A randomised controlled trial of patient-specific oxygen monitoring to reduce blood transfusion during heart surgery
- Conditions
- Oxygen monitoring/blood transfusion in patients having heart valve replacement surgerySurgeryComplications following infusion, transfusion and therapeutic injection
- Registration Number
- ISRCTN23557269
- Lead Sponsor
- niversity Hospitals Bristol NHS Foundation Trust (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 200
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method