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Clinical Trials/ISRCTN87042095
ISRCTN87042095
Active, not recruiting
未知

Hypobaric oxygen during cardiopulmonary bypass to reduce gaseous micro-emboli during cardiac surgery: a randomized controlled trial

niversity Hospitals Bristol and Western NHS Foundation Trust0 sites40 target enrollmentJune 13, 2022

Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
niversity Hospitals Bristol and Western NHS Foundation Trust
Enrollment
40
Status
Active, not recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 13, 2022
End Date
April 1, 2024
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
niversity Hospitals Bristol and Western NHS Foundation Trust

Eligibility Criteria

Inclusion Criteria

  • 1\. Age \> \= 40 years
  • 2\. Having elective or urgent CABG or AVR (with or without an associated CABG procedure AVR±CABG) via a partial or full sternotomy using using central aortic perfusion cannulae CPB.

Exclusion Criteria

  • 1\. History of clinical stroke within 3 months prior to randomization
  • 2\. Cardiac catheterisation within 3 days of the planned surgery
  • 3\. Cerebral and/or aortic arch arteriography or interventions within 3 days of the planned surgery
  • 4\. Active endocarditis at time of randomisation
  • 5\. Planned concomitant aortic procedure such as root replacement
  • 6\. Clinical signs of cardiogenic shock or treatment with IV inotropic therapy prior to randomization
  • 7\. Myocardial infarction in the previous 4 days
  • 8\. Participation in an interventional (drug or device) trial
  • 9\. Unable to provide written informed consent
  • 10\. Prisoner

Outcomes

Primary Outcomes

Not specified

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