The study was performed to examine a possible augmentation of systemic administration of tranexamic acid by the additional topical application during heart valve surgery in the post-aprotinin era. One-hundred patients were enrolled in the study and all the patients were given tranexamic acid intravenously. The participants were randomized into two groups (A, n = 49; B, n = 51), and before commencing the sternal suturing, the study solution (group A: 250 ml of normal saline + tranexamic acid 2.5 g, placebo group B: 250 ml of normal saline) was poured into the pericardial cavity. The cumulative blood loss (geometric means [95% confidence intervals]) 4 h after the surgery was 86.1 [56.1, 132.2] ml in group A, and 135.4 [94.3, 194.4] in group B, test for equality of geometric means P = 0.107, test for equality of variances P = 0.059. Eight hours after the surgery, the blood loss was 199.4 [153.4, 259.2] ml in group A, 261.7 [205.1, 334.0] ml in group B, P = 0.130 and P = 0.050, respectively. Twenty-four hours postoperatively the blood loss was 504.2 [436.0, 583.0] ml in group A, 569.7 [476.0, 681.7] ml in group B, P = 0.293 and P = 0.014, respectively. The proportion of patients transfused postoperatively by fresh frozen plasma differed significantly between the two study groups (group A: n = 21, group B: n = 36, P = 0.008). Our hypothesis is supported by a significant difference in the inter-group variance of blood loss and the proportion of patients requiring fresh frozen plasma; however evident differences in mean postoperative blood loss were not statistically significant.
Heart valve surgery carries a high risk of renal insufficiency as an independent risk factor due to prolonged cardiopulmonary bypass. Multiple causes of cardiopulmonary bypass-associated renal damage have been described, and haemoglobin-induced renal injury is presently being investigated. Forty-three patients scheduled for heart valve surgery (mostly combined) were enrolled in the prospective study. Plasma free haemoglobin (PFH) levels were evaluated by photocolorimetric measurement at the start of procedures (t(0)) and before the end of extracorporeal circulation (t(1)). A statistically significant increase in PFH levels during cardiopulmonary bypass was detected [median values (interquartile range) - t(0): 62.0 (53.4) mg/L, t(1): 320.4 (352.2) mg/L], P < 0.001. A significant regression relationship between the duration of cardiopulmonary bypass and the increased PFH was found (Spearman's correlation coefficient 0.628, P < 0.001). In some elderly patients, the tendency towards a high release of PFH during cardiopulmonary bypass was more pronounced, but the overall association between age and PFH levels was of borderline significance (P = 0.077). The correlation between PFH and post-operative serum creatinine was low and non-significant, but the latter correlated highly with the pre-operative serum creatinine values (Spearman's correlation coefficient reached values of 0.6-0.7, P < 0.001). Patients were classified according to the Risk of renal failure, Injury to the kidney, Failure of kidney function, Loss of kidney function and End-stage renal failure (RIFLE) classification for acute renal dysfunction during post-operative days 1 - 4; the influence of PFH levels at t(1) on the consequent RIFLE classification was not proven (P=0.648), but 4 patients in the Injury category had shown a higher median value of PFH (433.6 mg/L) in comparison with the others (29 patients with no acute renal dysfunction - 313.7 mg/L, 10 patients at Risk - 330.1 mg/L).
Sixty-five patients scheduled for coronary surgery were randomized into three groups: A - conventional coronary artery bypass grafting, B - off-pump surgery, C - coronary artery bypass grafting with modified, rheoparin coated cardiopulmonary bypass with the avoidance of re-infusion of cardiotomy blood into the circuit. On the completion of peripheral bypass anastomoses, highly significant inter-group differences were found in the thromboelastographic parameter lysis of set time at 60 min of assessment (P=0.003) and at 150 min of assessment (P<0.001), the mean values of these parameters were significantly lower in group A as compared with both groups B and C, which were statistically indistinguishable. Lysis on set time on the completion of peripheral bypass anastomoses <50% was detected in 12 patients (52.2%) originating from group A. At the other sampling times (preoperatively, 15 min after sternotomy, at the end of the procedures, and 24 h later) thromboelastographic parameters were similar in all groups. In group A no significant correlations between lysis on set time, postoperative blood loss and D-dimer levels were found. Based on our results, thromboelastographic signs of fibrinolysis were clearly detectable during cardiopulmonary bypass in group A, but not at any time in groups B and C.
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