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"Collett, Dave"
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Protocol of a randomised controlled, open-label trial of ex vivo normothermic perfusion versus static cold storage in donation after circulatory death renal transplantation
2017
IntroductionEx vivo normothermic perfusion (EVNP) is a novel technique that reconditions the kidney and restores renal function prior to transplantation. Phase I data from a series of EVNP in extended criteria donor kidneys have established the safety and feasibility of the technique in clinical practice.Methods and analysisThis is a UK-based phase II multicentre randomised controlled trial to assess the efficacy of EVNP compared with the conventional static cold storage technique in donation after circulatory death (DCD) kidney transplantation. 400 patients receiving a kidney from a DCD donor (categories III and IV, controlled) will be recruited into the study. On arrival at the transplant centre, kidneys will be randomised to receive either EVNP (n=200) or remain in static cold storage (n=200). Kidneys undergoing EVNP will be perfused with an oxygenated packed red cell solution at near body temperature for 60 min prior to transplantation. The primary outcome measure will be determined by rates of delayed graft function (DGF) defined as the need for dialysis in the first week post-transplant. Secondary outcome measures include incidences of primary non-function, the duration of DGF, functional DGF defined as <10% fall in serum creatinine for 3 consecutive days in the first week post-transplant, creatinine reduction ratio days 2 and 5, length of hospital stay, rates of biopsy-proven acute rejection, serum creatinine and estimated glomerular filtration rate at 1, 3, 6 and 12 months post-transplant and patient and allograft survival. The EVNP assessment score will be recorded and the level of fibrosis and inflammation will also be measured using tissue, blood and urine samples. Ethics and dissemination. The study has been approved by the National Health Service (NHS) Health Research Authority Research Ethics Committee. The results are expected to be published in 2020.Trial registration numberISRCTN15821205; Pre-results.
Journal Article
Potential for organ donation in the United Kingdom: audit of intensive care records
by
Barber, Kerri
,
Hamilton, Claire
,
Collett, Dave
in
Attitude to Health
,
Audit objectives
,
Brain stem
2006
Objectives To determine the true potential for solid organ donation from deceased heartbeating donors and the reasons for non-donation from potential donors. Design An audit of all deaths in intensive care units, 1 April 2003 to 31 March 2005. The study was hierarchic, in that information was sought on whether or not brain stem testing was carried out; if so, whether or not organ donation was considered; if so whether or not the next of kin were approached; if so, whether or not consent was given; if so, whether or not organ donation took place. Setting 341 intensive care units in 284 hospitals in the United Kingdom. Participants 46 801 dead patients, leading to 2740 potential heartbeating solid organ donors and 1244 actual donors. Main outcome measures Proportion of potential deceased heartbeating donors considered for organ donation, proportion of families who denied consent, and proportion of potential donors who became organ donors. Results Over the two years of the study, 41% of the families of potential donors denied consent. The refusal rate for families of potential donors from ethnic minorities was twice that for white potential donors, but the age and sex of the potential donor did not affect the refusal rate. In 15% of families of potential donors there was no record of the next of kin being approached for permission for organ donation. Conclusions Intensive care units are extremely good in considering possible organ donation from suitable patients. The biggest obstacle to improving the organ donation rate is the high proportion of relatives who deny consent.
Journal Article
Intracranial haemorrhage in thrombocytopenic haematology patients—a nested case–control study: the InCiTe study protocol
2014
Introduction Intracranial haemorrhage (ICH) is one of the most serious side-effects of severe thrombocytopenia in haematology patients. ICH is rare, but can have devastating consequences (death or major morbidity). It is unknown why some patients with severe thrombocytopenia bleed and others do not. Study aims Primary aim was to identify risk factors for ICH in patients with haematological malignancies. Secondary aims were to identify short-term outcomes for these patients at 30 days (major morbidity and mortality) and produce a more accurate estimate of ICH incidence in this population. This information is key to identifying means to improve treatment and quality of care. Methods/analysis This is a UK-wide case–control study of ICH nested within a 4-year prospective surveillance study set up specifically for the case–control study. Each case will be matched to one control. Cases will be adult haematology patients (≥16 years) who have had any type or severity of ICH who are receiving, about to receive or have just received myeloablative chemotherapy (defined as chemotherapy expected to cause a significant thrombocytopenia <50×109/L for >5 days) or a haemopoietic stem cell transplant. Only patients being treated with curative intent will be included. Controls will be patients who fulfil the same inclusion criteria as cases (apart from ICH) and were treated at the same hospital immediately before the index case. Cases and controls will be matched to type of treatment (myeloablative chemotherapy or haemopoietic stem cell transplant). Hospitals across the UK will participate in a monthly email reporting strategy (started June 2011), as to whether a case of ICH occurred during the preceding calendar month. Case and control forms will be sent to any hospital reporting an eligible case. Conditional logistic regression will be used to calculate ORs. Denominator data for incidence estimates will use national registry data. Study Registration ISRCTN05026912 (prospective registration). NIHR Portfolio (UKCRN ID 10712).
Journal Article
Effect of “collaborative requesting” on consent rate for organ donation: randomised controlled trial (ACRE trial)
2009
Objective To determine whether collaborative requesting increases consent for organ donation from the relatives of patients declared dead by criteria for brain stem death.Design Unblinded multicentre randomised controlled trial using a sequential design. Centralised 24 hour telephone randomisation based on randomised permuted blocks of 10.Setting 79 general, neuroscience, and paediatric intensive care units in the United Kingdom.Participants 201 relatives of patients meeting criteria for brain stem death. Relatives were blind to the intervention and to the trial; all other participants were necessarily unblinded.Interventions Collaborative requesting for consent for organ donation by the potential donor’s clinician and a donor transplant coordinator (organ procurement officer) compared with routine requesting by the clinical team alone.Main outcome measure Proportion of relatives consenting to organ donation.Results 101 relatives were randomised to routine requesting and 100 to collaborative requesting. All were analysed on an intention to treat basis. In the routine requesting group, 62 relatives consented to organ donation. In the collaborative requesting group, 57 relatives consented. After correction for the ethnicity, age, and sex of the potential donors the risk adjusted ratio of the odds of consent in the collaborative requesting group relative to the routine group was 0.80 (95% confidence interval 0.43 to 1.53), with a P value of 0.49 adjusted for interim analysis and trial over-running. The conversion rate (donors with consent from whom any organs were retrieved) was 92% (57/62) in the routine requesting group and 79% (45/57) in the collaborative requesting group (P=0.043). There were 140 approaches to relatives in the per protocol analysis, leading to 60.3% (44/73) consent after routine and 67.2% (45/67) after collaborative requesting (risk adjusted odds ratio of consent 1.47, 0.67 to 3.20, P=0.33).Conclusion There is no increase in consent rates for organ donation when collaborative requesting is used in place of routine requesting by the patient’s clinician.Trial registration ISRCTN01169903
Journal Article
4. Alcohol and Illness: The Epidemiological Viewpoint
1993
4. Alcohol and Illness: the Epidemiological Viewpoint. Edited by J. C. Duffy. ISBN 0 7486 0353 0. Edinburgh University Press, Edinburgh, 1992. 154 pp. £25.00.
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