The Effect on Blood Loss of Topical and Intravenous Tranexamic Acid in Cardiac Surgery Patients

Phase 4

Completed

Brief Summary: It remains still unclear whether topical tranexamic acid has an added value besides the administration of intravenously tranexamic acid. We hypothesize that the addition of topical tranexamic acid, besides intravenous administration of tranexamic acid, results in a 25% reduction of post-operative blood loss after cardiac surgery.

The aim of this study is to determine whether the application of topical tranexamic acid reduces the 12 hours postoperative blood loss by 25% in patient scheduled for cardiac surgery on cardiopulmonary bypass, whereby intravenous tranexamic acid is administrated.

Just before sternal closure, 250 subjects receives pericardial lavage with 2 gr tranexamic acid in 200 ml normothermic saline solution (NaCl 0.9%), 250 subjects receives pericardial lavage with 200 ml normothermic saline solution without TA and 250 subjects (control group) receives no pericardial lavage. The main study parameter is 12 hours post-operative blood loss and is assessed by 12 hours post-operative chest tube production.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

MVR/MPL (minimal invasive, Port Access Surgery)
Maze (minimal invasive, via Thoracoscopy)
AVR (minimal invasive, via mini Sternotomy)
off-pump procedures
Emergency operations
Patient with increased or decreased blooding tendency (FV leiden, prot C, S deficiency, anti-thrombin deficiency, prothrombin mutation)

Arm && Interventions

Group	Intervention	Description
pericardial lavage with 200 ml normothermic saline solution	Saline	According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass. This arm also receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid.
2 gr tranexamic acid diluted in 200 ml normothermic saline	2 gr tranexamic acid	According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass. This arm receives also pericardial lavage with 2 gr TA diluted in 200 ml normothermic saline solution (NaCl 0.9%).

Primary Outcome Measures

Name	Time	Method
Postoperative Blood Loss	12 hours postoperative	The primary study parameter is 12 hours postoperative blood loss and is assessed by postoperative chest tube production. Postoperative chest tube production 12 hours after surgical procedure

Secondary Outcome Measures

Name	Time	Method
Number of Participants Requiring Surgical Re-exploration	participants will be followed for the duration of ICU stay, an expected average of 2 days	the secondary objective of this study is to determine whether pericardial lavage with saline gives an improvement in haemostasis, compared with no pericardial lavage, resulting in a reduction of surgical re-explorations and post-operative 12-hour blood loss. The choice for a surgical re-exploration will be decided according to the ICU protocol.
Total Red Blood Cell Transfusions (Cumulative of Pre, Peri and Postoperative Period)	participants will be followed for the duration of ICU stay, an expected average of 2 days/ And participants will be followed for the duration of hospital stay, an expected average of 3 weeks	The amount of red blood cell transfusions the patient receive pre, peri and postoperatively during their stay in the hospital.