© 2004 European Academy of Anaesthesiology, European Journal of Anaesthesiology 21 (Suppl. 33): 2–36 Coagulation 9 009 A pilot double blind randomized placebo controlled trial of the use of recombinant factor VIIa (rfVIIa) in high transfusion risk cardiac surgery P. Diprose, M. Herbertson, D. O’Shaughnessy, R. Gill Departments of Anaesthesia and Haematology, Southampton University Hospitals NHS Trust, Southampton, Hampshire, UK Introduction: Peri-operative bleeding can be severe in patients undergoing complex cardiac surgery. The causes for this are multi-factorial. As would be expected, initial open label reports of the use of rFVIIa after cardiac surgery were encouraging [1,2]. We report the first double blind randomized use of this novel haemostatic agent in the setting of cardiac surgery. Method: After instituitional approval and informed consent, 20 patients were randomized to receive either placebo or 90 mcg/kg of rFVIIa after pro- tamine following the end of CPB. Patients were included if they were sched- uled to have surgery with a high risk of transfusion (including double valve replacements, acute endocarditis and aortic root replacements). Primary end points were the proportion of patients exposed to blood or blood prod- ucts, the total number of allogeneic units transfused per patient, and, the quantity of shed mediastinal blood. Fisher’s exact test was used to compare proportions exposed to products, and, the Mann-Whitney U test for com- paring number of allogeneic units exposed to each patient and mediastinal drainage. Results: A total of 19 patients completed the study and were analysed (one patient was excluded due to protocol violation). Results are summarized in the table below. rFVIIa Placebo P value No. exposed to blood 2 8 0.037 No. exposed to products 1 5 0.183 No. exposed to any transfusion 2 8 0.037 No. of units exposed median (range) 0 (0–12) 7 (0–27) 0.013 Total drainage (mL) median (range) 240 (140–1000) 630 (240–2320) 0.095 Discussion: rFVIIa significantly reduces transfusion requirements in com- plex cardiac surgery. This supports the positive reported findings of the open label compassionate use of rFVIIa in cardiac surgery. rFVIIa has a well defined place in the management of the haemophiliac patient with inhibitors. This study begins to define possible new indications for its use. Further studies in this area are required. References: 1 Hendriks HG, van der Maaten JM, de Wolf J, et al. An effective treatment of severe intractable bleeding after valve repair by one single dose of activated recombinant factor VII. Anesth. Analg. 2001; 93: 287–289. 2 Al Douri M, Shafi T, Al Khudairi D, et al. Effect of the administration of recombinant activated factor VII (rFVIIa; NovoSeven) in the management of severe uncontrolled bleeding in patients undergoing heart valve replacement surgery. Blood Coagul. Fibrinolysis 2000; 11 (Suppl 1): S121–S127. 078 Pre and postoperative iron status in patients presenting for cardiac surgery M. Steven, I. Quasim, R. Soutar, L. Anderson Department of Anaesthesia, Western Infirmary, Glasgow, Scotland Introduction: The West of Scotland has one of the highest incidences of coronary artery disease in Europe due, in part, to poor diet. It was decided to assess the iron status of our patients as part of our blood use audit with a view to perioperative optimization of iron status. It was hoped not only to assess the proportion of our patients presenting for surgery who were iron deficient but also to assess if those patients had increased red cell require- ments during their hospital stay or had lower discharge haemoglobin (Hb) or lower Hb at 6 weeks. Method: All patients presenting for surgery in our unit have data collected for audit including demographic data, preoperative and discharge Hb, blood and blood product use whilst in hospital and Hb 6 weeks post discharge. Ferritin assay was added to our preoperative work-up and to the 6-week post discharge assessment. Results: While the median ferritin level preoperatively was 117 ng mL -1 , 22% of patients had low (30 ng mL -1 ) or borderline (31–50 ng mL -1 ) ferritin levels. Those with low ferritin levels preoperatively had significantly lower admission Hb (11.8 g dL -1 ) than those with normal levels (13.9 g dL -1 ) using Minitab statistical software; ANOVA where P  0.05. Those with low or bor- derline ferritin were transfused more red cells and had lower discharge Hb than those with normal levels. Six weeks post discharge those with normal ferritin levels had significantly higher Hb (12.8 vs. 11.4 g dL -1 ). The median post discharge ferritin had fallen to 48% of the initial value and almost half of patients now had low or borderline ferritin levels. Of those patients who we considered anaemic (11.0 g dL -1 ) at 6 weeks, 75% had low or borderline ferritin levels preoperatively. Preoperative ferritin levels 50 ng mL -1 (n = 21) 50 ng mL -1 (n = 74) Hb admission (g dL -1 ) 11.8 13.9* Discharge 9.0 9.6 6 weeks 11.4 12.8* Units red cells transfused/patient 2.4 1.0 Discussion: Currently less than 2% of our patients are discharged on iron replacement therapy, largely due to anticipated gastrointestinal upset. Previous work has suggested no benefit in postoperative iron therapy [1] but, in con- trast to our findings, ferritin levels in their control group were within the nor- mal range. Our data suggests that it may be worthwhile discharging all patients on iron, or at least those whose ferritin levels are low preoperatively. Where time permits, there may also be a case for preoperative iron therapy given the significant proportion of our patients who are iron deficient. Since these patients have lower admission Hb and higher red cell demands it may be possible to reduce red cell use. Reference: 1 Crosby L, Palarski VA, Cottington E, et al. Iron supplementation for acute blood loss anemia after coronary artery bypass surgery: a randomized, placebo-controlled study. Heart Lung 1994; 23(6): 493–499. 114 Effects of diclofenac on platelet function and bleeding after cardiac surgery M. Kamenik, I. Osojnik, D. Mekiš Department of Anaesthesiology, Intensive Therapy and Pain Management, Maribor Teaching Hospital, Maribor, Slovenia Introduction: One of the side effects of non steroidal anti-inflammatory drugs (NSAIDs) is the inhibition of platelet aggregation, which could increase bleeding after cardiac surgery [1]. The aim of our study was to analyse the effects of diclofenac on coagulation, platelet function and blood loss after cardiac surgery. Method: In a controlled, blinded, randomized trial we studied 39 patients undergoing elective cardiac surgery using an extracorporeal circuit. Patients were randomly assigned to one of the two treatment groups. The diclofenac (D) group received 75 mg of diclofenac intravenously 3 hours after surgery and the control (C) group received no diclofenac. We registered haemody- namic data and blood loss hourly for 16 hours after surgery. Blood samples for coagulation tests including platelet function were taken before, immedi- ately after, 5 hours after and 16 hours after surgery. Statistical analysis was by ANOVA, Student’s t-test and  2 test. Results: 21 patients were in the D group and 18 patients in the C group. There were no differences between the groups with respect to demographic data, concurrent disease and medication used by the patients. Figure 1. The time course of blood loss within 16 hours after surgery. The time course of blood loss (Figure 1) and the volume of blood lost within 16 hours after surgery were similar in both groups. PTT, aPTT and platelet count decreased significantly after surgery and recovered gradually after 16 hours but no differences were found between the groups. Aggregation of platelets decreased significantly after surgery. After administration of -20 20 60 100 140 180 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 No diclofenac Diclofenac Blood loss (ml) Time (min) Coagulation