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

Study Overview
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Brief Summary
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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.

Official Title
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The Effect on Blood Loss of Topical and Intravenous Tranexamic Acid in Cardiac Surgery Patients: a Randomized Placebo-controlled Trial

Conditions
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Blood Loss, Tranexamic Acid, Cardiac Surgery

Intervention / Treatment
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* Drug: 2 gr tranexamic acid
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gender; male/ female Age: ≥ 18 year Elective cardiac surgical patients Coronary artery bypass graft (CABG) (conventional, E.CCO) Aortic valve replacement (AVR) (conventional) Mitral valve replacement (MVR)/ Mitral valve repairment (MPL) (conventional) Tricuspid valve replacement (TVR) / Tricuspid valve repairment (TPL) Bentall Combined procedure (e.g. CABG/ AVR, MVR/AVR, AVR/Maze) 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: pericardial lavage with 200 ml normothermic saline solution<br>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. | Drug: Saline<br>* This group receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid<br>|
| No Intervention: No pericardial lavage<br>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. In this arm the subjects receives as in standard care no pericardial lavage. | |
| Experimental: 2 gr tranexamic acid diluted in 200 ml normothermic saline<br>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%). | Drug: 2 gr tranexamic acid<br>* This group receives pericardial lavage with 2 gr tranexamic diluted in 200 ml normothermic saline solution (NaCl 0.9%).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Blood Loss | 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 | 12 hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Requiring Surgical Re-exploration | 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. | participants will be followed for the duration of ICU stay, an expected average of 2 days | 
| Total Red Blood Cell Transfusions (Cumulative of Pre, Peri and Postoperative Period) | The amount of red blood cell transfusions the patient receive pre, peri and postoperatively during their stay in the hospital. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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blood loss, tranexamix acid, cardiac surgery