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

Overview

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.

Full Title of Study: “Cytokine Filter Usage During Open Thoracoabdominal Aortic Aneurysm Repair- a Single-center Randomized Prospective Trial- Cytosorb and Its Imapct on Open TAAA Repair Outcome”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: February 27, 2022

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.

Interventions

  • Device: Cytosorb
    • Cytokine filter, which can be used intraoperatively while using a heart lung machine

Arms, Groups and Cohorts

  • TAAA patients with Cytosorb
    • Patients suffering from a TAAA larger than 55mm
  • TAAA patients without Cytosorb
    • Patients suffering from a TAAA larger than 55mm

Clinical Trial Outcome Measures

Primary Measures

  • Amount of perioperative catecholamine usage in mg/dl for the first seven days after surgery
    • Time Frame: 7 days perioperatively
    • amount measured in mg/dl
  • Amount of transfusion required during and after the surgery, assessed in transfusion more or less than 5 blood bags
    • Time Frame: 7 days perioperatively
    • packed cells, erythrocyte concentrate

Secondary Measures

  • Acute kidney injury, measured using serum creatinine in mg/dl
    • Time Frame: 7 days perioperatively
    • AKI assessed according to the KDIGO classification perioperatively for the first 7 days after surgery
  • Patients survival for the first 12 months after surgery
    • Time Frame: 12 months
    • Survival yes/no within the first 12 months after surgery

Participating in This Clinical Trial

Inclusion Criteria

Suffering from a TAAA larger than 55mm Exclusion Criteria:

immunosupprive therapy pregnancy -

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Investigator Details

  • Lead Sponsor
    • RWTH Aachen University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Alexander Gombert, Principle Investigator PD Dr. med. Alexander Gombert, Specialist in Vascular Surgery – RWTH Aachen University

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