Maintenance of an Antiaggregation by Acetylsalicylic Acid, While a Extracorporeal Lithotripsy Session on a Kidney Stone is Perfomed: Comparative Unicentric Prospective Study
NCT ID: NCT03437057
Last Updated: 2025-01-17
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
300 participants
Study Classification
INTERVENTIONAL
Study Start Date
2018-01-08
Study Completion Date
2027-03-31
Brief Summary
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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
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
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Detailed Description
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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
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
Conditions
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Renal Lithiasis
Antiplatelet
Hematoma
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
HEALTH_SERVICES_RESEARCH
Blinding Strategy
NONE
Study Groups
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Patients treated with acethylsalicylic acid 250 mg
Prospective single-arm study to estimate the risk of renal hematoma when performing a session of lithotripsy for renal lithiasis, on a 15-day scanner, in patients treated with acetylsalicylic acid not suspended.
Group Type
EXPERIMENTAL
acetylsalicylic acid (below or equal to) 250 mg
Intervention Type
OTHER
Prospective single-arm study to estimate the risk of renal hematoma when performing a session of lithotripsy for renal lithiasis, on a 15-day scanner, in patients treated with acetylsalicylic acid not suspended.
Interventions
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acetylsalicylic acid (below or equal to) 250 mg
Prospective single-arm study to estimate the risk of renal hematoma when performing a session of lithotripsy for renal lithiasis, on a 15-day scanner, in patients treated with acetylsalicylic acid not suspended.
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
* Over 18 yo patients
* Patients with 1 renal lithiasis (at least) requiring treatment with extracorporeal lithotripsy
* Patients taking Kardégic 75 (monotherapy
* 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.
* 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.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University Hospital, Clermont-Ferrand
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Marlène GUANDALINO, MD
Role: STUDY_DIRECTOR
University Hospital, Clermont-Ferrand
Locations
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CHU Clermont-Ferrand
Clermont-Ferrand, , France
Site Status
RECRUITING
Countries
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France
Central Contacts
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Facility Contacts
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References
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Donsimoni R, Hennequin C, Fellahi S, Troupel S, Moel GL, Paris M, Lacour B, Daudon M. New aspects of urolithiasis in France. GERBAP: Groupe d'Evaluation et de Recherche des Biologistes de l'Assistance Publique des Hopitaux de Paris. Eur Urol. 1997;31(1):17-23.
Reference Type
BACKGROUND
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BACKGROUND
Daudon M, Dore JC, Jungers P, Lacour B. Changes in stone composition according to age and gender of patients: a multivariate epidemiological approach. Urol Res. 2004 Jun;32(3):241-7. doi: 10.1007/s00240-004-0421-y. Epub 2004 May 4.
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Streem SB, Yost A, Mascha E. Clinical implications of clinically insignificant store fragments after extracorporeal shock wave lithotripsy. J Urol. 1996 Apr;155(4):1186-90.
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BACKGROUND
Tolley DA. Consensus of lithotriptor terminology. World J Urol. 1993;11(1):37-42. doi: 10.1007/BF00182170.
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Candau C, Saussine C, Lang H, Roy C, Faure F, Jacqmin D. Natural history of residual renal stone fragments after ESWL. Eur Urol. 2000 Jan;37(1):18-22. doi: 10.1159/000020093.
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Badawy AA, Saleem MD, Abolyosr A, Aldahshoury M, Elbadry MS, Abdalla MA, Abuzeid AM. Extracorporeal shock wave lithotripsy as first line treatment for urinary tract stones in children: outcome of 500 cases. Int Urol Nephrol. 2012 Jun;44(3):661-6. doi: 10.1007/s11255-012-0133-0. Epub 2012 Feb 16.
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Ather MH, Noor MA. Does size and site matter for renal stones up to 30-mm in size in children treated by extracorporeal lithotripsy? Urology. 2003 Jan;61(1):212-5; discussion 215. doi: 10.1016/s0090-4295(02)02128-3.
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Al-Busaidy SS, Prem AR, Medhat M. Pediatric staghorn calculi: the role of extracorporeal shock wave lithotripsy monotherapy with special reference to ureteral stenting. J Urol. 2003 Feb;169(2):629-33. doi: 10.1097/01.ju.0000047231.36474.57.
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Ozgur Tan M, Karaoglan U, Sozen S, Bozkirli I. Extracorporeal shock-wave lithotripsy for treatment of ureteral calculi in paediatric patients. Pediatr Surg Int. 2003 Aug;19(6):471-4. doi: 10.1007/s00383-003-0961-1. Epub 2003 May 8.
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Onal B, Demirkesen O, Tansu N, Kalkan M, Altintas R, Yalcin V. The impact of caliceal pelvic anatomy on stone clearance after shock wave lithotripsy for pediatric lower pole stones. J Urol. 2004 Sep;172(3):1082-6. doi: 10.1097/01.ju.0000135670.83076.5c.
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Ozgur Tan M, Karaoglan U, Sen I, Deniz N, Bozkirli I. The impact of radiological anatomy in clearance of lower calyceal stones after shock wave lithotripsy in paediatric patients. Eur Urol. 2003 Feb;43(2):188-93. doi: 10.1016/s0302-2838(02)00492-x.
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BACKGROUND
Bellin MF, Renard-Penna R, Conort P, Bissery A, Meric JB, Daudon M, Mallet A, Richard F, Grenier P. Helical CT evaluation of the chemical composition of urinary tract calculi with a discriminant analysis of CT-attenuation values and density. Eur Radiol. 2004 Nov;14(11):2134-40. doi: 10.1007/s00330-004-2365-6. Epub 2004 Jun 25.
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Pearle MS, Roehrborn CG. Antimicrobial prophylaxis prior to shock wave lithotripsy in patients with sterile urine before treatment: a meta-analysis and cost-effectiveness analysis. Urology. 1997 May;49(5):679-86. doi: 10.1016/S0090-4295(96)00626-7.
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Leusmann DB, Tschuschke C, Stenzinger W. Extracorporeal shock wave lithotripsy of renal calculi in a patient with haemophilia A complicated by a high titre factor VIII inhibitor. Br J Urol. 1995 Mar;75(3):415-6. doi: 10.1111/j.1464-410x.1995.tb07364.x. No abstract available.
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BACKGROUND
Knapp PM, Kulb TB, Lingeman JE, Newman DM, Mertz JH, Mosbaugh PG, Steele RE. Extracorporeal shock wave lithotripsy-induced perirenal hematomas. J Urol. 1988 Apr;139(4):700-3. doi: 10.1016/s0022-5347(17)42604-8.
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Newman LH, Saltzman B. Identifying risk factors in development of clinically significant post-shock-wave lithotripsy subcapsular hematomas. Urology. 1991 Jul;38(1):35-8. doi: 10.1016/0090-4295(91)80009-v.
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Delius M, Enders G, Xuan ZR, Liebich HG, Brendel W. Biological effects of shock waves: kidney damage by shock waves in dogs--dose dependence. Ultrasound Med Biol. 1988;14(2):117-22. doi: 10.1016/0301-5629(88)90178-0.
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BACKGROUND
Burger W, Chemnitius JM, Kneissl GD, Rucker G. Low-dose aspirin for secondary cardiovascular prevention - cardiovascular risks after its perioperative withdrawal versus bleeding risks with its continuation - review and meta-analysis. J Intern Med. 2005 May;257(5):399-414. doi: 10.1111/j.1365-2796.2005.01477.x.
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BACKGROUND
Ueda S, Matsuoka K, Yamashita T, Kunimi H, Noda S, Eto K. Perirenal hematomas caused by SWL with EDAP LT-01 lithotripter. J Endourol. 1993 Feb;7(1):11-5. doi: 10.1089/end.1993.7.11.
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Oscarsson A, Gupta A, Fredrikson M, Jarhult J, Nystrom M, Pettersson E, Darvish B, Krook H, Swahn E, Eintrei C. To continue or discontinue aspirin in the perioperative period: a randomized, controlled clinical trial. Br J Anaesth. 2010 Mar;104(3):305-12. doi: 10.1093/bja/aeq003.
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BACKGROUND
Ferrari E, Benhamou M, Cerboni P, Marcel B. Coronary syndromes following aspirin withdrawal: a special risk for late stent thrombosis. J Am Coll Cardiol. 2005 Feb 1;45(3):456-9. doi: 10.1016/j.jacc.2004.11.041.
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BACKGROUND
Collet JP, Montalescot G, Blanchet B, Tanguy ML, Golmard JL, Choussat R, Beygui F, Payot L, Vignolles N, Metzger JP, Thomas D. Impact of prior use or recent withdrawal of oral antiplatelet agents on acute coronary syndromes. Circulation. 2004 Oct 19;110(16):2361-7. doi: 10.1161/01.CIR.0000145171.89690.B4. Epub 2004 Oct 11.
Reference Type
BACKGROUND
Telegrafo M, Carluccio DA, Rella L, Ianora AA, Angelelli G, Moschetta M. Diagnostic and prognostic role of computed tomography in extracorporeal shock wave lithotripsy complications. Urol Ann. 2016 Apr-Jun;8(2):168-72. doi: 10.4103/0974-7796.163792.
Reference Type
BACKGROUND
Other Identifiers
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2017- A01453-50
Identifier Type: OTHER
Identifier Source: secondary_id
RBHP_2017_GUANDALINO
Identifier Type: -
Identifier Source: org_study_id
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NA
Antibiotic Prophylaxis Before Shock Wave Lithotripsy
NCT03692715
COMPLETED
PHASE4
A Study on the Effection of Potassium Citrate Extended-release Tablets on Urolithiasis Formation or Recurrence
NCT03007160
UNKNOWN
PHASE4
Metabolic Risk Factors and Stones Composition in Adult Kidney Stone Formers
NCT04243772
COMPLETED
Extra-Corporeal Shock Wave Lithotripsy for Renal and Upper Ureteral Stones in Adults Under Locally Infiltrate d Anaesthetics ; a Clinical Randomized Controlled Study
NCT06462573
NOT_YET_RECRUITING
EARLY_PHASE1
Comparison Between Ureterorenoscopy With Lithotripsy Alone Versus Combination With Hydrogel for Kidney Stone Removal
NCT06469736
RECRUITING
NA
ESWL vs URS in Management of Upper Third Ureteric Calculi
NCT03559738
COMPLETED
Citrate Salts for Stone-free Result After Flexible Ureterorenoscopy for Inferior Calyx Calculi
NCT04021381
UNKNOWN
PHASE3
Urine and Stool Analysis in Kidney Stone Disease
NCT01637506
UNKNOWN
Evaluation of Tamsulosin in the Treatment of Ureteral Stones
NCT00151567
COMPLETED
PHASE3
The Use of Tamsulosin in Treatment of (10-15 mm) Lower Ureteric Stones in Adults With Non-emergent Symptoms
NCT03274700
UNKNOWN
EARLY_PHASE1
Silent Ureteral Stone: Impact on Renal Function and Kidney Anatomy
NCT01884870
UNKNOWN
NA
Medical Expulsive Therapy Post-SWL For Renal Stones
NCT05032287
COMPLETED
NA
Efficacy and Safety of Using MPC-5971 in Subjects Undergoing Shock Wave Lithotripsy
NCT00860093
TERMINATED
PHASE2