Purpose: This randomized controlled clinical trial compared three dose
s of tranexamic acid (TA) in primary cardiac surgery in terms of blood
loss and transfusion requirements. Methods: Patients presenting for p
rimary coronary artery bypass grafting (CABG) and/or valve replacement
were randomly assigned to one of three TA regimens : 20 mg.kg(-1) (LD
), 50 mg.kg(-1) (MD), and 100 mg.kg(-1) (HD), All participants and sta
ff were blinded to the allocation, Haemoglobin (Hgb), haematocrit and
platelet count were determined preoperatively, after bypass, at CCA ar
rival, and 12 and 24 hr after surgery, Coagulation para meters were me
asured before and after surgery, Blood loss was measured intraoperativ
ely and for 24 hr post operatively following a standardized protocol.
Blood products were administered in a standardized fashion. Results: T
wo hundred twenty patients completed the trial over 10 months: 74 in L
D, 75 in MD and 72 in HD dose groups. All patient groups were comparab
le; similar procedures were performed in each group. No differences we
re identified for blood loss intra-operatively (490 +/- 232 ml, 523 +/
- 413 ml, 488 +/- 357 ml, respectively), 24 hr post-operatively (543 /- 223 ml, 544 +/- 231, 458 +/- 210 ml, respectively), and overall (10
32 +/- 358 ml, 1067 +/- 502 ml, 946 +/- 459 ml, respectively). Blood p
roduct administration was similar in the three groups, No differences
in postoperative complications were found, Conclusions: This study dem
onstrates the equivalency of the three doses of TA in primary cardiac
surgical procedures. The use of low dose (20 mg.kg(-1)) TA results in
comparable outcomes, without additional complications.