Treatment ProcedureNCT03006120
Treatment Management and Factors Affecting Mortality in Retroperitoneal Hemorrhage Due to Cardiac Catheterization; Single Center Experience
An observational study of Treatment Procedure and Mortality, run by Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital.
Trial summary
Bleeding complications after cardiac catheterization have been reviewed previously, but there are very few studies on retroperitoneal hematoma and appropriate treatment of patients is not well defined. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Treatment Procedure, Mortality
- What is being tested?
- Retroperitoneal hematoma due to cardiac catheterization
- Type of treatment
- Surgery or procedure
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Dec 2016
- 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: Retroperitoneal hematoma following cardiac catheterization in our institution between January 2010 and October 2016.
Who may be able to join
- Retroperitoneal hematoma following cardiac catheterization
Who cannot join
- Patients with retroperitoneal hematomas other than cardiac catheterization and patients with missing file records.
About this study
Bleeding complications after cardiac catheterization have been reviewed previously, but there are very few studies on retroperitoneal hematoma and appropriate treatment of patients is not well defined. For this reason, the investigators aimed to analyze the clinical manifestations of retroperitoneal hematomas in a single center using a case-control study design, to analyze the treatment procedure determinants and consequently to provide an updated and usable treatment algorithm.
- Conditions
- Treatment Procedure, Mortality
- Being tested
- Retroperitoneal hematoma due to cardiac catheterization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retroperitoneal hematoma due to cardiac catheterizationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Conservative management Receives: Procedure: Retroperitoneal hematoma due to cardiac catheterization | |
| Group 2 | Angiografic stenting Receives: Procedure: Retroperitoneal hematoma due to cardiac catheterization | |
| Group 3 | Surgery Receives: Procedure: Retroperitoneal hematoma due to cardiac catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: 01/01/2010- 31/10/2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2016 (estimated)
- Study startJan 2010
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment ProcedureStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ebubekir Gündeş, Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03006120
- Sponsor's protocol ID
- 2016.5/7-18
- Status last verified
- Dec 2016
- First submitted
- 28 Dec 2016
- Last updated
- 2 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Management and Factors Affecting Mortality in Retroperitoneal Hemorrhage Due to Cardiac Catheterization; Single Center Experience
- ClinicalTrials.gov ID
- NCT03006120
- Acronym / sponsor ID
- 2016.5/7-18
- Conditions
- Treatment Procedure, Mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Kartal Kosuyolu Yuksek Ihtisas Education and Research HospitalOther government
- Study start
- Jan 2010
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 30 Dec 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.
Bleeding complications after cardiac catheterization have been reviewed previously, but there are very few studies on retroperitoneal hematoma and appropriate treatment of patients is not well defined. For this reason, the investigators aimed to analyze the clinical manifestations of retroperitoneal hematomas in a single center using a case-control study design, to analyze the treatment procedure determinants and consequently to provide an updated and usable treatment algorithm.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Procedure: Retroperitoneal hematoma due to cardiac catheterizationConservative management |
| Group 2 | – | Procedure: Retroperitoneal hematoma due to cardiac catheterizationAngiografic stenting |
| Group 3 | – | Procedure: Retroperitoneal hematoma due to cardiac catheterizationSurgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Retroperitoneal hematoma following cardiac catheterization in our institution between January 2010 and October 2016.
Key inclusion criteria (1 listed)
- Retroperitoneal hematoma following cardiac catheterization
Key exclusion criteria (1 listed)
- Patients with retroperitoneal hematomas other than cardiac catheterization and patients with missing file records.
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 |
|---|---|---|
| Retroperitoneal hematoma due to cardiac catheterization | Procedure or surgery | Group 1, Group 2, Group 3 |
Primary outcome
Mortality
Time frame: 01/01/2010- 31/10/2016
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 2 Jan 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Treatment Procedure and Mortality, run by Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital.
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 1 inclusion and 1 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 2 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Mortality (time frame: 01/01/2010- 31/10/2016). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jan 2017.