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Trial record 20 of 2064 for:    CARBON DIOXIDE AND dioxide

CARbon Dioxide Flooding for Reduction of Neurological Injury Following Surgery for Acute Type A Aortic Dissection (CARTA)

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ClinicalTrials.gov Identifier: NCT04962646
Recruitment Status : Not yet recruiting
First Posted : July 15, 2021
Last Update Posted : July 16, 2021
Sponsor:
Information provided by (Responsible Party):
Region Skane

Brief Summary:

Aortic dissection is a life-threatening condition and a consequence of a tear of the innermost of the three aortic layers- the intima. When a tear occurs, blood surges through the tear and causes the flow of blood between the aortic layers, causing a "false lumen". This causes a weakening of the aortic wall and hinders the blood from reaching its target organs and life saving emergent surgery is performed as routine.

Approximately 20% of patients undergoing acute type a aortic dissection (ATAAD) surgery suffer from postoperative neurological injuries and It has been demonstrated that neurological injuries account for 10-15% of in-hospital deaths.

In association with other cardiac procedures where the left side of the heart is opened and air may be trapped within the arterial circulation, carbon dioxide flooding is used to displace open air from the surgical wound. In comparison to air, carbon dioxide is significantly more soluble in blood and may therefore decrease the risk of air embolism. In cardiac surgery, carbon dioxide flooding has been demonstrated to reduce levels of biomarkers of cerebral injury, but carbon dioxide is not routinely employed in ATAAD surgery and has not been studied in association with these procedures.

The hypothesis is that carbon dioxide flooding reduces cerebral air embolism and the aim of thos project is to evaluate whether carbon dioxide flooding may reduce neurological injuries following ATAAD surgery.

This is a prospective, randomized, controlled, patient- and reviewer blinded interventional study. Patients will be randomised to undergo surgery with carbon-dioxide flooding at 5L/min to the open chest cavity or conventional surgery without carbon dioxide flooding. Remaining aspects of the procedure will be identical.

The patient, external statistician and the reviewer analyzing the primary endpoints will be blinded for the randomization arms.

The study will assess the following endpoints:

Primary outcomes: Presence, number and volume of ischaemic lesions observed using magnetic resonance imaging (MRI) after ATAAD surgery.

Secondary outcomes: Clinical signs of neurological injury. Levels of biomarkers of neurological injury (S100B, neuron specific enolase (NSE) , neurofilament protein (NFL), Glial fibrillary acid protein (GFAP) , Ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1) and Tau-protein (TAU)) before and after surgery. Quality of life, postoperative recovery and neurological function after ATAAD surgery. Primary outcomes in relation to retrograde cerebral perfusion.

Start of inclusion is anticipated to start Sep 1st, 202. The writing of a manuscript describing the study methods and study objectives is expected to be started in 2021 and the final manuscript is expected to be written during 2025.

An interim analysis of the primary endpoints and the safety arm will be performed after 20 patients have been included in each arm. An external statistician together with the principle investigator will hereafter decide for the study to be continued or terminated due to harms, futility or superiority.

The safety arm will include intraoperative mortality, in-hospital mortality, re-operation for bleeding, stroke, myocardial infarction or other thromboembolic events.


Condition or disease Intervention/treatment Phase
D000784 D020521 Procedure: Carbon dioxide flooding Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, randomized, controlled, patient- and reviewer blinded interventional study.
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: CARbon Dioxide Flooding for Reduction of Neurological Injury Following Surgery for Acute Type A Aortic Dissection - A Prospective, Randomized, Blinded, Controlled Clinical Trial
Estimated Study Start Date : September 1, 2021
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Floods

Arm Intervention/treatment
Experimental: Intervention
Once the thoracic cavity os opened during surgery, carbon dioxide flooding using a diffusor will be instigated with a flow of 5L/min. The flooding will be terminated once the aorta and the heart have no open contact with surrounding air.
Procedure: Carbon dioxide flooding
Once the thoracic cavity is opened a flow of carbon dioxide of 5L/min will be initiated into the surgical wound and proceed until there is no connection between the cardiac or aortic cavity and surrounding air.

No Intervention: Control
No intervention. No sham will be used as the staff performing the surgery would have been able to detect the lack of carbon dioxide in the surgical wound.



Primary Outcome Measures :
  1. Number of ischemic lesions on magnetic resonance imaging (MRI) [ Time Frame: MRI will be performed before postoperative day 7. When not possible due to medical considerations, MRI may be performed up to 30 days after surgery. ]
    Number of ischemic lesions visualized using MRI

  2. Size of ischemic lesions on magnetic resonance imaging (MRI) [ Time Frame: MRI will be performed before postoperative day 7. When not possible due to medical considerations, MRI may be performed up to 30 days after surgery. ]
    Size of ischemic lesions visualized using MRI


Secondary Outcome Measures :
  1. Clinical neurological injury [ Time Frame: Up to postoperative day 7. ]
    Clinical focal neurological injuries or coma verified by ischemic lesions on MRI or by clinical assessment by neurologist or NIHSS if the patient does not survive until MRI is performed.

  2. Neurological function [ Time Frame: Up to postoperative day 7. ]
    Patients will be assessed using the NIH Stroke Scale (NIHSS). Minimum score 0 points, maximum score 42 points, with 42 points being the worst outcome.

  3. Level of consciousness [ Time Frame: Up to postoperative day 7. ]
    Patients will be assessed using the Glasgow coma scale. Minimum score 3 points, maximum score 15 points, with 15 points being the best outcome.

  4. Levels of S100B. [ Time Frame: Preoperatively, at postoperative arrival to the intensive care unit, postoperative day 4 and 3 months after surgery. ]
    Concentration of S100B at predefined time points.

  5. Levels of NSE. [ Time Frame: Preoperatively, at postoperative arrival to the intensive care unit, postoperative day 4 and 3 months after surgery. ]
    Concentration of NSE at predefined time points.

  6. Levels of NFL. [ Time Frame: Preoperatively, at postoperative arrival to the intensive care unit, postoperative day 4 and 3 months after surgery. ]
    Concentration of NFL at predefined time points.

  7. Levels of GFAP. [ Time Frame: Preoperatively, at postoperative arrival to the intensive care unit, postoperative day 4 and 3 months after surgery. ]
    Concentration of GFAP at predefined time points.

  8. Levels of UCH-L1. [ Time Frame: Preoperatively, at postoperative arrival to the intensive care unit, postoperative day 4 and 3 months after surgery. ]
    Concentration of UCH-L1 at predefined time points.

  9. Levels of TAU. [ Time Frame: Preoperatively, at postoperative arrival to the intensive care unit, postoperative day 4 and 3 months after surgery. ]
    Concentration of TAU at predefined time points.

  10. Neurological motor-function after ATAAD surgery. [ Time Frame: 3 months after surgery. ]
    Patients will be assessed using the NIH Stroke Scale (NIHSS) three months after surgery. Minimum score 0 points, maximum score 42 points, with 42 points being the worst outcome.

  11. Cognitive function after ATAAD surgery. [ Time Frame: 3 months after surgery. ]
    Patients will be assessed using the Montereal cognitive assesment (MoCA) test. Minimum score 0 points, maximum score 30 points, with 30 points being the best outcome.

  12. Neurocognitive function after ATAAD surgery. [ Time Frame: 3 months after surgery. ]
    Patients will be assessed using the Symbol digit modalities test (SDMT). Minimum score 0 points, maximum score 110 points, with 110 points being the best outcome.

  13. Postoperative recovery after ATAAD surgery. [ Time Frame: 3 months after surgery. ]
    Patients will be assessed using the Postoperative recovery profile. Minimum score 19 points, maximum score 76 points, with 76 points being the best outcome.

  14. Quality of life after ATAAD surgery. [ Time Frame: 3 months after surgery. ]
    Patients will be assessed using the Satisfaction with life scale. Minimum score 0 points, maximum score 35 points, with 35 points being the best outcome.

  15. Size of ischemic lesions on magnetic resonance imaging (MRI) in relation to the use of retrograde cerebral perfusion. [ Time Frame: MRI will be performed before postoperative day 7. When not possible due to medical considerations, MRI may be performed up to 30 days after surgery. ]
    Size of ischemic lesions visualized using MRI analysed in subgroups with patients that have received retrograde cerebral perfusion and those who have not.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Verified acute type A aortic dissection.
  • Patient accepted for surgical repair.

Exclusion Criteria:

  • Preoperative neurological symptoms defined as focal neurological symptoms or altered state of consciousness at time of inclusion.
  • Previous cardiac surgery.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04962646


Contacts
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Contact: Igor Zindovic, MD, PhD +4646175288 igor.zindovic@med.lu.se

Sponsors and Collaborators
Region Skane
Investigators
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Principal Investigator: Igor Zindovic, MD. PhD Region Skåne, Skåne university hospital
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Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT04962646    
Other Study ID Numbers: 2021-02039
First Posted: July 15, 2021    Key Record Dates
Last Update Posted: July 16, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Region Skane:
Aorta, Dissection, Stroke
Additional relevant MeSH terms:
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Trauma, Nervous System
Aneurysm, Dissecting
Aneurysm
Vascular Diseases
Cardiovascular Diseases
Nervous System Diseases
Wounds and Injuries