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Status unknownNCT03093857TAAAUpdated Mar 29, 2017

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 in Thoracoabdominal Aortic Aneurysm, sponsored by RWTH Aachen University. Status unknown at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-29.

Sponsored by RWTH Aachen University · Observational

The sponsor has not verified this record recently (last verified Mar 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
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Study 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. 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.

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Conditions studied

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In context

Aneurysm

960 studies on the registry are indexed under Aneurysm; 175 are open to participants now.

This study's planned enrollment of 100 is below the median of 151 across 443 observational studies indexed under Aneurysm.

Browse Aneurysm studies →

Lead sponsor

RWTH Aachen University is the lead sponsor of 228 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with thoracoabdominal aortic aneurysm

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testDetermination of biomarker

    Liquor, blood, and urine samples will be drawn and measured at different time points.

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What researchers measure

Primary outcomes

  1. Change in neuropeptide P

    Time frame: baseline and postoperative day 1 and postoperative day 2 and week 1

  2. Change in neuropeptide Y

    Time frame: baseline and postoperative day 1 and postoperative day 2 and week 1

  3. Change in neurofilament triplet protein (NFL)

    Time frame: baseline and postoperative day 1 and postoperative day 2 and week 1

  4. Change in S100B

    Time frame: baseline and postoperative day 1 and postoperative day 2 and week 1

  5. Change in Glial fibrillary acidic protein (GFAp)

    Time frame: baseline and postoperative day 1 and postoperative day 2 and week 1

  6. Change in lactate

    Time frame: baseline and postoperative day 1 and postoperative day 2 and week 1

  7. Change in glucose

    Time frame: baseline and postoperative day 1 and postoperative day 2 and week 1

  8. Change in oxygen

    Time frame: baseline and postoperative day 1 and postoperative day 2 and week 1

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Study locations

1 of 1 sites recruiting
  • University Hospital RWTH Aachen
    Aachen, NRW 52074, Germany
    • Alexander GOmbert, Dr. med. · Contact
    Recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 29, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03093857
Lead sponsor
RWTH Aachen University
Responsible party
Sponsor
First posted
Mar 28, 2017
Start date
Jun 1, 2014
Primary completion
Dec 31, 2018 (estimated)
Completion
Dec 31, 2018 (estimated)
Last update
Mar 29, 2017

Study contacts

Elena Hristodorova, MSc.
Contact
0241 80 35226
Alexander Gombert, Dr. med.
principal investigator · UK Aachen

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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