Thoracoabdominal Aortic AneurysmTAAANCT03093857
Investigation of the Cerebrospinal Fluid and Further Tissue Samples for Biomarker Indicating Spinal Ischemia and Organ Failure in Patients With Thoracoabdominal Aortic Aneurysm
An observational study of Thoracoabdominal Aortic Aneurysm, run by RWTH Aachen University at 1 site in Germany.
Trial summary
Patients with a thoracoabdominal aortic aneurysm in need of an endovascular or open operative restructuring will be asked to participate in this study. After obtaining written consent a central venous catheter and a liquor drainage will be routinely placed during surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracoabdominal Aortic Aneurysm
- What is being tested?
- Determination of biomarker
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2014to 31 Dec 2018
- 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: Patients with thoracoabdominal aortic aneurysm
Who may be able to join
- presence of thoracoabdominal aortic aneurysm
- endovascular or open operative restructuring
- age>18 years
- given written consent
- subjects, who are mentally and legally capable to understand the scope of the trial and comply with the protocol
Who cannot join
- local skin infection (cutaneous fungus, acne)
- pregnant or lactating females
- parallel participation in another clinical trial
- incarcerated subjects
- subjects, who are in an interdependency with the sponsor or investigator
Trial locations and contacts
1 site in 1 country.
Elena Hristodorova, MSc. contact
Germany1 site, 1 recruiting
- Recruiting
University Hospital RWTH Aachen
Aachen, North Rhine-Westphalia, 52074
Alexander GOmbert, Dr. med.
About this study
Patients with a thoracoabdominal aortic aneurysm in need of an endovascular or open operative restructuring will be asked to participate in this study. After obtaining written consent a central venous catheter and a liquor drainage will be routinely placed during surgery. The catheter and the drainage will stay in the patients for at least 72 hours postoperatively. In total, nine measurements of the liquor and serum will be performed within a week in order to determine the following parameters: neuropeptide P, neuropeptide Y, neurofilament triplet protein (NFL), S100B, glial fibrillary protein (GFAp), lactate, glucose, or oxygen.
Read the detailed description
Patients with complex aortic diseases receiving an operative treatment are under risk of spinal cord damage due to insufficient blood circulation of the spinal cord during surgery. The risk depends on comorbidities, extent of surgery, and the perioperative management. Despite an adequate preoperative imaging, assessment of the blood circulation of the spinal cord during endovascular or open operative restructuring is struggling. Beside the monitoring possibilities of the spinal cord functions during surgery, insufficient approaches regarding early detection of spinal ischemia by using laboratory parameters exist. Several biomarker, e.g. neuropeptide P, neuropeptide Y, neurofilament triplet protein (NFL), S100B, glial fibrillary protein (GFAp), lactate, glucose, or oxygen, will be evaluated singularly or as a bundle of markers in small patient groups. Surgeries of thoracoabdominal aortic aneurysms are associated with high risks despite already existing high standardized procedures (Cowan et al. 2003). The major complications are cardiovascular, renal, pulmonary, gastrointestinal complications, and ischemias of the spinal cord. Especially, the ischemia of the spinal cord is a feared complication caused by the irreversibility and the small time frame.
During the study samples of liquor and tissues (serum, urine) will be drawn pre-, peri- and postoperatively. Patients will receive a routinely placed liquor drainage due to the temporal duration in surgery. The liquor drainage stays in the patient also in the early postoperative phase. Hence, the patient will not be bothered with additional examinations. Additionally, biomaterial (blood) will be drawn routinely and used for the biomarker measurement as well as biobanking.
- Conditions
- Thoracoabdominal Aortic Aneurysm
- Being tested
- Determination of biomarker
- Medical subject headings
- Aortic Aneurysm, Thoracoabdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Determination of biomarkerDiagnostic test
Liquor, blood, and urine samples will be drawn and measured at different time points.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in neuropeptide P
Measured: baseline and postoperative day 1 and postoperative day 2 and week 1
Change in neuropeptide Y
Measured: baseline and postoperative day 1 and postoperative day 2 and week 1
Change in neurofilament triplet protein (NFL)
Measured: baseline and postoperative day 1 and postoperative day 2 and week 1
Change in S100B
Measured: baseline and postoperative day 1 and postoperative day 2 and week 1
Change in Glial fibrillary acidic protein (GFAp)
Measured: baseline and postoperative day 1 and postoperative day 2 and week 1
Change in lactate
Measured: baseline and postoperative day 1 and postoperative day 2 and week 1
Change in glucose
Measured: baseline and postoperative day 1 and postoperative day 2 and week 1
Change in oxygen
Measured: baseline and postoperative day 1 and postoperative day 2 and week 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2017
- Study start1 Jun 2014
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracoabdominal 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
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander Gombert, Dr. med., Principal investigator, UK Aachen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03093857
- Sponsor's protocol ID
- 17-035
- Acronym
- TAAA
- Status last verified
- Mar 2017
- First submitted
- 16 Mar 2017
- Last updated
- 29 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Cerebrospinal Fluid and Further Tissue Samples for Biomarker Indicating Spinal Ischemia and Organ Failure in Patients With Thoracoabdominal Aortic Aneurysm
- ClinicalTrials.gov ID
- NCT03093857
- Acronym / sponsor ID
- TAAA / 17-035
- Conditions
- Thoracoabdominal Aortic Aneurysm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- 1 Jun 2014 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 28 Mar 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.
Patients with a thoracoabdominal aortic aneurysm in need of an endovascular or open operative restructuring will be asked to participate in this study. After obtaining written consent a central venous catheter and a liquor drainage will be routinely placed during surgery. The catheter and the drainage will stay in the patients for at least 72 hours postoperatively. In total, nine measurements of the liquor and serum will be performed within a week in order to determine the following parameters: neuropeptide P, neuropeptide Y, neurofilament triplet protein (NFL), S100B, glial fibrillary protein (GFAp), lactate, glucose, or oxygen.
Detailed description
Patients with complex aortic diseases receiving an operative treatment are under risk of spinal cord damage due to insufficient blood circulation of the spinal cord during surgery. The risk depends on comorbidities, extent of surgery, and the perioperative management. Despite an adequate preoperative imaging, assessment of the blood circulation of the spinal cord during endovascular or open operative restructuring is struggling. Beside the monitoring possibilities of the spinal cord functions during surgery, insufficient approaches regarding early detection of spinal ischemia by using laboratory parameters exist. Several biomarker, e.g. neuropeptide P, neuropeptide Y, neurofilament triplet protein (NFL), S100B, glial fibrillary protein (GFAp), lactate, glucose, or oxygen, will be evaluated singularly or as a bundle of markers in small patient groups. Surgeries of thoracoabdominal aortic aneurysms are associated with high risks despite already existing high standardized procedures (Cowan et al. 2003). The major complications are cardiovascular, renal, pulmonary, gastrointestinal complications, and ischemias of the spinal cord. Especially, the ischemia of the spinal cord is a feared complication caused by the irreversibility and the small time frame.
During the study samples of liquor and tissues (serum, urine) will be drawn pre-, peri- and postoperatively. Patients will receive a routinely placed liquor drainage due to the temporal duration in surgery. The liquor drainage stays in the patient also in the early postoperative phase. Hence, the patient will not be bothered with additional examinations. Additionally, biomaterial (blood) will be drawn routinely and used for the biomarker measurement as well as biobanking.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with thoracoabdominal aortic aneurysm
Key inclusion criteria (5 listed)
- presence of thoracoabdominal aortic aneurysm
- endovascular or open operative restructuring
- age>18 years
- given written consent
- subjects, who are mentally and legally capable to understand the scope of the trial and comply with the protocol
Key exclusion criteria (5 listed)
- local skin infection (cutaneous fungus, acne)
- pregnant or lactating females
- parallel participation in another clinical trial
- incarcerated subjects
- subjects, who are in an interdependency with the sponsor or investigator
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 |
|---|---|---|
| Determination of biomarkerLiquor, blood, and urine samples will be drawn and measured at different time points. | Diagnostic test | – |
Primary outcome
Change in neuropeptide P
Time frame: baseline and postoperative day 1 and postoperative day 2 and week 1
Change in neuropeptide Y
Time frame: baseline and postoperative day 1 and postoperative day 2 and week 1
Change in neurofilament triplet protein (NFL)
Time frame: baseline and postoperative day 1 and postoperative day 2 and week 1
Change in S100B
Time frame: baseline and postoperative day 1 and postoperative day 2 and week 1
Change in Glial fibrillary acidic protein (GFAp)
Time frame: baseline and postoperative day 1 and postoperative day 2 and week 1
Change in lactate
Time frame: baseline and postoperative day 1 and postoperative day 2 and week 1
Change in glucose
Time frame: baseline and postoperative day 1 and postoperative day 2 and week 1
Change in oxygen
Time frame: baseline and postoperative day 1 and postoperative day 2 and week 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
- 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.
Elena Hristodorova, MSc. contact
Alexander Gombert, Dr. med. principal investigator
UK Aachen
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 Thoracoabdominal Aortic Aneurysm, run by RWTH Aachen University at 1 site in Germany.
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 5 inclusion and 5 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 29 Mar 2017. 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 Germany. 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 Elena Hristodorova, MSc. (0241 80 35226), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in neuropeptide P (time frame: baseline and postoperative day 1 and postoperative day 2 and week 1). The study lists 8 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 29 Mar 2017.