Acute Cardiac Syndrome, Atrial Fibrillation, Deep Vein Thrombosis, Mechanical Heart Valve Recipients, Pulmonary Embolism
Conditions
Brief summary
The goal of this clinical trial study is to test whether a mathematical calculation, using the patient's gender, weight and kidney function, can better predict a patient's heparin goal dose than a flat number of units per patient weight can. Participants will have the first dose of heparin infusion calculated, after which if adjustments are needed, the Hospital's prebuilt table for results driven dosing for this purpose is used. The researchers will compare the time it takes for the participants to get to the desired goal using the patient's information for calculation versus patients in the past who received the medication using the flat rate. The hypothesis is that the patients with enhanced personal data, gender, weight and kidney function, included for the initial dose, will get to their goal lab value sooner and with less chance of delay or overshooting the goal. A quicker time to goal lab value is beneficial to patients in many ways, including earlier treatment of the clot or coronary issue that the patient is experiencing.
Detailed description
Heparin infusions are high-risk medications that must be titrated to effect within a narrow therapeutic anti-Xa range. Prolonging the time to reach the therapeutic range decreases the clinical effectiveness of the infusion and increases the potential for adverse drug events. The intervention used in this study will be calculating the initial heparin infusion rates described below rather than dosing 18 units/kg/hr for the moderate-intensity protocol and 12 units/kg/hr with a dose cap of 1000 units/hr for the low-intensity protocol. Moderate-Intensity Protocol (R2 = 0.48) Heparin infusion rate (unit/(kg\*hr))=(1004.8-163.5\*(1 if female)-4.8\*(age in years)+14.6\*(actual body weight in kg)-19.3\*(BMI in kg/m\^2))/(Actual body weight in kg) Low-Intensity Protocol (R2 = 0.31) Heparin infusion rate (unit/(kg\*hr))=(615.5-70.1\*(1 if female)-1.7\*(age in years)+10.1\*(actual body weight in kg)-11.9\*(BMI in kg/m\^2))/(Actual body weight in kg) All other components of heparin infusion management will be conducted per Inova Health System standard of care.
Interventions
DRUGInitial Heparin Dose Modification
A patient specific initial therapeutic dose calculator will be used to start the heparin drip. The aim is to start the patient on a dose that is or is close to the therapeutic dose - one that gets the patient to the goal outcome (lab value driven)
Sponsors
Inova Health Care Services
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Retrospective chart review and data was used to develop a dosing equation that uses patient specific factors. Results of intervention group will be compared to the retrospective group.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years-old * Diagnosis by the attending physician with one of the following conditions for which anticoagulation with heparin in an Food & Drug Administration approved indication and considered the standard of care: * Moderate-intensity anti-Xa protocol: new-onset deep vein thrombosis or pulmonary embolism, or mechanical heart valve * Low-intensity anti-Xa protocol: atrial fibrillation, acute cardiac syndrome, embolic stroke * Heparin infusion either has not started or has been initiated in the last 120 minutes
Exclusion criteria
* Use of extracorporeal membrane oxygenation or ventricular assist devices such as Impella pumps * Diagnosis of thrombophilia/hypercoagulable state * Concurrent use of direct-acting oral anticoagulants or low molecular weight heparins * Baseline anti-Xa \> 0.7 * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of patients with steady-state anti Xa level within goal range | up to 72 hours from infusion initiation | The proportion of patients who have a heparin infusion charted as administered for at least 6 hours who achieve at least one steady state anti-Xa level in the goal range. A steady state anti-Xa level is defined as an anti-Xa level drawn a minimum of 6 hours since the last titration or bolus dose was charted as administered. The goal anti-Xa range is defined as 0.3 to 0.7 for the moderate-intensity protocol and 0.3 to 0.5 for the low-intensity protocol. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in hemoglobin from baseline | baseline, through the study completion, an average of 5 days | Absolute change in the measurement of the hemoglobin from start of the heparin infusion throughout the inpatient stay to see if the decrease is a delta of \>2gm/dL. Events of \>2g/dL will be summarized separately. |
| The Incidence of thrombosis during hospitalization | baseline, through the study completion, an average of 5 days | Number of participants who experience thrombosis during hospitalization |
| Time to first anti-Xa level within goal therapeutic range | up to 72 hours from infusion initiation | time from first heparin infusion administration to the first anti-Xa level within the therapeutic range. Therapeutic ranges are as defined to moderate and low intensity protocols. Variability across participants will be summarized using a standard deviation |
| Length of stay in acute care setting | baseline, through the study completion, an average of 5 days | Total duration of hospitalization in acute care setting in days |
| Mortality during hospitalization | baseline, through the study completion, an average of 5 days | Proportion of participants who die from any cause during hospitalization. |
| Incidence of major bleeding events during hospitalization | baseline, through the study completion, an average of 5 days | The number of participants who experience major bleeding events during hospitalization. |
Countries
United States
Outcome results
None listed