Clinical trial NCT01895101: The Effect on Blood Loss of Topical and Intravenous Tranexamic Acid in Cardiac Surgery Patients
Official title: The Effect on Blood Loss of Topical and Intravenous Tranexamic Acid in Cardiac Surgery Patients: a Randomized Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Blood Loss
Tranexamic Acid
Cardiac Surgery
Keywords: blood loss
tranexamix acid
cardiac surgery
Lead sponsor: Amphia Hospital
Sponsor class: OTHER
First posted: 2013-07-10
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Postoperative Blood Loss
timeFrame: 12 hours postoperative
Secondary outcomes:
measure: Number of Participants Requiring Surgical Re-exploration
timeFrame: participants will be followed for the duration of ICU stay, an expected average of 2 days
measure: Total Red Blood Cell Transfusions (Cumulative of Pre, Peri and Postoperative Period)
timeFrame: 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
Other outcomes:
Locations:
city: Breda
country: Netherlands
facility: Amphia Hospital
Study officials:
affiliation: Amphia Hospital
name: Thierry Scohy
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mahaffey R, Wang L, Hamilton A, Phelan R, Arellano R. A retrospective analysis of blood loss with combined topical and intravenous tranexamic acid after coronary artery bypass graft surgery. J Cardiothorac Vasc Anesth. 2013 Feb;27(1):18-22. doi: 10.1053/j.jvca.2012.08.004. Epub 2012 Oct 10.
citation: De Bonis M, Cavaliere F, Alessandrini F, Lapenna E, Santarelli F, Moscato U, Schiavello R, Possati GF. Topical use of tranexamic acid in coronary artery bypass operations: a double-blind, prospective, randomized, placebo-controlled study. J Thorac Cardiovasc Surg. 2000 Mar;119(3):575-80. doi: 10.1016/s0022-5223(00)70139-5.
citation: Baric D, Biocina B, Unic D, Sutlic Z, Rudez I, Vrca VB, Brkic K, Ivkovic M. Topical use of antifibrinolytic agents reduces postoperative bleeding: a double-blind, prospective, randomized study. Eur J Cardiothorac Surg. 2007 Mar;31(3):366-71; discussion 371. doi: 10.1016/j.ejcts.2006.12.003. Epub 2007 Jan 10.
citation: Abul-Azm A, Abdullah KM. Effect of topical tranexamic acid in open heart surgery. Eur J Anaesthesiol. 2006 May;23(5):380-4. doi: 10.1017/S0265021505001894. Epub 2006 Jan 27.
citation: Spegar J, Vanek T, Snircova J, Fajt R, Straka Z, Pazderkova P, Maly M. Local and systemic application of tranexamic acid in heart valve surgery: a prospective, randomized, double blind LOST study. J Thromb Thrombolysis. 2011 Oct;32(3):303-10. doi: 10.1007/s11239-011-0608-3.