Vascular DiseasesNCT05433623
Vascular Surgery Admissions in a Tertiary Care Hospital in the Mid-West: A 12 Month Profile.
An observational study of Vascular Diseases, run by University Hospital of Limerick.
Trial summary
Creating a 12 month profile of Vascular Surgery Admissions aims to inform service delivery and optimise patient care resources. There is a gap in the literature pertaining to this topic, particularly from an Irish perspective. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Diseases
- What is being tested?
- Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2025to 15 Sep 2025
- 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
- Adult, Older adult
Study population: This study aims to create a profile f vascular admissions to a tertiary care hospital in the Mid West of Ireland and describe the characteristics of the admission.
Who may be able to join
- Patients attending UHL deemed to have vascular care needs and assigned to the care of a Vascular Consultant will be included in this study.
- The data will be collected 12 months from the date of commencing the study.
Who cannot join
- Patients outside of the set dates will be excluded.
- Vascular consults will be excluded for the purpose of this research unless care is transferred.
About this study
Creating a 12 month profile of Vascular Surgery Admissions aims to inform service delivery and optimise patient care resources. There is a gap in the literature pertaining to this topic, particularly from an Irish perspective. This research could inform a clinical pathway to reduce LOS for patients cared for by the Department of Vascular Surgery.
Read the detailed description
This is an observational cross sectional study. This study will be mixed methods. Following the profile creation the researcher aims to complete qualitative research in the form of interviewing a cohort of vascular patients about their experiences in order to inform practice development. Ethics approval will be granted prior to any activities taking place.
Selection/Recruitment:
Patients attending UHL deemed to have vascular care needs and assigned to the care of a Vascular Consultant will be included in this study. The data will be collected 12 months from the date of commencing the study. Vascular consults will be excluded for the purpose for this research unless care is transferred. Informed consent is not required for this research so there in no exclusion criteria in relation to ability to provide same.
Data Collection:
The data to inform this project will be collected from medical chart review and utilising the UHL inpatient IT systems. No patient identifiers will be collected for this research and it will comply with GDPR. The Ipims system will be used to measure current inpatients under the care of a Vascular Consultant. HIPE data will be requested to examine the length of stay for vascular inpatients. The individual's medical notes will be reviewed to assess:
- Reason for admission to hospital and/or presentation to the Emergency Department (ED).
- Date, day and time of admission.
- Referral source.
- Categorisation from triage in the ED if applicable.
- Consultant caring for the individual.
- Demographic profile \& Brief Medical and Surgical History.
- ? Elective or Emergency admission.
- ? Intervention or conservative management. Treatment course.
- ? Re-admission.
- Length of stay.
- Time patient waited for theatre procedure (date of admission to date of theatre) including fasting time.
- Time patient waited for vascular scans (date of admission to date of scans) \& scans completed.
- Time patient waited for rehab (transfer) if applicable.
- Time patient waited for OPAT if applicable.
- Clinical Frailty Scale (Appendix II) \& Charlson Co-Morbidity Scale (Appendix III) (no patient intervention required).
Data Analysis:
Descriptive statistics with multivariant analyses.
Process Evaluation:
The MRC Framework will be employed for process evaluation.
- Conditions
- Vascular Diseases
- Being tested
- Surgery
- Medical subject headings
- Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
It will be documented if the patient underwent surgery for their vascular issue
| Study group | Role | What they receive |
|---|---|---|
| Vascular Surgery Admissions | Patients who present and/or are admitted to University Hospital Limerick under the care of a Vascular Consultant. Receives: Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Frailty Scale
Clinical frailty score will be determined for vascular patient admissions. This is a 9 point scale. the higher the score means the greater the risk.
Measured: 1 year
Charlson Co-Morbidity Scale
Scoring will be determined for vascular patient admissions. The Charlson Comorbidity Index (CCI) assesses comorbidity level by taking into account both the number and severity of 19 pre-defined comorbid conditions. It provides a weighted score of a client's comorbidities which can be used to predict short term and long-term outcomes such as function, hospital length of stay and mortality rates.
Measured: 1 year
Admission details
Length of stay, interventions, referral source will be documented
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start15 Sep 2025 (estimated)
- Primary completion15 Sep 2025 (estimated)
- Study completion15 Sep 2025 (estimated)
Why it stopped: Insufficient resources to complete this project.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular DiseasesStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Limerick
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fiona Leahy, University Hospital of Limerick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05433623
- Sponsor's protocol ID
- DVS001
- Status last verified
- Sep 2025
- First submitted
- 1 Jun 2022
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The researcher will not be sharing IPD
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Surgery Admissions in a Tertiary Care Hospital in the Mid-West: A 12 Month Profile.
- ClinicalTrials.gov ID
- NCT05433623
- Acronym / sponsor ID
- DVS001
- Conditions
- Vascular Diseases
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Insufficient resources to complete this project.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital of LimerickUniversity, hospital or other
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 15 Sep 2025 (estimated)
- Study completion
- 15 Sep 2025 (estimated)
- First posted
- 27 Jun 2022 (actual)
- 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.
Creating a 12 month profile of Vascular Surgery Admissions aims to inform service delivery and optimise patient care resources. There is a gap in the literature pertaining to this topic, particularly from an Irish perspective. This research could inform a clinical pathway to reduce LOS for patients cared for by the Department of Vascular Surgery.
Detailed description
This is an observational cross sectional study. This study will be mixed methods. Following the profile creation the researcher aims to complete qualitative research in the form of interviewing a cohort of vascular patients about their experiences in order to inform practice development. Ethics approval will be granted prior to any activities taking place.
Selection/Recruitment:
Patients attending UHL deemed to have vascular care needs and assigned to the care of a Vascular Consultant will be included in this study. The data will be collected 12 months from the date of commencing the study. Vascular consults will be excluded for the purpose for this research unless care is transferred. Informed consent is not required for this research so there in no exclusion criteria in relation to ability to provide same.
Data Collection:
The data to inform this project will be collected from medical chart review and utilising the UHL inpatient IT systems. No patient identifiers will be collected for this research and it will comply with GDPR. The Ipims system will be used to measure current inpatients under the care of a Vascular Consultant. HIPE data will be requested to examine the length of stay for vascular inpatients. The individual's medical notes will be reviewed to assess:
- Reason for admission to hospital and/or presentation to the Emergency Department (ED).
- Date, day and time of admission.
- Referral source.
- Categorisation from triage in the ED if applicable.
- Consultant caring for the individual.
- Demographic profile \& Brief Medical and Surgical History.
- ? Elective or Emergency admission.
- ? Intervention or conservative management. Treatment course.
- ? Re-admission.
- Length of stay.
- Time patient waited for theatre procedure (date of admission to date of theatre) including fasting time.
- Time patient waited for vascular scans (date of admission to date of scans) \& scans completed.
- Time patient waited for rehab (transfer) if applicable.
- Time patient waited for OPAT if applicable.
- Clinical Frailty Scale (Appendix II) \& Charlson Co-Morbidity Scale (Appendix III) (no patient intervention required).
Data Analysis:
Descriptive statistics with multivariant analyses.
Process Evaluation:
The MRC Framework will be employed for process evaluation.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vascular Surgery Admissions | – | Procedure: SurgeryPatients who present and/or are admitted to University Hospital Limerick under the care of a Vascular Consultant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This study aims to create a profile f vascular admissions to a tertiary care hospital in the Mid West of Ireland and describe the characteristics of the admission.
Key inclusion criteria (2 listed)
- Patients attending UHL deemed to have vascular care needs and assigned to the care of a Vascular Consultant will be included in this study.
- The data will be collected 12 months from the date of commencing the study.
Key exclusion criteria (2 listed)
- Patients outside of the set dates will be excluded.
- Vascular consults will be excluded for the purpose of this research unless care is transferred.
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 |
|---|---|---|
| SurgeryIt will be documented if the patient underwent surgery for their vascular issue | Procedure or surgery | Vascular Surgery Admissions |
Primary outcome
Clinical Frailty Scale
Time frame: 1 year
Clinical frailty score will be determined for vascular patient admissions. This is a 9 point scale. the higher the score means the greater the risk.
Charlson Co-Morbidity Scale
Time frame: 1 year
Scoring will be determined for vascular patient admissions. The Charlson Comorbidity Index (CCI) assesses comorbidity level by taking into account both the number and severity of 19 pre-defined comorbid conditions. It provides a weighted score of a client's comorbidities which can be used to predict short term and long-term outcomes such as function, hospital length of stay and mortality rates.
Admission details
Time frame: 1 year
Length of stay, interventions, referral source will be documented
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Individual participant dataSharing planned: No. The researcher will not be sharing IPD
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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 Vascular Diseases, run by University Hospital of Limerick.
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 2 inclusion and 2 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: withdrawn, as of the sponsor's last update on 18 Sep 2025. 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 was withdrawn before enrolling participants, so there are no results.
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?
Clinical Frailty Scale (time frame: 1 year). The study lists 3 primary outcomes in all. 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 18 Sep 2025.