Cytokine Filter Usage During Open Thoracoabdominal Aortic Aneurysm Repair- a Single-center Randomized Prospective Trial

NCT04765748 | Completed

• 1 other identifier: 20-031
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Prospecrtive study including 20-30 randomized patients treated by open repair because of an TAAA larger than 55 mm During the surgery, a heart lung machine is applied for distal perfusion during aortic cross clamping to enable distal organ perfusion. Regardless an intensive inflammatory reaction is a well known effect after reperfusion, leading to a uncontrolled inflammation during th first days after surgery. This may be associated to bad outcome and decreased survival rates. By the application of a intraoperative cytokine and DAMP filter this negative ffect could be reduced, resulting in a better outcome after surgery.

Conditions

Postoperative Complications; Inflammatory Response

Outcome Measures

Primary Outcomes (2)

• Amount of perioperative catecholamine usage in mg/dl for the first seven days after surgery

  amount measured in mg/dl

  7 days perioperatively -10 day postoperatively

• Amount of transfusion required during and after the surgery, assessed in transfusion more or less than 5 blood bags

  packed cells, erythrocyte concentrate

  7 days perioperatively 5-10 day postoperatively

Secondary Outcomes (2)

• Acute kidney injury, measured using serum creatinine in mg/dl

  7 days perioperatively, -10 day postoperatively

• Patients survival for the first 12 months after surgery

  12 months 10-14 months postopertaibely

Study Arms (2)

TAAA patients with Cytosorb

Patients suffering from a TAAA larger than 55mm

Device: Cytosorb

TAAA patients without Cytosorb

Patients suffering from a TAAA larger than 55mm

Interventions

Cytosorb DEVICE

Cytokine filter, which can be used intraoperatively while using a heart lung machine

TAAA patients with Cytosorb

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients treated by open TAAA repair

You may qualify if:

• Suffering from a TAAA larger than 55mm

You may not qualify if:

• immunosupprive therapy pregnancy

Sponsors & Collaborators

• RWTH Aachen University: lead

Study Sites (1)

Alexander Gombert

Aachen, North Rhine-Westphalia, 52074, Germany

Location

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator PD Dr. med. Alexander Gombert, Specialist in Vascular Surgery

Study Record Dates

• First Submitted: February 17, 2021
• First Posted: February 21, 2021
• Study Start: February 11, 2021
• Primary Completion: November 27, 2022
• Study Completion: December 27, 2022
• Last Updated: April 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)