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

Cardiac Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01895101
• Other study ID #: TA-1251
• Secondary ID: 2013-000774-30
• Status: Completed
• Phase: Phase 4
• First received: June 25, 2013
• Last updated: May 1, 2015
• Start date: October 2013
• Est. completion date: March 2015

Study information

• Verified date: May 2015
• Source: Amphia Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: The Netherlands: Central Committee on Research Involving Human Subjects
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 750
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood Loss
• Cardiac Surgery
• Hemorrhage
• Tranexamic Acid

Intervention

Drug:
• 2 gr tranexamic acid
This group receives pericardial lavage with 2 gr tranexamic diluted in 200 ml normothermic saline solution (NaCl 0.9%).
• Saline
This group receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid

Locations

Country	Name	City	State
Netherlands	Amphia Hospital	Breda

Sponsors (1)

Lead Sponsor	Collaborator
Amphia Hospital

Country where clinical trial is conducted

Netherlands, 

References & Publications (5)

Abul-Azm A, Abdullah KM. Effect of topical tranexamic acid in open heart surgery. Eur J Anaesthesiol. 2006 May;23(5):380-4. Epub 2006 Jan 27. — View 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. Epub 2007 Jan 10. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No