Strategies for Protamine Dosing After Anticoagulation in Cardiovascular Surgery

  • STATUS
    Recruiting
  • End date
    Nov 22, 2021
  • participants needed
    136
  • sponsor
    Fundación Clínica Shaio
Updated on 27 January 2021

Summary

In cardiovascular surgery, patients are anticoagulated with heparin during cardiopulmonary bypass, subsequently, anticoagulation is reversed with protamine to reduce bleeding due to residual heparin-induced coagulopathy, which can last more than four hours. Protamine reverses the effect of heparin by binding to each heparin molecule, therefore an amount of protamine equivalent to residual heparin is required at the time that anticoagulation is desired to be reversed, but generally, the dose of protamine is calculated from the total dose of heparin, ignoring that heparin is metabolized and cleared during of the extracorporeal circulation, this excess of protamine produces anticoagulant effects that increase postoperative bleeding. Residual heparin can be estimated from heparin pharmacokinetic models and therefore, from these models, a dose closer to the amount necessary to reverse the effect of heparin can be estimated, avoiding protamine excess. In this study, a protamine dosage strategy based on residual heparin determined by a pharmacokinetic model of heparin versus total administered heparin will be compared regarding bleeding and use of blood components in the postoperative period.

Details
Condition Anticoagulant Antagonist Toxicity
Treatment Conventional dose, Dosing according residual heparin
Clinical Study IdentifierNCT04628884
SponsorFundación Clínica Shaio
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Do you have Anticoagulant Antagonist Toxicity??
Patients over 18 years of age who undergo scheduled cardiovascular surgery or scheduled urgency at the Shaio clinical foundation in the city of Bogot, who require extracorporeal circulation
ASA classification, between 1 - 4
Informed consent read and signed by the patient
No history of known blood dyscrasia, with INR values <1.5
Platelet count greater than 100,000
No history of heparin-induced thrombocytopenia
No history of adverse reaction to protamine
No use of dual anti-aggregation therapy acetylsalicylic acid (ASA) + ADP receptor inhibitors (Clopidogrel) at the time of surgery
Suspension of ADP receptor inhibitor drugs (Clopidogrel) according to institutional protocol
No use of bridging therapy with tirofiban
Patient with chronic use of oral anticoagulants (warfarin, dabigatran), complete the suspension time according to the institutional protocol
No requirement for renal replacement therapy in the last month
Patient with BMI between 18 - 41 kg / cm2
Not pregnant

Exclusion Criteria

Emergency surgery
Anticoagulated patient at the time of the intervention
Procedure not performed under extracorporeal circulation
Procedure requiring circulatory arrest and / or profound hypothermia
Intraoperative death before protamine administration
Inability to complete data collection
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