Therapeutic Initial Heparin Dosing for Patients With Clots or Certain Heart Conditions Admitted to the Hospital

Phase 4Active Not RecruitingNCT07250763

Inova Health Care Services145 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

The proportion of patients with steady-state anti Xa level within goal range

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.

Time frame: up to 72 hours from infusion initiation

Secondary Outcomes

Time to first anti-Xa level within goal therapeutic range

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

Time frame: up to 72 hours from infusion initiation

Change in hemoglobin from baseline

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.