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

Postoperative Complications Clinical Trial

— TAAA-Cytosorb  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04765748
• Other study ID #: 20-031
• Status: Completed
• Start date: February 11, 2021
• Est. completion date: December 27, 2022

Study information

• Verified date: April 2024
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 27, 2022
• Est. primary completion date: November 27, 2022
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

Suffering from a TAAA larger than 55mm Exclusion Criteria: immunosupprive therapy pregnancy -

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Thoracoabdominal
• Inflammatory Response
• Postoperative Complications

Intervention

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

Locations

Country	Name	City	State
Germany	Alexander Gombert	Aachen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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