Team?
Mantu Gupta, MD
Principal Investigator
Icahn School of Medicine at Mount Sinai
Are You a Good Fit for This Trial?
This trial is for people undergoing a kidney stone removal procedure called PCNL. Participants must be eligible for this surgery and able to follow the study protocol. People with conditions that could interfere with healing or increase bleeding risk may not qualify.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients undergo standardized PCNL with or without a hemostatic agent during tract closure
Follow-up
Participants are monitored for safety and effectiveness after treatment, including hemoglobin level assessments
What Are the Treatments Tested in This Trial?
Interventions
- Balloon Tamponade
- Floseal
- Surgicel
- Surgiflo
Trial Overview
The study compares different ways to stop bleeding after PCNL: using hemostatic agents (like Floseal, Surgicel, or Surgiflo) versus just balloon tamponade during tract closure. Patients are randomly assigned to each group.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Active Control
Balloon tamponade with Surgilfo as hemostatic agent.
Balloon Tamponade with Surgicel as hemostatic agent.
Balloon tamponade with Floseal as hemostatic agent.
Balloon tamponade alone with no hemostatic agent acts as a control.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Icahn School of Medicine at Mount Sinai
Lead Sponsor
Citations
Occlusion Balloon vs. Ureteral Catheter for Kidney Stones
One study found that using this catheter before kidney stone removal surgery improved the success rate in 60 out of 71 patients, particularly those with ...
Safety, feasibility, and efficacy of surgical intervention for ...
This systematic review evaluates the safety, feasibility, and efficacy of surgical interventions for urolithiasis chronic kidney disease (CKD).
The evaluations of ESWL, RIRS and m-PCNL treatments in ...
At the end of the first month, stone-free rate for the lower calyx stones was 33.3% (3 patients out of 10) in ESWL, 83.3% (10 patients out of 12) in RIRS, and ...
A Prospective, Randomized Trial Evaluating the Safety and ...
Complete stone clearance was achieved in 87.5% of patients in the experimental group and in 90.32% of controls.
Review Advances in percutaneous stone surgery
balloon dilation may result in less renal trauma and a reduced risk of dislodging the safety wire
Guidelines - EAU Guidelines on Urolithiasis
This chapter provides comprehensive guidance on urolithiasis, covering stone classification, diagnostic evaluation, disease management and recurrence ...
Study Details | NCT07172373 | Safety and Effectiveness of ...
Excessive angulation of the nephroscope may increase the risk of infundibular tears and bleeding, stone-free increases the risks of bleeding, ...
The Technique of Precise Injection of Floseal Along ...
There were no complications reported, including bleeding or urine leaks. In particular, there were no wound complications. the wound complication was 20%.
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.