NCT07250763

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

Optimization of Intravenous Unfractionated Heparin Starting Infusion Rate for Adult Patients With Deep Vein Thrombosis/Pulmonary Embolism or Cardiac Indications

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 145 (estimated)
• Sponsor: Inova Health Care Services · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pulmonary Embolism
• Deep Vein Thrombosis
• Atrial Fibrillation
• Acute Cardiac Syndrome
• Mechanical Heart Valve Recipients

Interventions

Type	Name	Description
DRUG	Initial 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)

Timeline

• Start date: 2023-09-20
• Primary completion: 2027-02-28
• Completion: 2027-05-31
• First posted: 2025-11-26
• Last updated: 2025-11-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study