Heparin Dosing for Blood Clots and Heart Conditions

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Inova Health Care Services

Must be taking: Heparin

Must not be taking: Direct-acting anticoagulants

Disqualifiers: Pregnancy, Thrombophilia, ECMO, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: up to 72 hours

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if using personal information such as gender, weight, and kidney function can help doctors more accurately determine the right dose of heparin for treating blood clots and certain heart issues. Heparin prevents clots from worsening. The trial will compare this personalized approach to the usual method of dosing based solely on weight. Individuals with conditions like a new blood clot, atrial fibrillation, or acute coronary syndrome who have just started or are about to start heparin treatment might be suitable for this trial. The goal is to reach the right medication level faster, potentially leading to quicker and more effective treatment. As a Phase 4 trial, this research focuses on understanding how this FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

The trial requires that you do not use direct-acting oral anticoagulants or low molecular weight heparins while participating. If you are on these medications, you would need to stop them to join the trial.

What is the safety track record for the initial heparin dose modification?

Research has shown that heparin is a well-known and commonly used medication for thinning the blood. It helps prevent blood clots in conditions like deep vein thrombosis (DVT) and pulmonary embolism (PE). Studies have found that heparin is generally safe when used correctly. Regular blood tests are crucial to adjust the dose and avoid bleeding problems. Most people handle these adjustments well with close monitoring.

In this trial, researchers calculate heparin doses using personal information such as gender, weight, and kidney function. This approach ensures the dose is as accurate as possible from the start. Adjusting doses in this manner is expected to be safe, as heparin is already widely used in hospitals for similar conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the initial Heparin dose modification because it uses a patient-specific calculator to determine the ideal dosage. Unlike the standard approach, which often relies on a one-size-fits-all dosing strategy, this method tailors the dosage to each individual's needs, potentially improving safety and effectiveness. By customizing the dose, it aims to reduce the risk of complications and enhance the overall treatment outcome for conditions like deep vein thrombosis (DVT), pulmonary embolism (PE), and heart conditions such as acute coronary syndrome (ACS) and atrial fibrillation (Afib).

What evidence suggests that this dosing method is effective for blood clots and heart conditions?

Research has shown that heparin effectively prevents and treats blood clots, such as deep vein thrombosis (DVT) and pulmonary embolism (PE). Studies indicate that low-dose heparin can reduce the risk of these clots and fatal PE by 60% to 70%. Hospitals use unfractionated heparin for its ability to prevent these dangerous clots. However, traditional dosing sometimes fails to reach the optimal treatment level in the first 24–48 hours. This trial aims to improve dosing by considering a patient's personal details, such as gender, weight, and kidney function, which may help participants reach the desired treatment level faster and reduce risks. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for hospital patients with conditions like clots, certain heart issues (atrial fibrillation or heart attack), and those who have had a heart valve replacement. They'll receive heparin, a blood thinner. The study aims to personalize the initial dose based on gender, weight, and kidney function rather than using a standard dose.

Inclusion Criteria

I am older than 18 years.

My doctor diagnosed me with a condition that requires heparin.

I have a new deep vein thrombosis, pulmonary embolism, or a mechanical heart valve.

Exclusion Criteria

Use of extracorporeal membrane oxygenation or ventricular assist devices such as Impella pumps

Baseline anti-Xa > 0.7

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive heparin infusion with dosing calculated based on gender, weight, and kidney function

up to 72 hours

Continuous monitoring during hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 days

Daily monitoring during hospital stay

What Are the Treatments Tested in This Trial?

Interventions

• Initial Heparin Dose Modification

Trial Overview Researchers are testing if calculating the first heparin dose with personal data (gender, weight, kidney function) is more effective than a one-size-fits-all approach. They're looking at how quickly patients reach their target blood thinning levels compared to past methods.

How Is the Trial Designed?

Group I: acute care patients prescribed heparin for treatment of DVT, PE or for conditions such as ACS, Afib Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Inova Health Care Services

Lead Sponsor

Trials

80

Recruited

22,700+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07250763?term=heart+disease

Therapeutic Initial Heparin Dosing for Patients With Clots ... The intervention used in this study will be calculating the initial heparin infusion rates described below rather than dosing 18 units/kg/hr ...

2. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK538247/

Heparin - StatPearls - NCBI Bookshelf Unfractionated heparin is an anticoagulant used for the prevention and treatment of thrombotic events, including deep vein thrombosis, pulmonary ...

3. ahajournals.org ahajournals.org/doi/10.1161/01.cir.103.24.2994

Guide to Anticoagulant Therapy: Heparin | Circulation Low-dose heparin reduces the risk of venous thrombosis and fatal PE by 60% to 70%.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12103460/

Optimizing the Dosing of Heparin for Therapeutic ... A recent retrospective study compared standard-intensity heparin (18 u/kg/h) in 219 patients to low-intensity heparin (12 u/kg/h) in 158 ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2666602223000745

Therapeutic inefficacy of protocol driven intravenous ... This study reports that a vast majority of patients remain outside of therapeutic aPTT within first 24–48 h when anticoagulated with UFH.

6. reference.medscape.com reference.medscape.com/drug/calciparine-monoparin-heparin-342169

Heparin dosing, indications, interactions, adverse effects, ... When using a full-dose heparin regimen, adjust heparin dose based on frequent blood coagulation tests; if coagulation test is unduly prolonged or if hemorrhage ...

7. drugs.com drugs.com/dosage/heparin.html

Heparin Dosage Guide + Max Dose, Adjustments Detailed Heparin dosage information for adults and children. Includes dosages for Prevention of Thromboembolism in Atrial Fibrillation, Deep ...