Patients undergoing cardiac surgery Surgery
Conditions
Interventions
Current information as of 01/09/2009:
The trial will compare two Hb thresholds for blood transfusion, 'liberal' and 'restrictive'. The thresholds are defined as follows:
A: Liberal (control, simila
Sponsors
University Hospitals Bristol NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 24/08/2010: 1. Adults of either sex, aged =16 2. Post-operative nadir Hb / Hct level below 9.0 g / dL / 27 Previous inclusion criteria from 01/09/2009 to 24/08/2010: 1. Adults of either sex, aged =16 and <80 years 2. Post-operative nadir Hb / Hct level below 9.0 g / dL / 27 Initial information at time of registration: 1. Adults of either sex, aged =16 and <80 years 2. Post-operative nadir Hb level below 9.0 g/dL
Exclusion criteria
Exclusion criteria: Current information as of 01/09/2009: 1. Patients who are prevented from having blood and blood products according to a system of beliefs (e.g., Jehovah's Witnesses) 2. Patients with congenital or acquired platelet, red cell or clotting disorders 3. Patients with ongoing or recurrent sepsis 4. Patients who were unable to give full informed consent for the study (e.g., learning or language difficulties) 5. Patients with critical limb ischaemia 6. Patients undergoing emergency surgery 7. Patients already participating in another interventional research study Initial information at time of registration: 1. Patients who are prevented from having blood and blood products according to a system of beliefs (e.g., Jehovah's Witnesses) 2. Patients with congenital or acquired platelet, red cell or clotting disorders 3. Patients with ongoing or recurrent systemic sepsis 4. Patients who were unable to give full informed consent for the study (e.g., learning or language difficulties) 5. Patients with a critical carotid artery stenosis (>75%) or critical limb ischaemia 6. Patients with flow limiting (>70% luminal stenosis) coronary artery disease not undergoing complete revascularisation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current information as of 01/09/2009: A composite of serious infectious or ischaemic events in the first 3 months after randomisation. The infectious and ischaemic events to be recorded will include the following: 1. Infectious events: 1.1. Sepsis 1.2. Wound infection 2. Ischaemic events: 2.1. Permanent stroke 2.2. Myocardial infarction 2.3. Acute kidney injury 2.4. Gut infarction Initial information at time of registration: A composite of serious infectious or ischaemic events in the first 3 months after randomisation. The infectious and ischaemic events to be recorded will include the following: 1. Infectious events: 1.1. Septicaemia 1.2. Lower respiratory tract infection 1.3. Urinary sepsis 1.4 Wound infection 2. Ischaemic events: 2.1. Permanent stroke 2.2. Myocardial infarction 2.3. Renal failure 2.4. Gut infarction | — |
Secondary
| Measure | Time frame |
|---|---|
| Current information as of 01/09/2009: 1. Units of red blood cells transfused, recorded for the duration of hospital stay post-randomisation 2. Proportion of patients experiencing an infectious event 3. Proportion of patients experiencing an ischaemic event 4. EuroQol EQ-5D 5. Duration of ICU/HDU stay post-operatively 6. Duration of post-operative hospital stay 7. All cause mortality, recorded for duration of participation in study (3 months post-randomisation) 8. Cumulative resource use, cost, and cost-effectiveness, assessed for duration of participation in study (3 months post-randomisation) Initial information at time of registration: 1. Units of red blood cells transfused, recorded for the duration of hospital stay post-randomisation 2. Frequency of infectious events, recorded for the duration of hospital stay post-randomisation 3. Frequency of ischaemic events, recorded for the duration of hospital stay post-randomisation 4. EuroQol EQ-5D, assessed at baseline (pre-randomisation) and 3-months follow-up 5. Length of ICU stay, recorded for the duration of hospital stay post-randomisation 6. Length of hospital stay 7. All cause mortality, recorded for duration of participation in study (3 months post-randomisation) 8. Cumulative resource use, cost, and cost-effectiveness, assessed for duration of participation in study (3 months post-randomisation) | — |
Countries
United Kingdom
Outcome results
None listed