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NCT02875717 Clinical Trial

Influence of Acetylsalicylic Acid and Low Molecular Weight Heparins on the Incidence of Renal Hematoma of Shockwave Lithotripsy

Urolithiasis Clinical Trial

Official title:
Influence of Acetylsalicylic Acid and Low Molecular Weight Heparins on the Incidence of Renal Hematoma of Shockwave Lithotripsy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02875717
Other study ID # 2015-0662/PB_2016-00897
Secondary ID
Status Completed
Phase N/A
First received August 18, 2016
Last updated August 18, 2016
Start date January 2009
Est. completion date September 2015

Study information
Verified date August 2016
Source Kantonsspital Winterthur KSW
Contact n/a
Is FDA regulated No
Health authority Switzerland: EthikkommissionSwitzerland: Laws and standards
Study type Observational

Clinical Trial Summary

Retrospective Analysis of patients that received shockwave lithotripsy as Treatment of ureteral or kidney Stones. Condition examinated is the effect of low molecular weight Heparins and acetylsalicylic acid on the Formation of renal hematoma after shockwave lithotripsy. Primary outcome is documented hematoma in a postoperative ultrasound control. Secondary outcomes are perioperative complication, Need for erythrocyte tranfusion, interventions for bleeding control, readmission or death within 30 days.

Recruitment information / eligibility
Status Completed
Enrollment 500
Est. completion date September 2015
Est. primary completion date September 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- consent

- Stones in kidney and proximal Ureter

- Treatment with shockwave lithotripsy for urolithiasis between January 2009 and September 2015 at Kantonsspital Winterthur

Exclusion Criteria:

- other Position of ureteral Stones

- missing data in Patient reports

- refused consent

- under Age limit

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Drug:
• Acetylsalicylic acid

• low molecular weight heparin

Locations
Country Name City State
Switzerland Kantonsspital Winterthur Winterhur Kanton Zürich

Sponsors (1)
Lead Sponsor Collaborator
Kantonsspital Winterthur KSW

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Renal Hematoma in ultrasound control first day after intervention Yes
Secondary Intervention for bleeding control 30 days after intervention Yes
Secondary Need for erythrocyte concentrate tranfusion 30 days after intervention Yes
Secondary Death 30 days after intervention Yes
Secondary Hospital readmission 30 days after intervention Yes
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