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

NCT07250763 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: U21-08-4517
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 72 hours from infusion initiation

Secondary Outcomes (6)

• 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

Study Arms (1)

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

EXPERIMENTAL

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

Drug: Initial Heparin Dose Modification

Interventions

Initial Heparin Dose Modification DRUG

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)

Also known as: Use of a patient specific calculator to determine therapeutic dose at initiation of heparin

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Inova Health Care Services: lead

Study Sites (1)

Inova Alexandria Hospital

Alexandria, Virginia, 22304, United States

Location

Related Publications (10)

• Schurr JW, Muske AM, Stevens CA, Culbreth SE, Sylvester KW, Connors JM. Derivation and Validation of Age- and Body Mass Index-Adjusted Weight-Based Unfractionated Heparin Dosing. Clin Appl Thromb Hemost. 2019 Jan-Dec;25:1076029619833480. doi: 10.1177/1076029619833480.

  PMID: 30841720 BACKGROUND

• Smythe MA, Priziola J, Dobesh PP, Wirth D, Cuker A, Wittkowsky AK. Guidance for the practical management of the heparin anticoagulants in the treatment of venous thromboembolism. J Thromb Thrombolysis. 2016 Jan;41(1):165-86. doi: 10.1007/s11239-015-1315-2.

  PMID: 26780745 BACKGROUND

• Granger CB, Hirsch J, Califf RM, Col J, White HD, Betriu A, Woodlief LH, Lee KL, Bovill EG, Simes RJ, Topol EJ. Activated partial thromboplastin time and outcome after thrombolytic therapy for acute myocardial infarction: results from the GUSTO-I trial. Circulation. 1996 Mar 1;93(5):870-8. doi: 10.1161/01.cir.93.5.870.

  PMID: 8598077 BACKGROUND

• Hirsh J, Raschke R, Warkentin TE, Dalen JE, Deykin D, Poller L. Heparin: mechanism of action, pharmacokinetics, dosing considerations, monitoring, efficacy, and safety. Chest. 1995 Oct;108(4 Suppl):258S-275S. doi: 10.1378/chest.108.4_supplement.258s. No abstract available.

  PMID: 7555181 BACKGROUND

• Barletta JF, DeYoung JL, McAllen K, Baker R, Pendleton K. Limitations of a standardized weight-based nomogram for heparin dosing in patients with morbid obesity. Surg Obes Relat Dis. 2008 Nov-Dec;4(6):748-53. doi: 10.1016/j.soard.2008.03.005. Epub 2008 Jun 30.

  PMID: 18586569 BACKGROUND

• Riney JN, Hollands JM, Smith JR, Deal EN. Identifying optimal initial infusion rates for unfractionated heparin in morbidly obese patients. Ann Pharmacother. 2010 Jul-Aug;44(7-8):1141-51. doi: 10.1345/aph.1P088. Epub 2010 Jun 29.

  PMID: 20587743 BACKGROUND

• Fan J, John B, Tesdal E. Evaluation of heparin dosing based on adjusted body weight in obese patients. Am J Health Syst Pharm. 2016 Oct 1;73(19):1512-22. doi: 10.2146/ajhp150388.

  PMID: 27646813 BACKGROUND

• Shlensky JA, Thurber KM, O'Meara JG, Ou NN, Osborn JL, Dierkhising RA, Mara KC, Bierle DM, Daniels PR. Unfractionated heparin infusion for treatment of venous thromboembolism based on actual body weight without dose capping. Vasc Med. 2020 Feb;25(1):47-54. doi: 10.1177/1358863X19875813. Epub 2019 Oct 18.

  PMID: 31623539 BACKGROUND

• Zifko UA, Slomka PJ, Reid RH, Young GB, Remtulla H, Bolton CF. The cortical representation of somatosensory evoked potentials of the phrenic nerve. J Neurol Sci. 1996 Aug;139(2):197-202.

  PMID: 8856653 BACKGROUND

• Raschke RA, Gollihare B, Peirce JC. The effectiveness of implementing the weight-based heparin nomogram as a practice guideline. Arch Intern Med. 1996 Aug 12-26;156(15):1645-9.

  PMID: 8694662 BACKGROUND

MeSH Terms

Conditions

Pulmonary Embolism; Venous Thrombosis; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thrombosis; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Retrospective chart review and data was used to develop a dosing equation that uses patient specific factors. Results of intervention group will be compared to the retrospective group.

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 26, 2025
• Study Start: September 20, 2023
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• 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.
• 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

Locations

US (1)