Aortic AneurysmODEANCT03136536
Organ Failure After Advanced Endovascular Thoracoabdominal Aortic Surgery
An observational study of Aortic Aneurysm and Spinal Ischaemia, run by Region Örebro County at 1 site in Sweden.
Trial summary
The purpose of this study is to investigate the mortality and frequency of organ dysfunction in patients after endovascular thoracoabdominal aortic surgery, and to search for biomarkers of organ dysfunction, in particular the spinal cord, the kidneys and the gastrointestinal tract. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Aneurysm, Spinal Ischaemia, Gastrointestinal Ischaemia
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- 3 May 2017to 31 Dec 2022
- 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: Adult patients undergoing endovascular advanced thoracoabdominal aortic surgical procedures at Örebro University Hospital, Örebro, Sweden.
Who may be able to join
- Accepted for endovascular advanced thoracoabdominal aortic surgical procedure
- Adult
Who cannot join
- Pregnant
Trial locations and contacts
1 site in 1 country.
Kristofer F Nilsson, MD, PhD contact
Sweden1 site, 1 recruiting
- Recruiting
Department of Cardio-thoracic and Vascular Surgery, Örebro University Hospital
Örebro
Kristofer F Nilsson, MD, PhD, 196020352 ext. +46, kristofer-bo-ingemar.nilsson@regionorebrolan.se
About this study
Official title: Kärlkirurgi Vid Komplicerade kroppspulsåderbråck - Utfall, Riskfaktorer Och sökande Efter biomarkörer för Organskada
The purpose of this study is to investigate the mortality and frequency of organ dysfunction in patients after endovascular thoracoabdominal aortic surgery, and to search for biomarkers of organ dysfunction, in particular the spinal cord, the kidneys and the gastrointestinal tract. All adult patients undergoing endovascular thoracoabdominal aortic surgery at Örebro University Hospital, Örebro, Sweden, are asked for participation in this study. All participating patients sign informed consent at the inclusion. During the operation and during the postoperative intensive care, the function of the spinal cord, the gastrointestinal tract and the kidneys are collected along with other clinical parameters. Plasma blood samples, urin samples and cerebrospinal fluid samples are collected from each patient during the operation and during the postoperative care at the intensive care unit. During the operation two microdialysis catheters are placed in the abdomen, and the samples are continuously collected and analyzed. The biomaterial samples are stored in a biobank for later determination of proteins and other molecules. Postoperative survival and the frequency of complications are analysed.
- Medical subject headings
- Aortic Aneurysm
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Overall and aortic-related mortality
Measured: 1 year postoperative
Secondary outcomes (1)
Organ dysfunction and failure
Spinal cord, gastrointestinal tract, kidneys
Measured: Postoperative: 7 days, 30 days, 1 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study start3 May 2017
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic AneurysmStudies 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
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristofer F Nilsson, MD, PhD, Principal investigator, Department of Cardio-thoracic and Vascular Surgery, Faculty of Medicine and Health, Örebro University, Örebro, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03136536
- Sponsor's protocol ID
- 206471
- Acronym
- ODEA
- Status last verified
- Mar 2021
- First submitted
- 19 Apr 2017
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- 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 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kärlkirurgi Vid Komplicerade kroppspulsåderbråck - Utfall, Riskfaktorer Och sökande Efter biomarkörer för Organskada
- ClinicalTrials.gov ID
- NCT03136536
- Acronym / sponsor ID
- ODEA / 206471
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Study start
- 3 May 2017 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 2 May 2017 (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.
The purpose of this study is to investigate the mortality and frequency of organ dysfunction in patients after endovascular thoracoabdominal aortic surgery, and to search for biomarkers of organ dysfunction, in particular the spinal cord, the kidneys and the gastrointestinal tract. All adult patients undergoing endovascular thoracoabdominal aortic surgery at Örebro University Hospital, Örebro, Sweden, are asked for participation in this study. All participating patients sign informed consent at the inclusion. During the operation and during the postoperative intensive care, the function of the spinal cord, the gastrointestinal tract and the kidneys are collected along with other clinical parameters. Plasma blood samples, urin samples and cerebrospinal fluid samples are collected from each patient during the operation and during the postoperative care at the intensive care unit. During the operation two microdialysis catheters are placed in the abdomen, and the samples are continuously collected and analyzed. The biomaterial samples are stored in a biobank for later determination of proteins and other molecules. Postoperative survival and the frequency of complications are analysed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing endovascular advanced thoracoabdominal aortic surgical procedures at Örebro University Hospital, Örebro, Sweden.
Key inclusion criteria (2 listed)
- Accepted for endovascular advanced thoracoabdominal aortic surgical procedure
- Adult
Key exclusion criteria (1 listed)
- Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality
Time frame: 1 year postoperative
Overall and aortic-related mortality
1 secondary outcome
Organ dysfunction and failure
Time frame: Postoperative: 7 days, 30 days, 1 year follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- 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.
Kristofer F Nilsson, MD, PhD contact
Kristofer F Nilsson, MD, PhD principal investigator
Department of Cardio-thoracic and Vascular Surgery, Faculty of Medicine and Health, Örebro University, Örebro, Sweden
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 Aortic Aneurysm and Spinal Ischaemia, run by Region Örebro County at 1 site in Sweden.
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 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: status not confirmed, as of the sponsor's last update on 10 Mar 2021. 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 Sweden. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kristofer F Nilsson, MD, PhD (196020352 ext. +46, kristofer-bo-ingemar.nilsson@regionorebrolan.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 1 year postoperative). 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 10 Mar 2021.