Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID03437057

Study of Acetylsalicylic Acid (Aspirin) at 250 mg or Less During Extracorporeal Lithotripsy for Kidney Stones Prospective Single-Arm Study Evaluating Kidney Bleeding Risk and Treatment Outcomes

Led by University Hospital, Clermont-Ferrand · Updated on 2025-01-17

300

Participants Needed

1

Research Sites

477 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the safety of maintaining low-dose acetylsalicylic acid (aspirin) treatment at or below 250 mg during extracorporeal lithotripsy (ECL) sessions for patients with kidney stones. Kidney stones are increasingly common due to lifestyle and dietary changes, affecting about 10% of the French population. ECL is a common non-invasive treatment used for kidney stones smaller than 20 mm, but it carries a risk of causing renal hematomas, which this study aims to evaluate specifically on a 15-day scan. The study is a prospective, single-arm trial involving patients who continue their low-dose aspirin during ECL without stopping the medication beforehand. Prior to the procedure, patients undergo imaging and blood tests, and during the ECL session, blood pressure and pain are monitored. After treatment, patients receive follow-up scans at 15 days to check for renal hematomas and assess stone clearance, along with blood tests and pain evaluations. A follow-up consultation occurs about three weeks after the procedure to review outcomes and any complications. Participants will be closely monitored through imaging, laboratory tests, pain assessments, and medical history reviews throughout the study period, which is estimated to last around 5 to 6 weeks per patient. The main outcome measured is the proportion of patients developing renal hematomas after ECL while on aspirin, along with secondary outcomes including treatment effectiveness, hematuria occurrence, pain, post-treatment complications, and renal function changes. The study aims to simplify patient management and reduce cardiovascular risks by avoiding aspirin interruption during lithotripsy.

CONDITIONS

Official Title

Maintenance of an Antiaggregation by Acetylsalicylic Acid, While a Extracorporeal Lithotripsy Session on a Kidney Stone is Perfomed: Comparative Unicentric Prospective Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 years or older
  • Patients with at least one kidney stone requiring extracorporeal lithotripsy
  • Patients taking Kardegic 75 mg as monotherapy
Not Eligible

You will not qualify if you...

  • Patients with known or previously known bleeding disorders based on pre-treatment tests
  • Patients on anticoagulant or other anti-platelet therapies (e.g., Kardegic above 75 mg, AVK, NACO, LMWH, HNF, P2Y12 inhibitors)
  • Patients with any other contraindications to extracorporeal lithotripsy
  • Patients prescribed more than one ECL session
  • Patients under guardianship, deprived of liberty, lacking social security affiliation, with impaired understanding, pregnant or breastfeeding women

AI-Screening

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Trial Site Locations

Total: 1 location

1

CHU Clermont-Ferrand

Clermont-Ferrand, France, 63003

Actively Recruiting

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Research Team

L

Lise LACLAUTRE

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

1

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Published Research Related To This Trial

New aspects of urolithiasis in France. GERBAP: Groupe d'Evaluation et de Recherche des Biologistes de l'Assistance Publique des Hôpitaux de Paris.

R Donsimoni, C Hennequin, S Fellahi...

https://pubmed.ncbi.nlm.nih.gov/9032529

Changes in stone composition according to age and gender of patients: a multivariate epidemiological approach.

Michel Daudon, Jean-Christophe Doré, Paul Jungers...

https://pubmed.ncbi.nlm.nih.gov/15127165

Pediatric urolithiasis: 15 years of local experience with minimally invasive endourological management of pediatric calculi.

Asif Raza, Burak Turna, Gordon Smith...

https://pubmed.ncbi.nlm.nih.gov/16006948

Extracorporeal shock wave lithotripsy as first line treatment for urinary tract stones in children: outcome of 500 cases.

Abdelbasset A Badawy, Mohamed D Saleem, Ahmad Abolyosr...

https://pubmed.ncbi.nlm.nih.gov/22350835