Child HealthNCT04455373
Long-term Outcome in Pediatric Surgical Bypass Grafting After Traumatic Injury and Tumor Resection
An observational study of Child Health and Bypass Graft Occlusion, run by Medical University of Vienna.
Trial summary
Introduction: Vascular bypass surgery in children differs significantly from adults. It is a rarely performed procedure in the setting of trauma and tumor surgery to facilitate limb salvage. Read more about this study
- Who is it for?
- Ages 2 months to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Health, Bypass Graft Occlusion
- What is being tested?
- pediatric vascular bypass grafting
- Type of treatment
- Surgery or procedure
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2002to 1 Feb 2020
- 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 2 months to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: This study represents a retrospective cohort analysis of pediatric patients who underwent vascular bypass grafting by an experienced team of vascular surgeons at the Medical University Vienna between 2002-2017. All data regarding demographics, operative techniques and outcome were collected from the in-hospital database registry in collaboration with the Department of Orthopedics and Trauma-Surgery. All patients ≤ 18 years who suffered a traumatic injury or vascular surgery due to a planned orthopedic extremity tumor resection were included in this study. 33 patients underwent vascular repair, a total of 15 patients fulfilling the criteria could be identified.
Who may be able to join
- age <18 years
- planned vascular bypass grafting
Who cannot join
- age >18 years
- no vascular intervention
About this study
Introduction:
Vascular bypass surgery in children differs significantly from adults. It is a rarely performed procedure in the setting of trauma and tumor surgery to facilitate limb salvage. Beside the technical challenges to reconstruct the small and spastic vessels, bypass grafting should not impede growth of the extremity. The primary aim of this study was to assess long-term outcome after pediatric bypass grafting, in a single academic center, focusing on potential effects on limb development.
Read more
Methods:
In this retrospective cohort analyses we included all pediatric patients undergoing vascular bypass grafting at the Medical University of Vienna between 2002-2017. All patients ≤ 18 years suffered a traumatic injury or underwent a tumor resection of the lower or upper limb, respectively. The youngest female patient was 0.4 years, the youngest male patient was 3.5 years.
- Conditions
- Child Health, Bypass Graft Occlusion
- Being tested
- pediatric vascular bypass grafting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pediatric vascular bypass graftingProcedure or surgery
pediatric vascular bypass grafting
| Study group | Role | What they receive |
|---|---|---|
| orthopedic surgery group | Planned tumor resection Receives: Procedure: pediatric vascular bypass grafting | |
| traumatic surgery group | Patients with traumatic vascular injury Receives: Procedure: pediatric vascular bypass grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
bypass growth
bypass growth
Measured: 10 years
Secondary outcomes (2)
autologous vs. PTFE graft
patients will either receive an autologous bypass graft or PTFE graft
Measured: patency rate in 1 year
revision surgery
revision surgery
Measured: <30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start1 Jan 2002
- Primary completion30 Jan 2017
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child HealthStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephanie Kampf, MD, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04455373
- Sponsor's protocol ID
- 1025/2018
- Status last verified
- Jun 2020
- First submitted
- 23 Jun 2020
- Last updated
- 2 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Outcome in Pediatric Surgical Bypass Grafting After Traumatic Injury and Tumor Resection
- ClinicalTrials.gov ID
- NCT04455373
- Acronym / sponsor ID
- 1025/2018
- Conditions
- Child Health, Bypass Graft Occlusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Jan 2002 (actual)
- Primary completion
- 30 Jan 2017 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 2 Jul 2020 (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.
Introduction:
Vascular bypass surgery in children differs significantly from adults. It is a rarely performed procedure in the setting of trauma and tumor surgery to facilitate limb salvage. Beside the technical challenges to reconstruct the small and spastic vessels, bypass grafting should not impede growth of the extremity. The primary aim of this study was to assess long-term outcome after pediatric bypass grafting, in a single academic center, focusing on potential effects on limb development.
Methods:
In this retrospective cohort analyses we included all pediatric patients undergoing vascular bypass grafting at the Medical University of Vienna between 2002-2017. All patients ≤ 18 years suffered a traumatic injury or underwent a tumor resection of the lower or upper limb, respectively. The youngest female patient was 0.4 years, the youngest male patient was 3.5 years.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| orthopedic surgery group | – | Procedure: pediatric vascular bypass graftingPlanned tumor resection |
| traumatic surgery group | – | Procedure: pediatric vascular bypass graftingPatients with traumatic vascular injury |
Who may qualify
- Ages
- 2 months to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- This study represents a retrospective cohort analysis of pediatric patients who underwent vascular bypass grafting by an experienced team of vascular surgeons at the Medical University Vienna between 2002-2017. All data regarding demographics, operative techniques and outcome were collected from the in-hospital database registry in collaboration with the Department of Orthopedics and Trauma-Surgery. All patients ≤ 18 years who suffered a traumatic injury or vascular surgery due to a planned orthopedic extremity tumor resection were included in this study. 33 patients underwent vascular repair, a total of 15 patients fulfilling the criteria could be identified.
Key inclusion criteria (2 listed)
- age <18 years
- planned vascular bypass grafting
Key exclusion criteria (2 listed)
- age >18 years
- no vascular intervention
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 |
|---|---|---|
| pediatric vascular bypass graftingpediatric vascular bypass grafting | Procedure or surgery | orthopedic surgery group, traumatic surgery group |
Primary outcome
bypass growth
Time frame: 10 years
bypass growth
2 secondary outcomes
autologous vs. PTFE graft
Time frame: patency rate in 1 year
revision surgery
Time frame: <30 days
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 Jul 2020.
- Individual participant dataSharing planned: No
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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 Child Health and Bypass Graft Occlusion, run by Medical University of Vienna.
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: finished, as of the sponsor's last update on 2 Jul 2020. 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?
bypass growth (time frame: 10 years). 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 Jul 2020.