prospective randomized multicentre double-blind placebo-controlled trial of the use of aprotonin in...

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ity risk ranged from 2´7 per cent in younger patients with a low creatinine level and high FEV 1 to 7´8 per cent in older patients with above average creatinine levels and below average FEV 1 . There was no evidence of between-hospital or between- surgeon variability in postoperative risk. Conclusion: Poor preoperative lung and renal function were associated strongly with postoperative death. Age was less important once these two prognostic indicators were taken into account. The potential for preoperative improvement in lung and renal function to reduce the postoperative mortality rate should be addressed in future studies. Prospective randomized multicentre double-blind placebo-controlled trial of the use of aprotonin in ruptured abdominal aortic aneurysm repair J. Robinson, S. Nawaz, T. Whitbread and J. D. Beard, on behalf of the Joint Vascular Research Group Shef®eld Vascular Institute, Shef®eld, UK Background: This study assessed whether the use of aprotonin affects the number of blood products transfused, and the morbidity and mortality rates associated with the repair of a ruptured abdominal aortic aneurysm AAA). Methods: Nine centres with local ethics committee approval for the trial were involved in the recruitment of 77 patients. A bolus of either 2 million units of aprotonin, followed by an infusion of 500 000 units every 30 min, or placebo, was prepared and aprotonin was administered to 38 patients, with 39 receiving the placebo. The number of blood products transfused during surgery and in the ®rst 12 h after operation was noted, along with the incidence of complications, mortality rates and length of hospital stay. Analysis of the difference between blood product transfusion was by the Kruskal±Wallis test. Results: Seventeen of the 38 patients receiving aprotonin and 17 of the 39 given placebo died within 30 days, with an overall mortality rate of 44 per cent. The median amount of blood given to the aprotonin group after operation was 1 range 0± 14) units, while for the placebo group it was 3 range 0±13) units P = 0´02). In the aprotonin group, ten patients developed renal failure and ten had respiratory complications. The correspond- ing ®gures for the placebo group were nine and 17 respectively. For survivors, the median hospital stay was 12 range 7± 33) days for the aprotonin group and 15 range 8±52) days for the placebo group. Conclusion: The use of high-dose aprotonin in ruptured AAA repair leads to less requirement for blood products. It does not appear to affect survival or the incidence of postoperative complications. Outcome of 112 consecutive patients with an abdominal aortic aneurysm greater than 5´5 cm turned down for elective repair at a university hospital K. Conway, J. Byrne and I.F. Lane Vascular Surgical Unit, University Hospital of Wales, Cardiff, UK Background: The UK Small Aneurysm study has demonstrated the low risk of rupture in aneurysms less than 5´5 cm in diameter. However, the natural history of aneurysms greater than 5´5 cm remains unresolved. Questions of equipoise probably preclude another trial in patients with an AAA over 5´5 cm. In this centre, the authors prospectively maintain records of all patients refused elective aneurysm surgery. This study aimed to document the outcome of all patients referred with an AAA greater than 5´5 cm in diameter, and to determine the cause of death and risk of rupture in all patients. Methods: Details of all patients presenting with an AAA from 1989 to 1999 were recorded and demographic details on all patients with an AAA greater than 5´5 cm were collected. The endpoint was 1 May 1999. Copies of death certi®cates for deceased patients were obtained from the Of®ce of National Statistics, local in-hospital patient records and general practi- tioner records. Results of post-mortem examinations were also retrieved. Aneurysms were strati®ed according to size at presentation 5´5±5´9, 6´0±7´0, more than 7´0 cm) and reasons for non-intervention were documented. Results: Some 112 patients were turned down over 10 years 11´4 per year). The means.d.) age of this patient group was 77´77´7) years; there were 74 men and 38 women. Crude mortality data are shown in the Fig. below Kaplan±Meier 0 0·5 0·1 0·2 0·3 0·4 0·6 0·7 0·8 0·9 1·0 1 25 24 23 22 21 20 19 18 17 16 15 14 13 12 11 10 9 8 7 6 5 4 3 2 5·5–5·9 6·0–7·0 >7·0 Time (months) Cumulative survival 498 VSSGBI abstracts British Journal of Surgery 2000, 87, 490±516 www.bjs.co.uk ã 2000 Blackwell Science Ltd

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Page 1: Prospective randomized multicentre double-blind placebo-controlled trial of the use of aprotonin in ruptured abdominal aortic aneurysm repair

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