Carbon Dioxide Insufflation and Brain Protection During Open Heart Surgery: A Randomised Controlled Trial - CO2 study

niversity Hospitals Bristol and Weston NHS Foundation Trust0 个研究点目标入组 704 人开始时间: 2020年7月3日最近更新: 2020年7月6日

适应症

试验速览

暂无简介。

•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

•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

发起方

niversity Hospitals Bristol and Weston NHS Foundation Trust