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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first anti-Xa level within goal therapeutic range | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inova Alexandria Hospital | Alexandria | Virginia | 22304 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30841720 | Background | 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. | |
| 26780745 | 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. |
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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.
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.
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
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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.
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|
|
| Change in hemoglobin from baseline | 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 | 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 | 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 | Total duration of hospitalization in acute care setting in days | baseline, through the study completion, an average of 5 days |
| Mortality during hospitalization | Proportion of participants who die from any cause during hospitalization. | baseline, through the study completion, an average of 5 days |
| 8598077 | 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. |
| 7555181 | 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. |
| 18586569 | 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. |
| 20587743 | 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. |
| 27646813 | 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. |
| 31623539 | 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. |
| 8856653 | 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. |
| 8694662 | 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. |
| ID | Term |
|---|---|
| D011655 | Pulmonary Embolism |
| D020246 | Venous Thrombosis |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013927 | Thrombosis |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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