Ignite Creation Date:
2024-05-06 @ 3:24 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04628884
Status:
UNKNOWN
Last Update Posted:
2020-12-01
First Post:
2020-11-09
Brief Title:
Strategies for Protamine Dosing After Anticoagulation in Cardiovascular Surgery
Sponsor:
Fundación Clínica Shaio
Organization:
Fundación Clínica Shaio
Study Overview
Official Title:
Comparison of Two Strategies for Protamine Dosing After Anticoagulation in Cardiovascular Surgery Regarding Postoperative Bleeding Total Heparin Administered Versus Residual Heparin Determined by a Pharmacokinetic Model
Status:
UNKNOWN
Status Verified Date:
2020-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SEPARATION
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None