UrolithiasisNCT02875717
Influence of Acetylsalicylic Acid and Low Molecular Weight Heparins on the Incidence of Renal Hematoma of Shockwave Lithotripsy
An observational study of Urolithiasis and Renal Hematoma, run by Kantonsspital Winterthur KSW at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urolithiasis, Renal Hematoma
- What is being tested?
- Acetylsalicylic acid and low molecular weight heparin
- How many people
- 500 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2009to Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- consent
- Stones in kidney and proximal Ureter
- Treatment with shockwave lithotripsy for urolithiasis between January 2009 and September 2015 at Kantonsspital Winterthur
Who cannot join
- other Position of ureteral Stones
- missing data in Patient reports
- refused consent
- under Age limit
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Kantonsspital Winterthur
Winterhur, Canton of Zurich, 8401
About this study
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.
- Conditions
- Urolithiasis, Renal Hematoma
- Being tested
- Acetylsalicylic acid, low molecular weight heparin
- Medical subject headings
- Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetylsalicylic acidDrug
low molecular weight heparinDrug
| Study group | Role | What they receive |
|---|---|---|
| Control | Not described | |
| Acetylsalicylic acid | Patients that were on medication with Acetylsalicylic acid on the date of shockwave lithotripsy Receives: Drug: Acetylsalicylic acid | |
| Low Molecular weight heparin | Patients that were on medication with low molecular heparin on the date of shockwave lithotripsy Receives: Drug: low molecular weight heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal Hematoma in ultrasound control
Measured: first day after intervention
Secondary outcomes (4)
Intervention for bleeding control
Measured: 30 days after intervention
Need for erythrocyte concentrate tranfusion
Measured: 30 days after intervention
Death
Measured: 30 days after intervention
Hospital readmission
Measured: 30 days after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2016 (estimated)
- Study startJan 2009
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for UrolithiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Winterthur KSW
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christoph Schregel, Kantonsspital Winterthur KSW
- Investigators
- Hubert John, M.D., Principal investigator, Kantonsspital Winterthur KSW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02875717
- Sponsor's protocol ID
- 2015-0662/PB_2016-00897
- Status last verified
- Aug 2016
- First submitted
- 18 Aug 2016
- Last updated
- 23 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Schregel C, John H, Randazzo M, Keller I. Influence of acetylsalicylic acid and low-molecular weight heparins on the formation of renal hematoma after shock wave lithotripsy. World J Urol. 2017 Dec;35(12):1939-1946. doi: 10.1007/s00345-017-2070-0. Epub 2017 Jul 12.
PubMed 28702844
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Acetylsalicylic Acid and Low Molecular Weight Heparins on the Incidence of Renal Hematoma of Shockwave Lithotripsy
- ClinicalTrials.gov ID
- NCT02875717
- Acronym / sponsor ID
- 2015-0662/PB_2016-00897
- Conditions
- Urolithiasis, Renal Hematoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Kantonsspital Winterthur KSWUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 23 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | – | – |
| Acetylsalicylic acid | – | Drug: Acetylsalicylic acidPatients that were on medication with Acetylsalicylic acid on the date of shockwave lithotripsy |
| Low Molecular weight heparin | – | Drug: low molecular weight heparinPatients that were on medication with low molecular heparin on the date of shockwave lithotripsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- consent
- Stones in kidney and proximal Ureter
- Treatment with shockwave lithotripsy for urolithiasis between January 2009 and September 2015 at Kantonsspital Winterthur
Key exclusion criteria (4 listed)
- other Position of ureteral Stones
- missing data in Patient reports
- refused consent
- under Age limit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acetylsalicylic acid | Drug | Acetylsalicylic acid |
| low molecular weight heparin | Drug | Low Molecular weight heparin |
Primary outcome
Renal Hematoma in ultrasound control
Time frame: first day after intervention
4 secondary outcomes
Intervention for bleeding control
Time frame: 30 days after intervention
Need for erythrocyte concentrate tranfusion
Time frame: 30 days after intervention
Death
Time frame: 30 days after intervention
Hospital readmission
Time frame: 30 days after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2016.
- Derived from this study: PubMed 28702844Schregel C, John H, Randazzo M, Keller I. Influence of acetylsalicylic acid and low-molecular weight heparins on the formation of renal hematoma after shock wave lithotripsy. World J Urol. 2017 Dec;35(12):1939-1946. doi: 10.1007/s00345-017-2070-0. Epub 2017 Jul 12.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hubert John, M.D. principal investigator
Kantonsspital Winterthur KSW
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urolithiasis and Renal Hematoma, run by Kantonsspital Winterthur KSW at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal Hematoma in ultrasound control (time frame: first day after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02875717, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2016.