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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03093857
Other study ID # 17-035
Secondary ID
Status Recruiting
Phase N/A
First received March 16, 2017
Last updated March 28, 2017
Start date June 1, 2014
Est. completion date December 31, 2018

Study information

Verified date March 2017
Source RWTH Aachen University
Contact Elena Hristodorova, MSc.
Phone 0241 80 35226
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 31, 2018
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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:

- 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

Study Design


Intervention

Diagnostic Test:
Determination of biomarker
Liquor, blood, and urine samples will be drawn and measured at different time points.

Locations

Country Name City State
Germany University Hospital RWTH Aachen Aachen NRW

Sponsors (1)

Lead Sponsor Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in neuropeptide P baseline and postoperative day 1 and postoperative day 2 and week 1
Primary Change in neuropeptide Y baseline and postoperative day 1 and postoperative day 2 and week 1
Primary Change in neurofilament triplet protein (NFL) baseline and postoperative day 1 and postoperative day 2 and week 1
Primary Change in S100B baseline and postoperative day 1 and postoperative day 2 and week 1
Primary Change in Glial fibrillary acidic protein (GFAp) baseline and postoperative day 1 and postoperative day 2 and week 1
Primary Change in lactate baseline and postoperative day 1 and postoperative day 2 and week 1
Primary Change in glucose baseline and postoperative day 1 and postoperative day 2 and week 1
Primary Change in oxygen baseline and postoperative day 1 and postoperative day 2 and week 1
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