Blood loss in patients undergoing elective total hip or knee arthroplasty. MedDRA version: 20.1 Level: LLT Classification code 10053220 Term: Hip injury System Organ Class: 100000004863 MedDRA version: 20.1 Level: LLT Classification code 10049032 Term: Knee injury System Organ Class: 100000004863
Conditions
Interventions
Trade Name: Cyklokapron 100 mg/ml Injektionslösung
Pharmaceutical Form: Solution for injection
INN or Proposed INN: TRANEXAMIC ACID
Other descriptive name: TRANEXAMIC ACID
Concentration unit: mg/ml mi
Sponsors
Medical University Vienna
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Undergoing elective total hip or knee arthroplasty under general anaesthesia • Age = 18 years • Written informed consent given Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Allergy to Tranexamic Acid • Acute venous or arterial thrombosis (eg. myocardial infarction, stroke) within the past six months • Renal impairment (eGFR <60 ml/min/1.73 m2) • Untreated or not sufficient treatable convulsions • Pregnancy • Patient not able to understand study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of two different dosing regimens of intravenous Tranexamic Acid during total hip or knee arthroplasty by assessing the total perioperative blood loss from start of surgery until 24 hours after end of surgery.;Secondary Objective: To measure plasma concentrations of TXA will be at 7 different times using ultra-high performance liquid chromatography. Further the correlation of different plasma concentrations of TXA with POC testing of TXA activity, based on EMT using ClotPro, will be assessed. At the same timepoints we will conduct thrombin generation testing. We also assess the total number of units of red blood cells transfused and the occurrence of cardiovascular (e.g. myocardial infarction, thromboembolic events) and neurologic complications (e.g. seizures) from the beginning of TXA administration until 48 h after termination of the continuous TXA infusion.;Primary end point(s): Total perioperative blood loss in millilitre blood.;Timepoint(s) of evaluation of this end point: 24 hours after surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Difference of haemoglobin levels before surgery and 24h after surgery (analysed by an ANCOVA- model). 2. Total amount of units of red blood cells transfused 3. Complications (cardiovascular complications + neurological complications). 4. Plasma Tranexamic Acid concentrations at different timepoints. 5. Results of EMT – ClotPro at the same timepoints 6. Results of ROTEM at the same timepoints 7. Thrombin generation at the same timepoints 8. The correlation of plasma Tranexamic Acid Concentrations and ClotPro/ROTEM results 9. Correlation of plasma Tranexamic Acid Concentrations and Thrombin generation ;Timepoint(s) of evaluation of this end point: 1. Before administration of the TXA bolus dose 2. Immediately (within 5 minutes) after completion of the bolus administration of TXA 3. 1.5 hours after completion of the bolus administration of TXA 4. 5 minutes after the completion of surgery, defined by skin closure 5. 2 hours after termination of the continuous infusions of TXA 6. 24 hours after termination of the continuous infusions of TXA 7. 48 hours after termination of the continuous infusions of TXA | — |
Countries
Austria
Contacts
Public ContactProtocoll Author
Medical University Vienna, Department of Anaesthesia, Intensive Care Medicine and Pain Medicine
Outcome results
None listed