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

August 18, 2016 updated by: Christoph Schregel, Kantonsspital Winterthur KSW
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Kanton Zürich
      • Winterhur, Kanton Zürich, Switzerland, 8401
        • Kantonsspital Winterthur

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients that received shockwave lithotripsy at Kantonsspital Winterthur between January 2009 and September 2015 and were 18 years or older at the time of treatment

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Renal Hematoma in ultrasound control
Time Frame: first day after intervention
first day after intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Intervention for bleeding control
Time Frame: 30 days after intervention
30 days after intervention
Need for erythrocyte concentrate tranfusion
Time Frame: 30 days after intervention
30 days after intervention
Death
Time Frame: 30 days after intervention
30 days after intervention
Hospital readmission
Time Frame: 30 days after intervention
30 days after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kantonsspital Winterthur KSW

Investigators

  • Principal Investigator: Hubert John, M.D., Kantonsspital Winterthur KSW

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

August 18, 2016

First Submitted That Met QC Criteria

August 18, 2016

First Posted (Estimate)

August 23, 2016

Study Record Updates

Last Update Posted (Estimate)

August 23, 2016

Last Update Submitted That Met QC Criteria

August 18, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-0662/PB_2016-00897

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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