ISRCTN23557269Completed未知
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 enrollmentStarted: February 27, 2009Last updated:
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 200
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
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).
- •10. Patients with end stage renal failure or patients who have undergone renal transplantation.
- •11. Patients unable to complete the cognitive assessments required for the trial e.g. due to language difficulties, visual or hearing impairment.
- •12. Patients who were unable to give full informed consent for the study (e.g. language difficulties).
- •13. Patients already participating in another clinical (interventional) study.
- •Previous exclusion criteria (added 17/11/2010):
- •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 neuropsychological impairment as defined by previous psychiatric illness, stroke, intra-cerebral haemorrhage, preoperative Mini-Mental State Examination score >24 [37], and/or alcohol or drug addiction
- •6. 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 prednisole)
- •7. Patients with end stage renal failure or patients who have undergone renal transplantation
- •8. Patients unable to complete the cognitive assessments required for the trial e.g. due to language difficulties, visual or hearing impairment
- •9. Patients who were
Investigators
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