title: Local and systemic application of tranexamic acid in heart valve surgery: a prospective, randomized, double blind LOST study.
abstract: 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.
authors.affiliation: Department of Cardiac Surgery, Third Faculty of Medicine, Charles University Prague and University Hospital Kralovske Vinohrady, Srobarova 50, Prague, Czech Republic.
authors.forename: Jan
authors.initials: J
authors.lastname: Spegar
authors.forename: Tomas
authors.initials: T
authors.lastname: Vanek
authors.forename: Jana
authors.initials: J
authors.lastname: Snircova
authors.forename: Richard
authors.initials: R
authors.lastname: Fajt
authors.forename: Zbynek
authors.initials: Z
authors.lastname: Straka
authors.forename: Petra
authors.initials: P
authors.lastname: Pazderkova
authors.forename: Marek
authors.initials: M
authors.lastname: Maly
mesh_terms: D000368:Aged; D000933:Antifibrinolytic Agents / Q000008:administration & dosage*; D016913:Blood Component Transfusion; D006348:Cardiac Surgical Procedures; D004311:Double-Blind Method; D005260:Female; D006351:Heart Valves / Q000601:surgery*; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D019106:Postoperative Hemorrhage / Q000628:therapy*; D011446:Prospective Studies; D013997:Time Factors; D014148:Tranexamic Acid / Q000008:administration & dosage*
chemical_list: D000933:Antifibrinolytic Agents; D014148:Tranexamic Acid