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

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ClinicalTrials.gov Identifier: NCT02875717
Recruitment Status : Completed
First Posted : August 23, 2016
Last Update Posted : August 23, 2016
Sponsor:
Information provided by (Responsible Party):
Christoph Schregel, Kantonsspital Winterthur KSW

Study Description
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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
Urolithiasis Renal Hematoma Drug: Acetylsalicylic acid Drug: low molecular weight heparin

Study Design
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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 : January 2009
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Renal Hematoma in ultrasound control [ Time Frame: first day after intervention ]

Secondary Outcome Measures :
  1. Intervention for bleeding control [ Time Frame: 30 days after intervention ]
  2. Need for erythrocyte concentrate tranfusion [ Time Frame: 30 days after intervention ]
  3. Death [ Time Frame: 30 days after intervention ]
  4. Hospital readmission [ Time Frame: 30 days after intervention ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02875717


Locations
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Switzerland
Kantonsspital Winterthur
Winterhur, Kanton Zürich, Switzerland, 8401
Sponsors and Collaborators
Kantonsspital Winterthur KSW
Investigators
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Principal Investigator: Hubert John, M.D. Kantonsspital Winterthur KSW
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Christoph Schregel, Resident, Kantonsspital Winterthur KSW
ClinicalTrials.gov Identifier: NCT02875717    
Other Study ID Numbers: 2015-0662/PB_2016-00897
First Posted: August 23, 2016    Key Record Dates
Last Update Posted: August 23, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Urolithiasis
Hematoma
Hemorrhage
Pathologic Processes
Urologic Diseases
Aspirin
Heparin
Heparin, Low-Molecular-Weight
Tinzaparin
Dalteparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
 Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics