Therapeutic Initial Heparin Dosing for Patients With Clots or Certain Heart Conditions Admitted to the Hospital
NCT ID: NCT07250763
Last Updated: 2025-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
145 participants
INTERVENTIONAL
2023-09-20
2027-05-31
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
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)
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Diagnosis of thrombophilia/hypercoagulable state
* Concurrent use of direct-acting oral anticoagulants or low molecular weight heparins
* Baseline anti-Xa \> 0.7
* Pregnancy
18 Years
ALL
No
Sponsors
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Inova Health Care Services
OTHER
Responsible Party
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Locations
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Inova Alexandria Hospital
Alexandria, Virginia, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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U21-08-4517
Identifier Type: -
Identifier Source: org_study_id
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