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

Sponsor

Kantonsspital Winterthur KSW (Other)

Overall Status

Completed

CT.gov ID

NCT02875717

Collaborator

(none)

500

Enrollment

Location

Duration (Months)

6.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Urolithiasis Renal Hematoma	Drug: Acetylsalicylic acid Drug: low molecular weight heparin

Study Design

Study Type:

Observational

Actual Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Study Start Date :

Jan 1, 2009

Actual Primary Completion Date :

Sep 1, 2015

Actual Study Completion Date :

Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Control
Acetylsalicylic acid Patients that were on medication with Acetylsalicylic acid on the date of shockwave lithotripsy	Drug: Acetylsalicylic acid
Low Molecular weight heparin Patients that were on medication with low molecular heparin on the date of shockwave lithotripsy	Drug: low molecular weight heparin

Arm

Intervention/Treatment

Control

Acetylsalicylic acid

Patients that were on medication with Acetylsalicylic acid on the date of shockwave lithotripsy

Drug: Acetylsalicylic acid

Low Molecular weight heparin

Patients that were on medication with low molecular heparin on the date of shockwave lithotripsy

Drug: low molecular weight heparin

Outcome Measures

Primary Outcome Measures

Renal Hematoma in ultrasound control [first day after intervention]

Secondary Outcome Measures

Intervention for bleeding control [30 days after intervention]
Need for erythrocyte concentrate tranfusion [30 days after intervention]
Death [30 days after intervention]
Hospital readmission [30 days after intervention]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

consent
Stones in kidney and proximal Ureter
Treatment with shockwave lithotripsy for urolithiasis between January 2009 and September 2015 at Kantonsspital Winterthur