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

November 25, 2025 updated by: Inova Health Care Services

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

145

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Alexandria, Virginia, United States, 22304
        • Inova Alexandria Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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)
Other Names:
  • Use of a patient specific calculator to determine therapeutic dose at initiation of heparin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of patients with steady-state anti Xa level within goal range
Time Frame: 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.
up to 72 hours from infusion initiation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first anti-Xa level within goal therapeutic range
Time Frame: 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
up to 72 hours from infusion initiation
Change in hemoglobin from baseline
Time Frame: 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.
baseline, through the study completion, an average of 5 days
The Incidence of thrombosis during hospitalization
Time Frame: baseline, through the study completion, an average of 5 days
Number of participants who experience thrombosis during hospitalization
baseline, through the study completion, an average of 5 days
Incidence of major bleeding events during hospitalization
Time Frame: baseline, through the study completion, an average of 5 days
The number of participants who experience major bleeding events during hospitalization.
baseline, through the study completion, an average of 5 days
Length of stay in acute care setting
Time Frame: baseline, through the study completion, an average of 5 days
Total duration of hospitalization in acute care setting in days
baseline, through the study completion, an average of 5 days
Mortality during hospitalization
Time Frame: baseline, through the study completion, an average of 5 days
Proportion of participants who die from any cause during hospitalization.
baseline, through the study completion, an average of 5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inova Health Care Services

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2023

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

May 31, 2027

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

November 25, 2025

First Posted (Actual)

November 26, 2025

Study Record Updates

Last Update Posted (Actual)

November 26, 2025

Last Update Submitted That Met QC Criteria

November 25, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U21-08-4517

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data obtained through this study may be provided to qualified researchers with academic interest in doing of Heparin Infusions. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.

IPD Sharing Time Frame

The information will become available after publication acceptance has been received. This will be available from 6 months post publication and up to 24 months post publication date.

IPD Sharing Access Criteria

Scientific researchers interested in the study information would need to contact the primary or sub investigator via email. The data requested will be reviewed by the internal research team, any necessary paperwork required at the time by the Inova research team will be shared with the requester. If appropriate paperwork is received by Inova, the data requested will be shared expeditiously

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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