Point-of-care Measurement of the Antifibrinolytic Activity of Tranexamic Acid in Cardiac Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tranexamic acid bolus 20 mg/kg, Tranexamic acid bolus 10 mg/kg, Tranexamic acid bolus 1 mg/kg, Tranexamic acid continuous infusion of 1 mg/kg/h in the low dose group.
- Who it may be relevant to
- Registry conditions: Antifibrinolytic Agents. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Tranexamic acid (TXA) is a widely used antifibrinolytic agent that can reduce postoperative blood loss and packed red blood cell transfusions during cardiac surgery. Previous (in-vivo) studies have measured TXA plasma concentration and associated clinical effect (e.g. blood loss). Patient blood management guidelines recommend the routine use of TXA in cardiac surgery, especially for procedures with a high risk of bleeding. A new point-of-care viscoelastic diagnostic assay (tissue plasminogen activator assay, TPA assay) allows for a rapid determination of antifibrinolytic activity in a patient in the operating room making TXA dose adjustment easily possible intraoperatively. Currently, there is no consensus on the dosing of TXA and different protocols are used. Recommendations for high doses (e.g. 30 mg/kg followed by 16 mg/kg per hour during cardiac surgery with 2 mg/kg added to extracorporeal circulation) alternate with recommendations for low doses (e.g., 10 mg/kg followed by 1 mg/kg per hour for 12 hours). Tranexamic acid administration increases the risk of postoperative seizure, a risk that appears to be dose dependant. A recent meta-analysis suggests that a single TXA bolus of 20 mg/kg is sufficient to reduce postoperative blood loss and packed red blood cell transfusion in patients undergoing aortocoronary bypass surgery. The calculations in the meta-analysis were, however, based on a simulation of blood concentrations of TXA by a pharmacokinetic model, so the results are subject to many uncertainties. The optimal TXA regimen for cardiac surgery, both in terms of efficacy and safety therefore remains uncertain and requires further investigation. This study was invented to determine the actual levels of tranexamic acid in vivo to observe antifibrinolytic activity during cardiac surgery up to 48 hours after termination of surgery. The risk category is evaluated as risk category A as the study is a clinical trial examining the effect of drugs that are already authorized for the clinical use.
Interventions
- Drug Tranexamic acid bolus 20 mg/kg
Bolus of tranexamic acid in the standard dose group - Drug Tranexamic acid bolus 10 mg/kg
Bolus of tranexamic acid in the low dose group - Drug Tranexamic acid bolus 1 mg/kg
Bolus of tranexamic acid in the low dose group (to add into the CPB prime) - Drug Tranexamic acid continuous infusion of 1 mg/kg/h in the low dose group
Tranexamic acid continuous infusion during the procedure
Primary outcome measures
- TPA test [Time frame: 48 hours after completion of surgery]
Secondary outcome measures (1)
- Chromatography [Time frame: 48 hours after completion of surgery]
Eligibility criteria
Inclusion criteria
Eligible patients:
- Over 18 years old
- Elective surgery
- Written informed consent
- Patient planned for aortocoronary artery bypass graft surgery, aortic valve replacement or mitral valve surgery (or a combination of these procedures)
- Normal renal function
- No previous intake of anticoagulants except acetylsalicylic acid in the preoperative period
Exclusion criteria
- Impaired renal function (eGFR < 30 ml/min.)
- History of seizure
- Pregnancy
- Inability to understand and sign the informed consent (e.g., language problems, dementia, psychological disorders)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Switzerland · 1 center
- Dpt. Anesthesiology and pain Medicine — Bern
Identifiers
NCT: NCT06128330 · 2022-02070