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

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ClinicalTrials.gov Identifier: NCT03093857
Recruitment Status : Unknown
Verified March 2017 by RWTH Aachen University.
Recruitment status was:  Recruiting
First Posted : March 28, 2017
Last Update Posted : March 29, 2017
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University

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.

Condition or disease Intervention/treatment
Thoracoabdominal Aortic Aneurysm 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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Investigation of the Cerebrospinal Fluid and Further Tissue Samples for Biomarker Indicating Spinal Ischemia and Organ Failure in Patients With Thoracoabdominal Aortic Aneurysm
Actual Study Start Date : June 1, 2014
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine



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


Primary Outcome Measures :
  1. Change in neuropeptide P [ Time Frame: baseline and postoperative day 1 and postoperative day 2 and week 1 ]
  2. Change in neuropeptide Y [ Time Frame: baseline and postoperative day 1 and postoperative day 2 and week 1 ]
  3. Change in neurofilament triplet protein (NFL) [ Time Frame: baseline and postoperative day 1 and postoperative day 2 and week 1 ]
  4. Change in S100B [ Time Frame: baseline and postoperative day 1 and postoperative day 2 and week 1 ]
  5. Change in Glial fibrillary acidic protein (GFAp) [ Time Frame: baseline and postoperative day 1 and postoperative day 2 and week 1 ]
  6. Change in lactate [ Time Frame: baseline and postoperative day 1 and postoperative day 2 and week 1 ]
  7. Change in glucose [ Time Frame: baseline and postoperative day 1 and postoperative day 2 and week 1 ]
  8. Change in oxygen [ Time Frame: baseline and postoperative day 1 and postoperative day 2 and week 1 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with thoracoabdominal aortic aneurysm
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03093857


Contacts
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Contact: Elena Hristodorova, MSc. 0241 80 35226

Locations
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Germany
University Hospital RWTH Aachen Recruiting
Aachen, NRW, Germany, 52074
Contact: Alexander GOmbert, Dr. med.         
Sponsors and Collaborators
RWTH Aachen University
Investigators
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Principal Investigator: Alexander Gombert, Dr. med. UK Aachen
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Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT03093857    
Other Study ID Numbers: 17-035
First Posted: March 28, 2017    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Thoracic
Ischemia
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases