Postoperative ComplicationsTAAA-CytosorbNCT04765748
Cytokine Filter Usage During Open Thoracoabdominal Aortic Aneurysm Repair- a Single-center Randomized Prospective Trial
An observational study of Postoperative Complications and Inflammatory Response, run by RWTH Aachen University at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Postoperative Complications, Inflammatory Response
- What is being tested?
- Cytosorb
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 11 Feb 2021to 27 Dec 2022
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Adult, Older adult
Study population: All patients treated by open TAAA repair
Who may be able to join
- Suffering from a TAAA larger than 55mm
Who cannot join
- immunosupprive therapy pregnancy
- -
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Cytosorb
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CytosorbDevice
Cytokine filter, which can be used intraoperatively while using a heart lung machine
| Study group | Role | What they receive |
|---|---|---|
| TAAA patients with Cytosorb | Patients suffering from a TAAA larger than 55mm Receives: Device: Cytosorb | |
| TAAA patients without Cytosorb | Patients suffering from a TAAA larger than 55mm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of perioperative catecholamine usage in mg/dl for the first seven days after surgery
amount measured in mg/dl
Measured: 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
Measured: 7 days perioperatively 5-10 day postoperatively
Secondary outcomes (2)
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
Measured: 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
Measured: 12 months 10-14 months postopertaibely
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start11 Feb 2021
- Primary completion27 Nov 2022
- Study completion27 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Gombert, RWTH Aachen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04765748
- Sponsor's protocol ID
- 20-031
- Acronym
- TAAA-Cytosorb
- Status last verified
- Apr 2024
- First submitted
- 17 Feb 2021
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04765748
- Acronym / sponsor ID
- TAAA-Cytosorb / 20-031
- Conditions
- Postoperative Complications, Inflammatory Response
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- 11 Feb 2021 (actual)
- Primary completion
- 27 Nov 2022 (actual)
- Study completion
- 27 Dec 2022 (actual)
- First posted
- 21 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAAA patients with Cytosorb | – | Device: CytosorbPatients suffering from a TAAA larger than 55mm |
| TAAA patients without Cytosorb | – | –Patients suffering from a TAAA larger than 55mm |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients treated by open TAAA repair
Key inclusion criteria (1 listed)
- Suffering from a TAAA larger than 55mm
Key exclusion criteria (2 listed)
- immunosupprive therapy pregnancy
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CytosorbCytokine filter, which can be used intraoperatively while using a heart lung machine | Device | TAAA patients with Cytosorb |
Primary outcome
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
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
2 secondary outcomes
Acute kidney injury, measured using serum creatinine in mg/dl
Time frame: 7 days perioperatively, -10 day postoperatively
Patients survival for the first 12 months after surgery
Time frame: 12 months 10-14 months postopertaibely
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Complications and Inflammatory Response, run by RWTH Aachen University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of perioperative catecholamine usage in mg/dl for the first seven days after surgery (time frame: 7 days perioperatively -10 day postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2024.