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NCT Number: NCT01895101

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

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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Key information

Conditions

Blood Loss Cardiac Surgery Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Tranexamic Acid

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Amphia Hospital

Breda, 4800 RK, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

2 gr tranexamic acid

Drug

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

Saline

Drug

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

Primary outcomes

  1. Postoperative Blood Loss

    Time frame: 12 hours postoperative

    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

Secondary outcomes

  1. Number of Participants Requiring Surgical Re-exploration

    Time frame: participants will be followed for the duration of ICU stay, an expected average of 2 days

    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.

  2. Total Red Blood Cell Transfusions (Cumulative of Pre, Peri and Postoperative Period)

    Time frame: 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

    The amount of red blood cell transfusions the patient receive pre, peri and postoperatively during their stay in the hospital.

Sponsors and collaborators

Lead sponsor

Amphia Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jul 10, 2013
Registry last updated
May 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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