Pharmacokinetics of Tranexamic Acid in Patients With Varying Renal Function Undergoing Cardiac Surgery With the Use of Cardiopulmonary Bypass

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01609686

Enrollment

Registered

2012-06-01

Start date

2012-01-31

Completion date

2016-03-31

Last updated

2017-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Disease, Renal Disease

Keywords

cardiac surgery, renal dysfunction, pharmacokinetics, tranexamic acid

Brief summary

Cardiopulmonary bypass surgery is associated with extensive blood loss in upto 20% of patients. Tranexamic acid (TXA) is a routinely administered antifibrinolytic agent that reduces blood loss and blood transfusion requirement. However, standard dosing of TXA in patients suffering from renal dysfunction and undergoing cardiopulmonary bypass surgery may lead to higher blood concentration of TXA when compared to the patients with normal renal function. Solid phase microextraction (SPME) is a fast and simple method to measure TXA levels. This prospective study on cadiac surgical patients undergoing cardiopulmonary bypass aims to study the pharmacokinetics of TXA in patients with renal dysfunction. Two patient groups will be studied who will receive either TXA 50mg/kg bolus or BART regimen (30 mg/kg, 16 mg/kg/h + 2 mg/kg pump prime) depending on the type of cardiac surgical procedure and bleeding risk. Hypothesis: Standard dosing of TXA used in cardiac surgery result in higher blood concentration of TXA in patients with renal dysfunction when compared to patients with normal renal function.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Cardiac surgical patients above 18 years of age with renal dysfunction (stage 1, 2 ,3, 4 and 5 of the Kidney Disease Outcome Quality - Initiative classification of chronic kidney disease)

Exclusion criteria

* All patients under 18 years of age or unable to give consent * Documented drug allergy to tranexamic acid * Deep hypothermic circulatory arrest * Pre-existing coagulopathy * Pregnancy * Advanced liver disease * Renal transplant recipients * Concomitant treatment with contraceptives, tretinonin

Design outcomes

Primary

Measure	Time frame	Description
Tranexamic acid blood concentration	Baseline, intraoperatively, postoperatively up to 72 hourss	Sampling schedule for blood TXA concentration Baseline (before administration of TXA) 5 minutes after TXA 10 minutes after TXA Post-sternotomy Before commencing CPB Every 30 mins on Cardiopulmonary bypass (CPB) Off CPB Prior to sternotomy closure Post-operative blood sampling schedule On admission to Intensive Care Unit (ICU) 1, 2, 4, 8, 12, 24, 48 and 72 hours post-op

Countries

Canada

Outcome results