Pulmonary EmbolismPhase 4NCT07250763
Therapeutic Initial Heparin Dosing for Patients With Clots or Certain Heart Conditions Admitted to the Hospital
A Phase 4 study testing Initial Heparin Dose Modification in people with Pulmonary Embolism and Deep Vein Thrombosis, run by Inova Health Care Services at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism, Deep Vein Thrombosis, Atrial Fibrillation
- What is being tested?
- Initial Heparin Dose Modification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2023to 31 May 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Inova Alexandria Hospital
Alexandria, Virginia, 22304
About this study
Official title: 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.
Read the 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
- Being tested
- Initial Heparin Dose Modification
- Medical subject headings
- Pulmonary Embolism, Venous Thrombosis, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Initial Heparin Dose ModificationDrug
Also called Use of a patient specific calculator to determine therapeutic dose at initiation of heparin
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)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Initial Heparin Dose Modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 72 hours from infusion initiation
Secondary outcomes (6)
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
Measured: up to 72 hours from infusion initiation
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.
Measured: baseline, through the study completion, an average of 5 days
The Incidence of thrombosis during hospitalization
Number of participants who experience thrombosis during hospitalization
Measured: 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.
Measured: 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
Measured: baseline, through the study completion, an average of 5 days
Mortality during hospitalization
Proportion of participants who die from any cause during hospitalization.
Measured: baseline, through the study completion, an average of 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start20 Sep 2023
- Primary completion28 Feb 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 145 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inova Health Care Services
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07250763
- Sponsor's protocol ID
- U21-08-4517
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 30841720Smythe 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.
PubMed 26780745Granger 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.
PubMed 8598077Hirsh 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.
PubMed 7555181Barletta 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.
PubMed 18586569Riney 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.
PubMed 20587743Fan 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.
PubMed 27646813Shlensky 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.
PubMed 31623539Zifko 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.
PubMed 8856653Raschke 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.
PubMed 8694662
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Intravenous Unfractionated Heparin Starting Infusion Rate for Adult Patients With Deep Vein Thrombosis/Pulmonary Embolism or Cardiac Indications
- ClinicalTrials.gov ID
- NCT07250763
- Acronym / sponsor ID
- U21-08-4517
- Conditions
- Pulmonary Embolism, Deep Vein Thrombosis, Atrial Fibrillation, Acute Cardiac Syndrome, Mechanical Heart Valve Recipients
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 145 participants (estimated)
- Lead sponsor
- Inova Health Care ServicesUniversity, hospital or other
- Study start
- 20 Sep 2023 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 26 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| acute care patients prescribed heparin for treatment of DVT, PE or for conditions such as ACS, Afib | Experimental | Drug: Initial Heparin Dose ModificationThis arm will be participants whose initial dose will be using the patient specific calculator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Initial Heparin Dose ModificationAlso: Use of a patient specific calculator to determine therapeutic dose at initiation of heparinA 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) | Drug | acute care patients prescribed heparin for treatment of DVT, PE or for conditions such as ACS, Afib |
Primary outcome
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.
6 secondary outcomes
Time to first anti-Xa level within goal therapeutic range
Time frame: up to 72 hours from infusion initiation
Change in hemoglobin from baseline
Time frame: 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
Incidence of major bleeding events during hospitalization
Time frame: 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
Mortality during hospitalization
Time frame: baseline, through the study completion, an average of 5 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Background: PubMed 30841720Schurr 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.
- Background: PubMed 26780745Smythe 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.
- Background: PubMed 8598077Granger 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.
- Background: PubMed 7555181Hirsh 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.
- Background: PubMed 18586569Barletta 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.
- Background: PubMed 20587743Riney 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.
- Background: PubMed 27646813Fan 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.
- Background: PubMed 31623539Shlensky 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.
- Background: PubMed 8856653Zifko 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.
- Background: PubMed 8694662Raschke 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Initial Heparin Dose Modification in people with Pulmonary Embolism and Deep Vein Thrombosis, run by Inova Health Care Services at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients with steady-state anti Xa level within goal range (time frame: up to 72 hours from infusion initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07250763, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.