Clinical Trials Logo

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.


Clinical Trial Description

n/a


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


NCT number NCT01895101
Study type Interventional
Source Amphia Hospital
Contact
Status Completed
Phase Phase 4
Start date October 2013
Completion date March 2015

See also
  Status Clinical Trial Phase
Recruiting NCT05054179 - Pecto-Intercostal Fascial Plane Block Catheter Trial for Reduction of Sternal Pain Phase 2/Phase 3
Completed NCT04051021 - Non-Pharmacological Interventions on Patient Experience and Healthcare Utilization in Adult Cardiac Surgery Patients N/A
Recruiting NCT04604886 - The Consistency of Cardiac Output Measured by Pulmonary Artery Catheter and LiDCO in Cardiac Surgical Patients N/A
Recruiting NCT04075981 - Prevention Atrial Fibrillation by BOTulinum Toxin Injections (BOTAF) Phase 3
Completed NCT04062396 - Comparison of Remowell 2 and Inspire on Delirium and Cognitive Dysfunction N/A
Recruiting NCT04709705 - DMSO Cryopreserved Platelets in Cardiopulmonary Bypass Surgery (CRYPTICS) Phase 2/Phase 3
Not yet recruiting NCT05563662 - SURgical Registry of ENDocarditis EuRope
Withdrawn NCT03289104 - Improving Sternal Healing After Cardiac Surgery: Sternal Wire vs ZIPFIX N/A
Completed NCT04199039 - Effects of Endotracheal Tube Fixation Methods on Hemodynamic Parameters During Endotracheal Suction N/A
Completed NCT03563196 - Diagnosis Of Pulmonary Complications After Cardiac Surgery In Children
Completed NCT02964026 - Study of Clinical Outcomes Associated With the Pulmonary Artery Catheter (PAC) in Cardiac Surgery Patients N/A
Completed NCT02471001 - The Levels of Anaesthetics in Heart Muscle During Heart Surgery N/A
Completed NCT02325726 - RRI Compared With NephroCheckTM to Predict Acute Renal Failure After Cardiac Surgery. N/A
Completed NCT01246947 - Tricuspid Annuloplasty for Moderate Tricuspid Regurgitation Associated With Miral Operation N/A
Completed NCT01151254 - Comparison of Propofol Based Versus Volatile Based Anesthesia and Postoperative Sedation N/A
Completed NCT00821262 - Sevoflurane in Cardiac Surgery Phase 4
Completed NCT00996099 - Continuous Glucose Monitoring Combined With Computer Algorithm for Intensive Insulin Therapy in Cardiosurgical Patients N/A
Completed NCT00617955 - Effects of Aprotinin During Cardiac Surgery/Long Term Death Rates N/A
Completed NCT00336466 - The Erythropoietin NeuroProtective Effect: Assessment in CABG Surgery (TENPEAKS) Phase 2
Completed NCT00337805 - Double Blind Randomized Trial of Saline vs Pentaspan for Resuscitation After Cardiac Surgery Phase 2/Phase 3