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Phase 4 N=750 Randomized Quadruple-blind Treatment

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

Blood Loss · Tranexamic Acid · Cardiac Surgery

Enrolled (actual)
750
Serious AEs
2.0%
Results posted
Apr 2015
Primary outcome: Primary: Postoperative Blood Loss — 290; 300; 290 ml

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
2 gr tranexamic acid (Drug); Saline (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Amphia Hospital
Primary completion
Mar 2015

Outcome Measures

OutcomeResultp-value
PRIMARY
Postoperative Blood Loss
290; 300; 290
SECONDARY
Number of Participants Requiring Surgical Re-exploration
10; 9; 12
SECONDARY
Total Red Blood Cell Transfusions (Cumulative of Pre, Peri and Postoperative Period)
0.7; 1.1; 0.7

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)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01895101). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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