Optimization of Intravenous Unfractionated Heparin Starting Infusion Rate for Adult Patients With Deep Vein Thrombosis/Pulmonary Embolism or Cardiac Indications
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 145
- 试验地点
- 1
- 主要终点
- The proportion of patients with steady-state anti Xa level within goal range
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
acute care patients prescribed heparin for treatment of DVT, PE or for conditions such as ACS, Afib
This arm will be participants whose initial dose will be using the patient specific calculator
干预措施: Initial Heparin Dose Modification (Drug)
结局指标
主要结局
The proportion of patients with steady-state anti Xa level within goal range
时间窗: 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.
次要结局
- Time to first anti-Xa level within goal therapeutic range(up to 72 hours from infusion initiation)
- Change in hemoglobin from baseline(baseline, through the study completion, an average of 5 days)
- The Incidence of thrombosis during hospitalization(baseline, through the study completion, an average of 5 days)
- Incidence of major bleeding events during hospitalization(baseline, through the study completion, an average of 5 days)
- Length of stay in acute care setting(baseline, through the study completion, an average of 5 days)
- Mortality during hospitalization(baseline, through the study completion, an average of 5 days)