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

NCT ID: NCT03093857

Last Updated: 2017-03-29

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-06-01
• Study Completion Date: 2018-12-31

Brief 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.

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.

Conditions

Thoracoabdominal Aortic Aneurysm

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

Determination of biomarker

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RWTH Aachen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexander Gombert, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

UK Aachen

Locations

University Hospital RWTH Aachen

Aachen, North Rhine-Westphalia, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Elena Hristodorova, MSc.

Role: CONTACT

0241 80 35226

Facility Contacts

Alexander GOmbert, Dr. med.

Role: primary

Other Identifiers

17-035

Identifier Type: -

Identifier Source: org_study_id