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NCT Number: NCT04765748

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

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.

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Key information

Conditions

Postoperative Complications Inflammatory Response Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Alexander Gombert

Aachen, North Rhine-Westphalia, 52074, Germany

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Suffering from a TAAA larger than 55mm

Exclusion criteria

immunosupprive therapy pregnancy

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Treatment and study plan

CytoSorb

Device

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

Primary outcomes

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

    Time frame: 7 days perioperatively -10 day postoperatively

    amount measured in mg/dl

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

    Time frame: 7 days perioperatively 5-10 day postoperatively

    packed cells, erythrocyte concentrate

Secondary outcomes

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

    Time frame: 7 days perioperatively, -10 day postoperatively

    AKI assessed according to the KDIGO classification perioperatively for the first 7 days after surgery

  2. Patients survival for the first 12 months after surgery

    Time frame: 12 months 10-14 months postopertaibely

    Survival yes/no within the first 12 months after surgery

Sponsors and collaborators

Lead sponsor

RWTH Aachen University

Other

Registry information

Official study title

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

Acronym: TAAA-Cytosorb

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 21, 2021
Registry last updated
Apr 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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