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| [ ...Back to search results ] | [ Print-friendly version ] |
| A randomised controlled trial of patient-specific oxygen monitoring to reduce blood transfusion during heart surgery |
| ISRCTN | ISRCTN23557269 |
| ClinicalTrials.gov identifier | |
| Public title | A randomised controlled trial of patient-specific oxygen monitoring to reduce blood transfusion during heart surgery |
| Scientific title | Patient-specific cerebral oxygentation monitoring as part of an algorithm to reduce transfusion during heart valve surgery: a randomised controlled trial |
| Acronym | PASPORT |
| Serial number at source | CS/2008/3057 |
| Study hypothesis |
The hypothesis for the trial is that a patient-specific, goal-directed algorithm (based on optimising regional cerebral oxygen saturation), combined with a pre-specified "restrictive" haematocrit transfusion threshold of 18, will result in fewer red blood cell (RBC) transfusions and will reduce complications arising from unnecessary transfusion and from low oxygen levels during cardiopulmonary bypass, when compared with the currently used "generic" algorithm for monitoring and optimising oxygen levels.
Please note that as of 17/11/10 this record has been extensively updated to reflect the amendment to the protocol approved by the Research Ethics Committee on 09/11/09. Two further amendments do not affect the information shown on this record. Please also note that the start and end dates of this trial have been extended from 10/04/09 and 30/09/10 to 01/12/09 and 31/12/12 respectively Please note, as of 09/08/2011 updates were made to this trial after further protocol amendments. The study has changed from a single-centre to multi-centre trial following the addition of Castle Hill Hospital. |
| Lay summary | Not provided at time of registration |
| Ethics approval | The local Research Ethics Committee (REC) approved on 15/06/2009. Amendments to the protocol were approved on 09/11/2009, 19/01/2010,12/02/2010, 17/05/2011 and 27/07/2011. |
| Study design | Randomised controlled single centre trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Oxygen monitoring/ blood transfusion in patients having heart valve replacement surgery |
| Participants - inclusion criteria |
Current information as of 17/11/10:
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 |
| Participants - 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 excluision criteria (added 17/11/10): 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 unable to give full informed consent for the study (e.g. language difficulties) 10. Patients already participating in another clinical (interventional) study Initial exclusion criteria 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 who may have higher perioperative haemoglobin requirements (e.g., emergency cases, preoperative ejection fraction <30%, cerebrovascular occlusive disease [arterial stenosis >75%] or critical limb ischaemia) 3. Patients with congenital or acquired RBC, platelet or clotting factor disorders (excluding those receiving antiplatelet therapy, warfarin or other systemic oral anticoagulants) 4. Patients with neuropsychological impairment as defined by previous psychiatric illness, stroke, transient ischaemic attacks, intra-cerebral haemorrhage, preoperative Mini-Mental State Examination score <24, and/or alcohol or drug addiction 5. Patients with a pre-existing inflammatory state (e.g., sepsis, active inflammatory disease) 6. Patients at risk of impaired cerebral autoregulation (e.g., diabetics requiring insulin, patients aged >80 years, untreated malignant hypertension) 7. Patients who were unable to give full informed consent for the study (e.g., learning or language difficulties) 8. Patients already participating in another clinical (interventional) study |
| Anticipated start date | 01/12/2009 |
| Anticipated end date | 31/12/2012 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 150 |
| 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): A generic algorithm for optimising tissue oxygenation based on global measures of oxygen utilisation and including a pre-defined intraoperative haematocrit transfusion threshold of 23 (current "standard practice", i.e. our existing protocol). 2. "Patient-specific algorithm" (including a restrictive transfusion threshold): A patient-specific, goal-directed, algorithm based on monitoring and optimisation of regional cerebral oxygen saturation, combined with a predefined "restrictive" intraoperative haematocrit transfusion threshold of 18 (experimental arm). |
| Primary outcome measure(s) |
The co-primary outcome measures are cognitive function and infectious complications during the first three months post-surgery.
Current information as of 17/11/10 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 Initial information 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: 2.1. Septicaemia 2.2. Lower respiratory tract infection 2.3. Urinary sepsis 2.4. Wound infection |
| Secondary outcome measure(s) |
Amendments as of 17/11/10:
7. Clinical outcomes (defined as: stroke, ST elevation myocardial infarction, post-operative acute kidney injury, respiratory complications) during the post-operative hospital stay 10. Biochemical markers of organ injury during first 96 hours post-surgery Initial information 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 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 renal dysfunction, 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 48 hours post-surgery |
| Sources of funding | NIHR Programme Grant for Applied Research (UK) (ref: RP-PG-0407-10384) |
| Trial website | |
| Publications | |
| Contact name | Prof Barney Reeves |
| Address |
Bristol Heart Institute
University of Bristol Level 7 Bristol Royal Infirmary Upper Maudlin Street |
| City/town | Bristol |
| Zip/Postcode | BS2 8HW |
| Country | United Kingdom |
| Sponsor | University Hospitals Bristol NHS Foundation Trust (UK) |
| Address |
Research and Effectiveness 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 | 13/01/2009 |
| Last edited | 09/08/2011 |
| Date ISRCTN assigned | 27/02/2009 |
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| © 2012 ISRCTN unless otherwise stated. | |
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