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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

750 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2015-03-31

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.

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Detailed Description

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Conditions

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Blood Loss Tranexamic Acid Cardiac Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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pericardial lavage with 200 ml normothermic saline solution

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.

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

This group receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid

No pericardial lavage

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

2 gr tranexamic acid diluted in 200 ml normothermic 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 receives also pericardial lavage with 2 gr TA diluted in 200 ml normothermic saline solution (NaCl 0.9%).

Group Type EXPERIMENTAL

2 gr tranexamic acid

Intervention Type DRUG

This group receives pericardial lavage with 2 gr tranexamic diluted in 200 ml normothermic saline solution (NaCl 0.9%).

Interventions

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2 gr tranexamic acid

This group receives pericardial lavage with 2 gr tranexamic diluted in 200 ml normothermic saline solution (NaCl 0.9%).

Intervention Type DRUG

Saline

This group receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid

Intervention Type DRUG

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No