A randomized, double-blind, and placebo-controlled study with tranexamic acid of bleeding and fibrinolytic activity after primary coronary artery bypass grafting

Cardiopulmonary bypass is frequently associated with excessive blood loss. Platelet dysfunction is the main cause of non-surgical bleeding after open-heart surgery. We randomized 65 patients in a double-blind fashion to receive tranexamic acid or placebo in order to determine whether antifibrinolyti...

Full description

Bibliographic Details
Main Authors: A.T.L. Santos, R.A.K. Kalil, C. Bauemann, J.B. Pereira, I.A. Nesralla
Format: Article
Language:English
Published: Associação Brasileira de Divulgação Científica 2006-01-01
Series:Brazilian Journal of Medical and Biological Research
Subjects:
Online Access:http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0100-879X2006000100007
_version_ 1818839427271622656
author A.T.L. Santos
R.A.K. Kalil
C. Bauemann
J.B. Pereira
I.A. Nesralla
author_facet A.T.L. Santos
R.A.K. Kalil
C. Bauemann
J.B. Pereira
I.A. Nesralla
author_sort A.T.L. Santos
collection DOAJ
description Cardiopulmonary bypass is frequently associated with excessive blood loss. Platelet dysfunction is the main cause of non-surgical bleeding after open-heart surgery. We randomized 65 patients in a double-blind fashion to receive tranexamic acid or placebo in order to determine whether antifibrinolytic therapy reduces chest tube drainage. The tranexamic acid group received an intravenous loading dose of 10 mg/kg, before the skin incision, followed by a continuous infusion of 1 mg kg-1 h-1 for 5 h. The placebo group received a bolus of normal saline solution and continuous infusion of normal saline for 5 h. Postoperative bleeding and fibrinolytic activity were assessed. Hematologic data, convulsive seizures, allogeneic transfusion, occurrence of myocardial infarction, mortality, allergic reactions, postoperative renal insufficiency, and reopening rate were also evaluated. The placebo group had a greater postoperative blood loss (median (25th to 75th percentile) 12 h after surgery (540 (350-750) vs 300 (250-455) mL, P = 0.001). The placebo group also had greater blood loss 24 h after surgery (800 (520-1050) vs 500 (415-725) mL, P = 0.008). There was a significant increase in plasma D-dimer levels after coronary artery bypass grafting only in patients of the placebo group, whereas no significant changes were observed in the group treated with tranexamic acid. The D-dimer levels were 1057 (1025-1100) µg/L in the placebo group and 520 (435-837) µg/L in the tranexamic acid group (P = 0.01). We conclude that tranexamic acid effectively reduces postoperative bleeding and fibrinolysis in patients undergoing first-time coronary artery bypass grafting compared to placebo.
first_indexed 2024-12-19T03:54:07Z
format Article
id doaj.art-c7ccc701a7e047b49f393d8392fa7f33
institution Directory Open Access Journal
issn 0100-879X
1414-431X
language English
last_indexed 2024-12-19T03:54:07Z
publishDate 2006-01-01
publisher Associação Brasileira de Divulgação Científica
record_format Article
series Brazilian Journal of Medical and Biological Research
spelling doaj.art-c7ccc701a7e047b49f393d8392fa7f332022-12-21T20:36:52ZengAssociação Brasileira de Divulgação CientíficaBrazilian Journal of Medical and Biological Research0100-879X1414-431X2006-01-01391636910.1590/S0100-879X2006000100007A randomized, double-blind, and placebo-controlled study with tranexamic acid of bleeding and fibrinolytic activity after primary coronary artery bypass graftingA.T.L. SantosR.A.K. KalilC. BauemannJ.B. PereiraI.A. NesrallaCardiopulmonary bypass is frequently associated with excessive blood loss. Platelet dysfunction is the main cause of non-surgical bleeding after open-heart surgery. We randomized 65 patients in a double-blind fashion to receive tranexamic acid or placebo in order to determine whether antifibrinolytic therapy reduces chest tube drainage. The tranexamic acid group received an intravenous loading dose of 10 mg/kg, before the skin incision, followed by a continuous infusion of 1 mg kg-1 h-1 for 5 h. The placebo group received a bolus of normal saline solution and continuous infusion of normal saline for 5 h. Postoperative bleeding and fibrinolytic activity were assessed. Hematologic data, convulsive seizures, allogeneic transfusion, occurrence of myocardial infarction, mortality, allergic reactions, postoperative renal insufficiency, and reopening rate were also evaluated. The placebo group had a greater postoperative blood loss (median (25th to 75th percentile) 12 h after surgery (540 (350-750) vs 300 (250-455) mL, P = 0.001). The placebo group also had greater blood loss 24 h after surgery (800 (520-1050) vs 500 (415-725) mL, P = 0.008). There was a significant increase in plasma D-dimer levels after coronary artery bypass grafting only in patients of the placebo group, whereas no significant changes were observed in the group treated with tranexamic acid. The D-dimer levels were 1057 (1025-1100) µg/L in the placebo group and 520 (435-837) µg/L in the tranexamic acid group (P = 0.01). We conclude that tranexamic acid effectively reduces postoperative bleeding and fibrinolysis in patients undergoing first-time coronary artery bypass grafting compared to placebo.http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0100-879X2006000100007Tranexamic acidCoronary artery bypassPostoperative bleedingClinical trial
spellingShingle A.T.L. Santos
R.A.K. Kalil
C. Bauemann
J.B. Pereira
I.A. Nesralla
A randomized, double-blind, and placebo-controlled study with tranexamic acid of bleeding and fibrinolytic activity after primary coronary artery bypass grafting
Brazilian Journal of Medical and Biological Research
Tranexamic acid
Coronary artery bypass
Postoperative bleeding
Clinical trial
title A randomized, double-blind, and placebo-controlled study with tranexamic acid of bleeding and fibrinolytic activity after primary coronary artery bypass grafting
title_full A randomized, double-blind, and placebo-controlled study with tranexamic acid of bleeding and fibrinolytic activity after primary coronary artery bypass grafting
title_fullStr A randomized, double-blind, and placebo-controlled study with tranexamic acid of bleeding and fibrinolytic activity after primary coronary artery bypass grafting
title_full_unstemmed A randomized, double-blind, and placebo-controlled study with tranexamic acid of bleeding and fibrinolytic activity after primary coronary artery bypass grafting
title_short A randomized, double-blind, and placebo-controlled study with tranexamic acid of bleeding and fibrinolytic activity after primary coronary artery bypass grafting
title_sort randomized double blind and placebo controlled study with tranexamic acid of bleeding and fibrinolytic activity after primary coronary artery bypass grafting
topic Tranexamic acid
Coronary artery bypass
Postoperative bleeding
Clinical trial
url http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0100-879X2006000100007
work_keys_str_mv AT atlsantos arandomizeddoubleblindandplacebocontrolledstudywithtranexamicacidofbleedingandfibrinolyticactivityafterprimarycoronaryarterybypassgrafting
AT rakkalil arandomizeddoubleblindandplacebocontrolledstudywithtranexamicacidofbleedingandfibrinolyticactivityafterprimarycoronaryarterybypassgrafting
AT cbauemann arandomizeddoubleblindandplacebocontrolledstudywithtranexamicacidofbleedingandfibrinolyticactivityafterprimarycoronaryarterybypassgrafting
AT jbpereira arandomizeddoubleblindandplacebocontrolledstudywithtranexamicacidofbleedingandfibrinolyticactivityafterprimarycoronaryarterybypassgrafting
AT ianesralla arandomizeddoubleblindandplacebocontrolledstudywithtranexamicacidofbleedingandfibrinolyticactivityafterprimarycoronaryarterybypassgrafting
AT atlsantos randomizeddoubleblindandplacebocontrolledstudywithtranexamicacidofbleedingandfibrinolyticactivityafterprimarycoronaryarterybypassgrafting
AT rakkalil randomizeddoubleblindandplacebocontrolledstudywithtranexamicacidofbleedingandfibrinolyticactivityafterprimarycoronaryarterybypassgrafting
AT cbauemann randomizeddoubleblindandplacebocontrolledstudywithtranexamicacidofbleedingandfibrinolyticactivityafterprimarycoronaryarterybypassgrafting
AT jbpereira randomizeddoubleblindandplacebocontrolledstudywithtranexamicacidofbleedingandfibrinolyticactivityafterprimarycoronaryarterybypassgrafting
AT ianesralla randomizeddoubleblindandplacebocontrolledstudywithtranexamicacidofbleedingandfibrinolyticactivityafterprimarycoronaryarterybypassgrafting