Clinical trial NCT03437057: Maintenance of an Antiaggregation by Acetylsalicylic Acid, While a Extracorporeal Lithotripsy Session on a Kidney Stone is Perfomed: Comparative Unicentric Prospective Study
Official title: Maintenance of an Antiaggregation by Acetylsalicylic Acid, Less or Equal to 250mg While a Extracorporeal Lithotripsy (ECL) Session on a Kidney Stone is Perfomed: Comparative Unicentric Prospective Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Renal Lithiasis
Antiplatelet
Hematoma
Keywords: ECL
Hematoma
Antiplatelet
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2018-02-19
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Background/Rationale for the study:

Lithiasis pathology is increasingly common because of the change in our lifestyle and our food. Thus, we hold a prevalence for urinary lithiasis 10% in France currently including 13% of the male population and 6% of the female population.

The formation of urinary lithiasis is the result of a complex mechanism involving factors anatomical and infectious metabolics. They are classified according to their size, topography and composition.

The treatment of urinary lithiasis has changed dramatically in recent years. The recommendations of the French Urology Association (AFU) for the management of kidney stones and ureteral of the adult of 2004 give a certain place to the treatment by extracorporeal lithotripsy (ECL).

The ELC is indicated for the first purpose for lithiasis ureteral or renal lithiasis of less than 20 mm, whether or not associated with the setting up of a JJ stent. For kidney stones of more than 20 mm or complex or Coralliformes, the ECL can be associated with treatment with percutaneous nephrolithotomy. In addition, the ECL is indicated in case of residual cholelithiasis 3 months after a first treatment whatsoever.

It is found, as the main complication of the ECL, a risk of the appearance of Hematomas under capsular, peri-renal and intra-parenchymatous. Its prevalence is estimated to be between 6.2% and 13% according to studies.

ACETYLSALICYLIC ACID less or equal to 250 mg is the usual dosage of aspirin (for the adult), the Marketing Autorisation recognises in secondary prevention after a first myocardial or cerebral ischemic attack related to atherosclerosis. It entrains a reduction mortality and morbidity of cardiovascular causes.

Acetylsalicylic acid is currently being stopped 5 to 7 days before the ECL. The interest of maintaining the Acetylsalicylic acid is:

* A simplification of the management of patients under on acetylsalicylic acid below (or equal to) 250 mg (No modification of Treatment to be implemented)
* A cardiovascular risk decreased by maintaining their initial treatment without any modification.

Main objective:

Evaluation of the proportion of renal hematoma during the production of Lithotripsy for renal lithiasis, on a 15-day scan, in patients under on acetylsalicylic acid below (or equal to) 250 mg not stopped

Secondary objectives:

Evaluation of the efficacy of treatment with lithotripsy (Stone free, fragments Minimal residuals) Evaluation of the proportion of hematuria macroscopic post lithotripsy in Patients under on acethylsalicylic acid not stopped. Evaluate the rate of post-ECL complications requiring treatment, Analgesic, obstructive pyelonephritis.

Evaluate post-ECL pain due to hematoma or lithiasis migration Evaluation of the evolution of renal function post session of Lithotripsy on the patients under acethylsalicylic acid not stopped.

Type of Study: Interventional study, prospective, mono centric, single-arm

Detailed description: Before the ECL:

Patients will be recruited during the urology consultation prior to the lithotripsy for kidney stones Kidneys (JJ stent in place or not) using an uninjected abdominal-pelvic or ultrasound scanner Renal coupled to a AUSP (urinary tree without preparation). ECL is an Unbody method that allows the calculation to be fragmented using shock waves Generated by a lithotripter. It will be given to them, after explanation of this method by the doctor during the consultation, a AFU information sheet on the ECL explaining its steps, possible complications, its follow-up.

After checking the inclusion and non-inclusion criteria, patients will be programmed to ECL without prior stop of acethylsalicylic acid.

At the ECL session:

Evaluation of blood pressure before the session and at the end. Medical history and treatment will be notified in the patient file Verification of blood balance (coagulation, renal function) and urinary (BU and ECBU) Evaluation of pain by analog visual scale (AVS) before and during the session. Notification of possible symptoms (adverse reactions = AR) in the medical file. Prescription of analgesics as well as blood balance and revaluation scanner at D15 Taking a post-ECL appointment with the reference urologist at D23 (+-2days)

After the ECL session: 3-week post-ECL Consultation:

Pain Assessment (AVS) Evaluation of the effectiveness of the ECL (stone clearance)

Reading of the scanner performed at D15 in search of a hematoma "(the scanner will also be replayed from systematically by the prescriber or a urologist of the service looking for a hematoma and the level of efficacy of the ECL + control of the blood balance in search of a inflammatory/infectious/anemia/renal function Chronology of the essay:

Duration of study estimated at: 5 years Start date of study (first patient included): 01/2018 End Date (end of follow-up of the last patient of the study): 01/2023 Total duration of participation in the study for the patient: 5 to 6 weeks The end-of-study date shall be transmitted to the competent authority and the MPC within 90 days.

If the study is to stop prematurely, the information will be transmitted within a period of 15 days The competent authority and the MPC. Main judgement criterion: Proportion of patients with renal hematoma when performing of lithotripsy for renal lithiasis, on a 15-day scanner.

Number of topics: 300 based on a 4-step sequential plan of Fleming type

Inclusion criteria:

Patients over 18 years of age benefiting from the social security scheme Patients with at least one renal lithiasis requiring treatment with extracorporeal lithotripsy (ECL)

Non-inclusion criteria:

Coagulation disorder known or discovered on the pre-therapeutic balance sheet Associated anticoagulant therapy. Presence of another contraindications to the ECL.

Conduct of the study:

Study is carried out in current practice at the CHU of Clermont Ferrand in the Department of Urology.

The patient will be seen in consultation by the urologist who shall prescribe the Lithotripsy sessions, inform him about the of the session and will provide him a AFU information sheet concerning the stages of the session, and then, prescribe a blood test to be presented to the lithotriptor on the day of the examination. Not additional accommodation to plan. The patient will return 3 weeks after the ECL session for his evaluation with the urologist. He will have previously completed a blood check and a 15-day scan of the lithotripsy session (instead of about 3 weeks usually).

Benefits and risks of this study:

Simplify patient management under acethylsalicylic acid. Decrease in cardiovascular risk by maintaining the acethylsalicylic acid. Increase of the risk of post-ECL hematoma

Eligibility criteria: Inclusion Criteria

* Over 18 yo patients
* Patients with 1 renal lithiasis (at least) requiring treatment with extracorporeal lithotripsy
* Patients taking Kardégic 75 (monotherapy

Exclusion Criteria:

* Patients with known (or previously known) bleeding disorders on the pre-treatment assessment
* Patients with anticoagulant therapy or other anti-aggregating therapy (eg Kardegic at 75mg, AVK, NACO, LMWH, HNF, P2Y12 inhibitor)
* Patients with another contrindication to the ECL.
* Patients with prescription of more than the outset 1 ECL session
* Tutelage, curatorship, justice safeguarding, deprived of liberties, unaffiliated SS, impaired comprehension abilities, pregnant and lactating women.

Primary outcomes:
measure: Evaluation of the proportion of renal hematoma during the production of Lithotripsy for renal lithiasis
timeFrame: at 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Marlène GUANDALINO, MD
role: STUDY_DIRECTOR
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