Oxygen monitoring/blood transfusion in patients having heart valve replacement surgery Surgery Complications following infusion, transfusion and therapeutic injection
Conditions
Interventions
The trial will compare two different algorithms for optimising tissue oxygenation during cardiopulmonary bypass (CPB), as follows:
1. "Generic algorithm" (including a standard transfusion threshold)
Sponsors
University Hospitals Bristol NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion 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
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 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 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 12/08/2015: Cognitive function: Recommended cognitive domains will be tested as follows: 1. Verbal memory: Rey Auditory Verbal Learning Test (AVLT) 2. Attention: First trial of the AVLT, Sustained and divided attention: Trail- Making Test parts A and B 3. Visuo-spatial: Block Design from the Wechsler Adult Intelligence Scale - Revised (WAIS-R) test 4. Motor coordination: Grooved Pegboard Test, dominant and non dominant hand 5. Executive function/Verbal fluency: Controlled Oral Word Association Test (COWAT) Primary outcome measures from 17/11/2010 to 12/08/2015: 1. Cognitive function: recommended cognitive domains will be tested as follows: 1.1. Verbal memory: Rey Auditory Verbal Learning Test (AVLT) 1.2. Attention: First trial of the AVLT, Sustained and divided attention: Trail- Making Test parts A and B 1.3. Visuo-spatial: Block Design from the Wechsler Adult Intelligence Scale - Revised (WAIS-R) test 1.4. Motor coordination: Grooved Pegboard Test, dominant and non dominant hand 1.5. Executive function/Verbal fluency: Controlled Oral Word Association Test (COWAT) 2. Infectious complications: a cumulative infection score will be calculated by supplementing data on wound infections (the ASEPSIS score that describes signs and symptoms of wound infection on a continuous scale) with data describing the severity of sepsis Primary outcome measures at time of registration: 1. Cognitive function: recommended cognitive domains will be tested as follows: 1.1. Verbal memory: Rey Auditory Verbal Learning Test (AVLT) 1.2. Attention: First trial of the AVLT, Sustained and divided attention: Trail- Making Test parts A and B 1.3. Psychomotor speed: Digit Symbol Test from the Weschler Adult Intelligence Scale - Revised (WAIS-R) test 1.4. Motor coordination: Grooved Pegboard Test, dominant and non dominant hand 1.5. Executive function/Verbal fluency: Controlled Oral Word Association Test (COWAT) 2. Infectious complications: | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 12/08/2015: 1. Units of RBC and other blood components transfused during the operative period and post-operative hospital stay 2. Cerebral oxygenation during the operative period 3. Oxygen delivery and utilisation during CPB 4. Euroqol EQ-5D at baseline and 6 weeks and 3 months after surgery 5. Length of intensive care unit (ICU)/high dependency unit (HDU) stay 6. Length of hospital stay 7. Clinical outcomes (defined as: stroke, ST elevation myocardial infarction, post-operative acute kidney injury, respiratory complications) during the post-operative hospital stay 8. Cumulative resource use, cost and cost-effectiveness 9. All-cause mortality within 30 days of surgery 10. Biochemical markers of organ injury during first 96 hours post-surgery 11. The occurrence of an infectious complication Secondary outcome measures from 17/11/2010 to 12/08/2015: 1. Units of RBC and other blood components transfused during the operative period and post-operative hospital stay 2. Cerebral oxygenation during the operative period 3. Oxygen delivery and utilisation during CPB 4. Euroqol EQ-5D at baseline and 6 weeks and 3 months after surgery 5. Length of intensive care unit (ICU)/high dependency unit (HDU) stay 6. Length of hospital stay 7. Clinical outcomes (defined as: stroke, ST elevation myocardial infarction, post-operative acute kidney injury, respiratory complications) during the post-operative hospital stay 8. Cumulative resource use, cost and cost-effectiveness 9. All-cause mortality within 30 days of surgery 10. Biochemical markers of organ injury during first 96 hours post-surgery Initial secondary outcome measures at time of registration: 1. Units of RBC and other blood components transfused during the operative period and post-operative hospital stay 2. Cerebral oxygenation during the operative period 3. Oxygen delivery and utilisation during CPB 4. Euroqol EQ-5D at baseline and 6 weeks and 3 months after surgery 5. Length | — |
Countries
United Kingdom
Outcome results
None listed