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

Amphia Hospital

Status and phase: Completed; Phase 4

Conditions: Cardiac Surgery; Tranexamic Acid; Blood Loss

Treatments: Drug: 2 gr tranexamic acid; Drug: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT01895101

2013-000774-30 (EudraCT Number)

TA-1251

Details and patient eligibility

About

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.

Enrollment: 750 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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750 participants in 3 patient groups, including a placebo group

pericardial lavage with 200 ml normothermic saline solution

Placebo Comparator group

Description:

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.

Treatment:

Drug: Saline

No pericardial lavage

No Intervention group

Description:

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.

2 gr tranexamic acid diluted in 200 ml normothermic saline

Experimental group

Description:

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%).

Treatment:

Drug: 2 gr tranexamic acid