Thoracoabdominal Aortic Aneurysm Clinical Trial
— TAAAOfficial title:
Investigation of the Cerebrospinal Fluid and Further Tissue Samples for Biomarker Indicating Spinal Ischemia and Organ Failure in Patients With Thoracoabdominal Aortic Aneurysm
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 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Germany | University Hospital RWTH Aachen | Aachen | NRW |
Lead Sponsor | Collaborator |
---|---|
RWTH Aachen University |
Germany,
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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