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
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.
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.
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 →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.
Patients with thoracoabdominal aortic aneurysm
Exclusion Criteria:
Liquor, blood, and urine samples will be drawn and measured at different time points.
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
Plan to share: Undecided
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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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RWTH Aachen University