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

NCT01895101 | Completed Phase 4 Results DMC

• 2 other identifiers: TA-12512013-000774-30
• Study Type: interventional
• Target: 750
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Loss; Tranexamic Acid; Cardiac Surgery

Keywords

blood loss; tranexamix acid; cardiac surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of Participants Requiring Surgical Re-exploration

  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)

  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

Study Arms (3)

pericardial lavage with 200 ml normothermic saline solution

PLACEBO COMPARATOR

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

No pericardial lavage

NO INTERVENTION

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

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

Interventions

2 gr tranexamic acid DRUG

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

2 gr tranexamic acid diluted in 200 ml normothermic saline

Saline DRUG

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

pericardial lavage with 200 ml normothermic saline solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Amphia Hospital: lead

Study Sites (1)

Amphia Hospital

Breda, 4800 RK, Netherlands

Location

Related Publications (5)

• 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.

  PMID: 23063104 BACKGROUND

• 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.

  PMID: 10694619 BACKGROUND

• 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.

  PMID: 17218108 BACKGROUND

• 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.

  PMID: 16438759 BACKGROUND

• 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.

  PMID: 21660523 BACKGROUND

MeSH Terms

Conditions

Hemorrhage

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Dr. Thierry V Scohy
• Organization: Amphia Hospital

tscohy@amphia.nl

0031765955570

Study Officials

• Thierry Scohy

  Amphia Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, phd

Study Record Dates

• First Submitted: June 25, 2013
• First Posted: July 10, 2013
• Study Start: October 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: May 20, 2015
• Results First Posted: April 10, 2015

Record last verified: 2015-05

Locations

NL (1)