Pharmacokinetics of Tranexamic Acid in Patients With Varying Renal Function Undergoing High-risk Cardiac Surgery With the Use of Cardiopulmonary Bypass
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 and urine 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 patients undergoing cardiopulmonary bypass for high-risk cardiac surgery aims to study the pharmacokinetics of TXA in patients with renal dysfunction, compare blood concentration and urine concentration of TXA and its metabolites in patients with and without renal dysfunction and corelate TXA levels during the perioperative periods with other tests of clot formation.
Hypothesis: Standard dosing of TXA used in high-risk cardiac surgery result in higher blood concentration of TXA in patients with renal dysfunction when compared to patients with normal renal function.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Pharmacokinetics of Tranexamic Acid in Patients With Varying Renal Function Undergoing High-risk Cardiac Surgery With the Use of Cardiopulmonary Bypass|
- Tranexamic acid blood concentration [ Time Frame: Baseline, intraoperatively, postoperatively up to 72 hourss ] [ Designated as safety issue: No ]
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
Biospecimen Retention: Samples Without DNA
|Study Start Date:||January 2012|
|Study Completion Date:||March 2016|
|Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01609686
|Toronto General Hospital|
|Toronto, Ontario, Canada, M8X 1W4|