Investigation of the Cerebrospinal Fluid and Further Tissue Samples for Biomarker Indicating Spinal Ischemia and Organ Failure in Patients With Thoracoabdominal Aortic Aneurysm (TAAA)

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.

Study Overview

• Status: Unknown
• Conditions: Thoracoabdominal Aortic Aneurysm
• Intervention / Treatment: Diagnostic test: Determination of biomarker

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Elena Hristodorova, MSc.; Phone Number: 0241 80 35226

Study Locations

• Germany
  • NRW
    • Aachen, NRW, Germany, 52074
      • Recruiting
      • University Hospital RWTH Aachen
      • Contact: Alexander GOmbert, Dr. med.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with thoracoabdominal aortic aneurysm

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in neuropeptide P	baseline and postoperative day 1 and postoperative day 2 and week 1
Change in neuropeptide Y	baseline and postoperative day 1 and postoperative day 2 and week 1
Change in neurofilament triplet protein (NFL)	baseline and postoperative day 1 and postoperative day 2 and week 1
Change in S100B	baseline and postoperative day 1 and postoperative day 2 and week 1
Change in Glial fibrillary acidic protein (GFAp)	baseline and postoperative day 1 and postoperative day 2 and week 1
Change in lactate	baseline and postoperative day 1 and postoperative day 2 and week 1
Change in glucose	baseline and postoperative day 1 and postoperative day 2 and week 1
Change in oxygen	baseline and postoperative day 1 and postoperative day 2 and week 1

Collaborators and Investigators

• Sponsor: RWTH Aachen University
• Investigators: Principal Investigator: Alexander Gombert, Dr. med., UK Aachen

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2014
• Primary Completion (Anticipated): December 31, 2018
• Study Completion (Anticipated): December 31, 2018

Study Registration Dates

• First Submitted: March 16, 2017
• First Submitted That Met QC Criteria: March 22, 2017
• First Posted (Actual): March 28, 2017

Study Record Updates

• Last Update Posted (Actual): March 29, 2017
• Last Update Submitted That Met QC Criteria: March 28, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Ischemia; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Thoracic
• Other Study ID Numbers: 17-035

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No