Patient-specific cerebral oxygentation monitoring as part of an algorithm to reduce transfusion during heart valve surgery: a randomised controlled trial

niversity Hospitals Bristol NHS Foundation Trust (UK)0 sites200 target enrollmentFebruary 27, 2009

Overview

Phase: 未知
Intervention: Not specified
Conditions: Not specified
Sponsor: niversity Hospitals Bristol NHS Foundation Trust (UK)
Enrollment: 200
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

February 27, 2009

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

niversity Hospitals Bristol NHS Foundation Trust (UK)

Eligibility Criteria

Inclusion Criteria

•Current information as of 17/11/2010:
•1\. Adults \= 16 years of either sex undergoing valve or combined coronary artery bypass graft (CABG) and valve surgery at the Bristol Royal Infirmary
•2\. Patients giving informed consent to participate and who are suitable for allocation to either transfusion protocol
•Initial information at time of registration:
•1\. Adults (\>\= 16 years and \<80 years) of either sex undergoing valve or combined coronary artery bypass graft (CABG) and valve surgery at the Bristol Royal Infirmary
•2\. Patients giving informed consent to participate and who are suitable for allocation to either transfusion protocol

Exclusion Criteria

•Current exclusion criteria as of 09/08/2011:
•1\. Patients undergoing emergency cardiac surgery (emergency surgery defined as surgery taking place before the end of the same working day as admission).
•2\. Patients who are prevented from having blood and blood products according to a system of beliefs (e.g. Jehovah's Witnesses).
•3\. Patients who may have higher perioperative haemoglobin requirements (e.g. preoperative ejection fraction \< 30%, cerebrovascular occlusive disease \[arterial stenosis \> 75%] or critical limb ischemia).
•4\. Patients with congenital or acquired RBC, platelet or clotting factor disorders, (excluding those receiving antiplatelet therapy, warfarin or other systemic oral anticoagulants).
•5\. Patients with a neurological disorder (e.g. epilepsy, Alzheimer's, dementia and Parkinson's disease)
•6\. Patients with a diagnosed psychiatric disorder (e.g. schizophrenia, psychosis), drug or alcohol addiction.
•7\. Patients with an already identified cognitive impairment (e.g. memory and/or attentional deficits) as defined by psychometric assessment or a preoperative Mini\-Mental State Examination score \< 24 \[37].
•8\. Patients who have previously sustained a stroke, intra\-cerebral haemorrhage, acquired brain injury.
•9\. Patients with a pre\-existing inflammatory state (e.g. sepsis, active inflammatory disease including active rheumatoid arthritis, colitis, Lupus, or Crohn's disease. NB consider latter conditions as active conditions when a patient is taking a high dose of oral steroids, for example \> 10 mg/day of prednisolone/prednisone).