BACKGROUND:Pharmacologic intervention to minimize postbypass bleeding and blood product transfusions has received increasing attention for both medical and economic reasons. METHODS:Two hundred ten patients were entered into a double-blinded, prospective, randomized study to receive either 10 g of fibrinolytic inhibitor tranexamic acid before incision (n = 104) or 250 mL of placebo saline solution (n = 106). All subjects requiring cardiopulmonary bypass were deemed suitable, including those having first-time coronary bypass grafting, valve replacement, and reoperation. RESULTS: There were no statistically significant differences between the groups with respect to demographic or operative characteristics. The tranexamic acid group had a 48% reduction in 24-hour blood drainage (p < 0.001) and received 69% fewer total units of packed red blood cells, 83% fewer total units of plasma, and 75% fewer platelet transfusion units than controls. Only 13 of 104 tranexamic acid patients received blood products versus 33 of 106 controls (p < 0.001). The incidences of thrombotic complications, perioperative myocardial infarction, renal failure, and neurologic complications were not significantly different between the two groups. The tranexamic acid group had 0% mortality versus 1.9% for controls (not significant). CONCLUSIONS:Tranexamic acid is safe and effective in reducing blood loss and blood use in a wide variety of cardiac surgical patients.
RCT Entities:
BACKGROUND: Pharmacologic intervention to minimize postbypass bleeding and blood product transfusions has received increasing attention for both medical and economic reasons. METHODS: Two hundred ten patients were entered into a double-blinded, prospective, randomized study to receive either 10 g of fibrinolytic inhibitor tranexamic acid before incision (n = 104) or 250 mL of placebo saline solution (n = 106). All subjects requiring cardiopulmonary bypass were deemed suitable, including those having first-time coronary bypass grafting, valve replacement, and reoperation. RESULTS: There were no statistically significant differences between the groups with respect to demographic or operative characteristics. The tranexamic acid group had a 48% reduction in 24-hour blood drainage (p < 0.001) and received 69% fewer total units of packed red blood cells, 83% fewer total units of plasma, and 75% fewer platelet transfusion units than controls. Only 13 of 104 tranexamic acidpatients received blood products versus 33 of 106 controls (p < 0.001). The incidences of thrombotic complications, perioperative myocardial infarction, renal failure, and neurologic complications were not significantly different between the two groups. The tranexamic acid group had 0% mortality versus 1.9% for controls (not significant). CONCLUSIONS:Tranexamic acid is safe and effective in reducing blood loss and blood use in a wide variety of cardiac surgical patients.
Authors: David A Henry; Paul A Carless; Annette J Moxey; Dianne O'Connell; Barrie J Stokes; Dean A Fergusson; Katharine Ker Journal: Cochrane Database Syst Rev Date: 2011-03-16
Authors: Karin Pm van Galen; Eveline T Engelen; Evelien P Mauser-Bunschoten; Robert Jj van Es; Roger Eg Schutgens Journal: Cochrane Database Syst Rev Date: 2019-04-19