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

NCT01609686 | Completed

• 1 other identifier: 11-0165-B
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Disease; Renal Disease

Keywords

cardiac surgery; renal dysfunction; pharmacokinetics; tranexamic acid

Outcome Measures

Primary Outcomes (1)

• Tranexamic acid blood concentration

  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

  Baseline, intraoperatively, postoperatively up to 72 hourss

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Cardiac surgical patients with chronic renal dysfunction

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, M8X 1W4, Canada

Location

Related Publications (1)

• Jerath A, Yang QJ, Pang KS, Looby N, Reyes-Garces N, Vasiljevic T, Bojko B, Pawliszyn J, Wijeysundera D, Beattie WS, Yau TM, Wasowicz M. Tranexamic Acid Dosing for Cardiac Surgical Patients With Chronic Renal Dysfunction: A New Dosing Regimen. Anesth Analg. 2018 Dec;127(6):1323-1332. doi: 10.1213/ANE.0000000000002724.

  PMID: 29309319 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

Heart Diseases; Kidney Diseases; Renal Insufficiency

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2012
• First Posted: June 1, 2012
• Study Start: January 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: March 1, 2016
• Last Updated: February 3, 2017

Record last verified: 2016-05

Locations

CA (1)