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| [ ...Back to search results ] | [ Print-friendly version ] |
| A multi-centre randomised controlled trial of the effects of a reduction in the threshold for blood transfusion following heart surgery |
| ISRCTN | ISRCTN70923932 |
| ClinicalTrials.gov identifier | |
| Public title | A multi-centre randomised controlled trial of the effects of a reduction in the threshold for blood transfusion following heart surgery |
| Scientific title | A multi-centre randomised controlled trial of Transfusion Indication Threshold Reduction on transfusion rates, morbidity and healthcare resource use following cardiac surgery |
| Acronym | TITRe 2 |
| Serial number at source | HTA 06/402/94 |
| Study hypothesis |
Current information as of 01/09/09:
The hypothesis for the trial is that lowering the transfusion threshold for red cell transfusion from a haemoglobin (Hb) / haematocrit (Hct) level of 9 g/dL / 27 ("liberal", similar to current practice) to 7.5 g / dL / 22 ("restrictive") will reduce postoperative morbidity and NHS costs. Information at time of registration: The hypothesis for the trial is that lowering the transfusion threshold for red cell transfusion from a haemoglobin (Hb) level of 9 g/dL ("liberal", similar to current practice) to 7.5 g/dL ("restrictive") will reduce postoperative morbidity and NHS costs. More details can be found at: http://www.hta.ac.uk/1729 Protocol can be found at: http://www.hta.ac.uk/protocols/200604020094.pdf As of 01/09/09 this record has been extensively updated. All updates may be found under the relevant field with the above update date. Please also note that the contract address has been changed from "Bristol Royal Infirmary" to "Queen's Building". Please note that as of 24/08/10 this inclusion criteria and ethics approval information have been updated. All updates can be found in the relevant field with the above update date. |
| Lay summary | |
| Ethics approval |
Added 02/09/09:
1. First approved by Oxfordshire Regional Ethics Committee (REC) C on the 31st of October 2008 (ref: 08/H0606/125). Subsequent amendments were approved on 19 May 2009 and 14 July 2009. Added 24/08/10: 2. The latest ammendments included in this record were approved by the REC on the 30th of July 2010. Two further amendments were approved by the REC on the 9th of October 2009 and the 12th of April. These amendments do not affect the information shown on the ISRCTN page. |
| Study design | Multicentre randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Patients undergoing cardiac surgery |
| Participants - inclusion criteria |
Current information as of 24/08/10:
1. Adults of either sex, aged ≥16 2. Post-operative nadir Hb / Hct level below 9.0 g / dL / 27 Current information as of 01/09/09: 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 |
| Participants - exclusion criteria |
Current information as of 01/09/09:
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 |
| Anticipated start date | 01/12/2008 |
| Anticipated end date | 30/11/2011 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 2,000 |
| Interventions |
Current information as of 01/09/09:
The trial will compare two Hb thresholds for blood transfusion, "liberal" and "restrictive". The thresholds are defined as follows: A: Liberal (control, similar to current practice): participants randomised to this group will be eligible for transfusion if their post-operative nadir Hb / Hct level falls below 9.0 g / dL / 27. One unit of RBC should be transfused and the Hb level checked before transfusing another unit. The objective should be to maintain the Hb / Hct level above 9.0 g / dL / 27. B: Restrictive (experimental): participants randomised to this group will be eligible for transfusion if their post-operative nadir Hb / Hct level falls below 7.5 g / dL / 22. One unit of RBC should be transfused and the Hb level checked before transfusing another unit. The objective should be to maintain the Hb / Hct level above 7.5 g / dL / 22. Clinicians will be allowed to transfuse, or refuse to transfuse, in contravention of these thresholds but must document the reason(s). The total duration of follow-up for each participant is 3-months post randomisation, at which point participants will leave the study. However we are hoping to collect long-term mortality data from data held routinely by the NHS and will be seeking consent from participants for this. Initial information at time of registration: The trial will compare two Hb thresholds for blood transfusion, "liberal" and "restrictive". The thresholds are defined as follows: A: Liberal (control, similar to current practice): participants randomised to this group will be eligible for transfusion if their post-operative nadir Hb level falls below 9.0g/dL. One unit of RBC should be transfused and the Hb level checked before transfusing another unit. The objective should be to maintain the Hb level above 9.0g/dL. B: Restrictive (experimental): participants randomised to this group will be eligible for transfusion if their post-operative nadir Hb level falls below 7.5g/dL. One unit of RBC should be transfused and the Hb level checked before transfusing another unit. The objective should be to maintain the Hb level above 7.5g/dL. Clinicians will be allowed to transfuse, or refuse to transfuse, in contravention of these thresholds but must document the reason(s). The total duration of follow-up for each participant is 3-months post randomisation, at which point participants will leave the study. However we are hoping to collect long-term mortality data from data held routinely by the NHS and will be seeking consent from participants for this. |
| Primary outcome measure(s) |
Current information as of 01/09/09:
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 outcome measure(s) |
Current information as of 01/09/09:
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 EQ5D 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) |
| Sources of funding | NIHR Health Technology Assessment Programme - HTA (UK) |
| Trial website | |
| Publications | |
| Contact name | Prof Barney Reeves |
| Address |
Bristol Heart Institute
University of Bristol Level 7 Queen's Building Upper Maudlin Street |
| City/town | Bristol |
| Zip/Postcode | BS2 8HW |
| Country | United Kingdom |
| Sponsor | University Hospitals Bristol NHS Foundation Trust (UK) |
| Address |
Research and Development Department
Education Centre Level 3 Upper Maudlin Street |
| City/town | Bristol |
| Zip/Postcode | BS2 8AE |
| Country | United Kingdom |
| Sponsor website: | http://www.uhbristol.nhs.uk |
| Date applied | 01/09/2008 |
| Last edited | 24/08/2010 |
| Date ISRCTN assigned | 09/09/2008 |
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| © 2012 ISRCTN unless otherwise stated. | |
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