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

Inova Health Care Services

Status and phase: Active, not recruiting; Phase 4

Conditions: Pulmonary Embolism; Acute Cardiac Syndrome; Atrial Fibrillation; Deep Vein Thrombosis; Mechanical Heart Valve Recipients

Treatments: Drug: Initial Heparin Dose Modification

Study type: Interventional

Funder types: Other

Identifiers

NCT07250763

U21-08-4517

Details and patient eligibility

About

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.

Full 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.

Enrollment: 145 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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145 participants in 1 patient group

acute care patients prescribed heparin for treatment of DVT, PE or for conditions such as ACS, Afib

Experimental group

Description:

This arm will be participants whose initial dose will be using the patient specific calculator

Treatment:

Drug: Initial Heparin Dose Modification