The CO2 study: Carbon Dioxide Insufflation and Brain Protection During Open Heart Surgery

Phase 1

• Conditions: Brain injury during open heart valve surgery; MedDRA version: 21.1Level: PTClassification code 10067967Term: Brain injurySystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 21.1Level: LLTClassification code 10048935Term: Open heart surgerySystem Organ Class: 100000004865; MedDRA version: 20.0Level: LLTClassification code 10077808Term: Mild neurocognitive disorderSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 20.0Level: PTClassification code 10001526Term: Air embolismSystem Organ Class: 10047065 - Vascular disorders; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

• Registration Number: EUCTR2020-001322-54-GB
• Lead Sponsor: niversity Hospitals Bristol and Weston NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-03
• Last Update Posted: 6 July 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 704

Inclusion Criteria

1. Age = 50 years
2. Planned left side aortic or mitral valve surgical repair or replacement (with or without another procedure, e.g. coronary artery bypass graft) via a partial or full sternotomy using central aortic perfusion cannulae
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 404

Exclusion Criteria

1. Contraindication to medical carbon dioxide: acquired or genetic of acidosis (i.e. renal tubular acidosis)
2. Contraindication to MRI (e.g. known intolerance, permanent pacemaker in situ or expected implantation of a permanent pacemaker)
3. History of clinical stroke within 3 months prior to randomisation
4. Cardiac catheterisation within 3 days of the planned surgery
5. Cerebral and/or aortic arch arteriography or interventions within 3 days of the planned surgery
6. Active endocarditis at time of randomisation
7. Planned concomitant aortic procedure such as root replacement
8. Clinical signs of cardiogenic shock or treatment with IV inotropic therapy prior to randomisation
9. Participation in an interventional (drug or device) trial
10. Unable to provide written informed consent
11. Prisoners

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified