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

Cytokine Filter Usage During Open Thoracoabdominal Aortic Aneurysm Repair- a Single-center Randomized Prospective Trial- Cytosorb and Its Imapct on Open TAAA Repair Outcome

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Complications; Inflammatory Response
• Intervention / Treatment: Device: Cytosorb

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.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Aachen, NRW, Germany, 52074
      • Alexander Gombert

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

All patients treated by open TAAA repair

Description

Inclusion Criteria:

Suffering from a TAAA larger than 55mm

Exclusion Criteria:

immunosupprive therapy pregnancy

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Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
TAAA patients with Cytosorb; Patients suffering from a TAAA larger than 55mm	Device: Cytosorb; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute kidney injury, measured using serum creatinine in mg/dl	AKI assessed according to the KDIGO classification perioperatively for the first 7 days after surgery	7 days perioperatively, -10 day postoperatively
Patients survival for the first 12 months after surgery	Survival yes/no within the first 12 months after surgery	12 months 10-14 months postopertaibely

Collaborators and Investigators

• Sponsor: RWTH Aachen University

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2021
• Primary Completion (Actual): November 27, 2022
• Study Completion (Actual): December 27, 2022

Study Registration Dates

• First Submitted: February 17, 2021
• First Submitted That Met QC Criteria: February 19, 2021
• First Posted (Actual): February 21, 2021

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aortic Aneurysm, Abdominal; Postoperative Complications; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Thoracoabdominal
• Other Study ID Numbers: 20-031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No