Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06329921
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-03-26
First Post:
2024-03-19
Brief Title:
Inpatient Monitoring of Unfractionated Heparin
Sponsor:
Vanderbilt University Medical Center
Organization:
Vanderbilt University Medical Center
Study Overview
Official Title:
Inpatient Monitoring of Unfractionated Heparin
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-07
Last Known Status:
None
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:
None
Brief Summary:
Unfractionated heparin UFH is the most widely used intravenous IV anticoagulant for treating and preventing thromboembolic disease eg blood clots UFH must be closely monitored and adjusted in the hospital There are two assays used to monitor UFH 1 the activated partial thromboplastin time PTT and 2 the chromogenic anti-factor Xa assay anti-Xa This study aims to compare PTT and anti-Xa methods for monitoring UFH in a pragmatic randomized controlled trial to determine which helps patients reach a therapeutic anticoagulation range faster
Detailed Description:
Unfractionated heparin UFH is the most widely used intravenous IV anticoagulant for the treatment and prevention of thromboembolic disease eg blood clots When administered by intravenous injection the onset of action is immediate Indications for use of UFH include venous thromboembolism acute coronary syndrome and acute ischemic stroke UFH is used to prevent thrombosis in the setting of arrhythmias extracorporeal membrane oxygenation ECMO cardiopulmonary bypass CPB and endovascular procedures The unpredictable pharmacokinetics of UFH and interpatient variability result in a narrow therapeutic index restricting its use to the hospital setting with close monitoring and adjustments
Two validated assays exist and are in use at the VUMC adult hospital for the monitoring of unfractionated heparin 1 the activated partial thromboplastin time PTT and 2 the chromogenic anti-factor Xa assay anti-Xa At VUMC the PTT protocol is managed by nursing the anti-Xa protocol is managed by clinical pharmacy Both are clinically acceptable methods for titration and adjustment of unfractionated heparin Assessing the therapeutic effect of unfractionated heparin is most often performed with the PTT which requires institutional calibration to a specific heparin level to account for the variable PTT responses with different commercial reagents and laboratory instruments The PTT can be influenced by various elements during sample processing laboratory analysis and patient biological factors that may cause it to be an inaccurate indication of the degree of anticoagulation This can lead to patients not getting the correct heparin dosing for their clinical needs
The anti-Xa assay is another method of measuring the degree of therapeutic effect of heparin In routine clinical practice the anti-Xa is not as widely available and less familiar among many providers This assay can be impacted by variability in sample collection and processing and laboratory analysis Compared to the PTT assay however it is much less influenced by patient-specific biological factors This may help improve heparin monitoring and titration to ensure patients receive therapeutic levels of anticoagulation and do not get too much or too little heparin However large studies using anti-Xa for management of heparin in the treatment of venous thromboembolism have not been performed
PTT and anti-Xa heparin monitoring protocols have not been compared in a prospective randomized setting The study team will conduct a pragmatic randomized clinical trial comparing the effectiveness of both methods for optimal monitoring of intravenous unfractionated heparin for systemic anticoagulation in hospitalized adult patients
Two validated assays exist and are in use at the VUMC adult hospital for the monitoring of unfractionated heparin 1 the activated partial thromboplastin time PTT and 2 the chromogenic anti-factor Xa assay anti-Xa At VUMC the PTT protocol is managed by nursing the anti-Xa protocol is managed by clinical pharmacy Both are clinically acceptable methods for titration and adjustment of unfractionated heparin Assessing the therapeutic effect of unfractionated heparin is most often performed with the PTT which requires institutional calibration to a specific heparin level to account for the variable PTT responses with different commercial reagents and laboratory instruments The PTT can be influenced by various elements during sample processing laboratory analysis and patient biological factors that may cause it to be an inaccurate indication of the degree of anticoagulation This can lead to patients not getting the correct heparin dosing for their clinical needs
The anti-Xa assay is another method of measuring the degree of therapeutic effect of heparin In routine clinical practice the anti-Xa is not as widely available and less familiar among many providers This assay can be impacted by variability in sample collection and processing and laboratory analysis Compared to the PTT assay however it is much less influenced by patient-specific biological factors This may help improve heparin monitoring and titration to ensure patients receive therapeutic levels of anticoagulation and do not get too much or too little heparin However large studies using anti-Xa for management of heparin in the treatment of venous thromboembolism have not been performed
PTT and anti-Xa heparin monitoring protocols have not been compared in a prospective randomized setting The study team will conduct a pragmatic randomized clinical trial comparing the effectiveness of both methods for optimal monitoring of intravenous unfractionated heparin for systemic anticoagulation in hospitalized adult patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None