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

NCT ID: NCT04765748

Last Updated: 2024-04-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-11
• Study Completion Date: 2022-12-27

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.

Detailed Description

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

Study Design

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

Study Groups

TAAA patients with Cytosorb

Patients suffering from a TAAA larger than 55mm

Cytosorb

Intervention Type: DEVICE

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

TAAA patients without Cytosorb

Patients suffering from a TAAA larger than 55mm

No interventions assigned to this group

Interventions

Cytosorb

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

Suffering from a TAAA larger than 55mm

Exclusion Criteria

immunosupprive therapy pregnancy

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RWTH Aachen University

OTHER

Sponsor Role: lead

Responsible Party

Alexander Gombert

Principle Investigator PD Dr. med. Alexander Gombert, Specialist in Vascular Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Alexander Gombert

Aachen, North Rhine-Westphalia, Germany

Countries

Germany

Other Identifiers

20-031

Identifier Type: -

Identifier Source: org_study_id