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OpenTrials
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NCT Number: NCT01609686

Pharmacokinetics of Tranexamic Acid in Patients With Varying Renal Function Undergoing 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 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.

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Key information

Conditions

Cardiac Disease Cardiovascular Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Kidney Diseases Male Urogenital Diseases Renal Disease Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Toronto General Hospital

Toronto, Ontario, M8X 1W4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Tranexamic acid blood concentration

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Jun 1, 2012
Registry last updated
Feb 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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