Monitoring Methods for Blood Clots

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Overseen ByBenjamin Tillman, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Vanderbilt University Medical Center
Must be taking: Unfractionated heparin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods to monitor unfractionated heparin (UFH), a common blood-thinning treatment for preventing and treating blood clots. Researchers aim to determine whether the PTT test or the anti-Xa test helps patients achieve the optimal blood-thinning level more quickly. Participants will be randomly assigned to one of these monitoring methods. This trial suits patients at Vanderbilt University Hospital admitted for observation or inpatient care and prescribed UFH.

As an unphased trial, this study allows patients to contribute to important research that could enhance monitoring methods for blood-thinning treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on monitoring a specific blood thinner, unfractionated heparin, in the hospital.

What prior data suggests that these monitoring methods are safe for patients?

A previous study found that bleeding and clotting rates were similar for unfractionated heparin (UFH) when monitored with either the anti-Xa or PTT methods. The anti-Xa method enabled patients to reach the optimal blood-thinning level more quickly, allowing doctors to determine the correct dose faster.

In contrast, the PTT method often delayed patients from reaching the desired range in the initial days, complicating early dose adjustments.

Overall, both methods monitor UFH, a common and widely accepted treatment. Research suggests that both methods are equally safe, with similar rates of bleeding and clotting.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to improve how we monitor blood clot treatments using heparin. Current protocols often rely on PTT (partial thromboplastin time) to guide dosing, but this trial compares it with an anti-Xa protocol, which directly measures the activity of the blood thinner. The anti-Xa protocol might offer more precise control over heparin levels, potentially leading to better patient outcomes with fewer complications. By comparing these two monitoring methods, researchers hope to identify a more effective way to manage and prevent blood clots, ultimately enhancing patient care.

What evidence suggests that these monitoring methods are effective for managing blood clots?

Research shows that unfractionated heparin (UFH) effectively prevents and treats blood clots by making it harder for the blood to form clots, which is crucial for conditions like deep vein thrombosis and pulmonary embolism. Studies indicate that UFH is safe and effective with careful monitoring. In this trial, participants will be monitored using either the activated partial thromboplastin time (PTT) blood test or the chromogenic anti-factor Xa assay (anti-Xa). Some research suggests that monitoring with the anti-Xa test may lead to fewer dosage changes and tests compared to the PTT test.678910

Who Is on the Research Team?

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Benjamin Tillman, MD

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

This trial is for hospitalized patients who need intravenous anticoagulation with unfractionated heparin to treat or prevent blood clots. Specific eligibility criteria are not provided, but typically participants would be adults without conditions that could interfere with the study.

Inclusion Criteria

Baseline PTT value is ≥0 and ≤ 36.0 seconds
Baseline heparin level anti-Xa assay value is ≥0 and ≤0.3
I am 18 or older and admitted to Vanderbilt University Hospital for treatment that includes IV heparin.

Exclusion Criteria

I need blood thinners due to a special heart-lung machine use or a stroke.
Provider determines patient is not appropriate for the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants are monitored using either the anti-Xa or PTT protocol for optimal monitoring of intravenous unfractionated heparin

5-7 days
Daily monitoring in hospital

Follow-up

Participants are monitored for safety and effectiveness after treatment, including incidence of new thrombotic and bleeding events

48 hours post-treatment

What Are the Treatments Tested in This Trial?

Interventions

  • Unfractionated Heparin
Trial Overview The trial compares two methods of monitoring the effectiveness of heparin: the PTT protocol and the anti-Xa protocol. It aims to find out which method helps patients reach the desired level of blood thinning more quickly.
How Is the Trial Designed?
2Treatment groups
Active Control
Group I: Active Comparator: anti-Xa protocolActive Control1 Intervention
Group II: Active Comparator: PTT protocolActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials
922
Recruited
939,000+

Published Research Related to This Trial

Unfractionated heparin (UFH) has been used for over 50 years to treat and prevent thrombosis, but its variable composition and unpredictable pharmacokinetics limit its effectiveness and complicate monitoring.
Newer anticoagulants, such as low-molecular-weight heparins and direct thrombin inhibitors, offer more predictable effects and eliminate the risk of heparin-induced thrombocytopenia (HIT), making them preferable alternatives to UFH.
Challenges in variation and responsiveness of unfractionated heparin.Francis, JL., Groce, JB.[2019]

Citations

Heparin - StatPearls - NCBI BookshelfUnfractionated heparin is an anticoagulant used for the prevention and treatment of thrombotic events, including deep vein thrombosis, pulmonary ...
Management of Therapeutic-intensity Unfractionated HeparinThe authors concluded that the heparin assay is a safe and effective method, for monitoring heparin treatment in patients with acute VTE whose aPTT remains ...
Lack of standardization of anti‐Xa activity reagentsRosborough T.K.. Monitoring unfractionated heparin therapy with antifactor Xa activity results in fewer monitoring tests and dosage changes than monitoring ...
Fixed-Dose Subcutaneous Low-Molecular-Weight Heparin ...The updated systematic review and meta-analysis discussed here compared the effectiveness and safety of LMWH versus UFH in the initial management of VTE.
A Review of Unfractionated Heparin and Its MonitoringThis article reviews the pharmacology, pharmacokinetic, and pharmacodynamic parameters of unfractionated heparin (UFH); current clinical uses and common ...
Monitoring of Unfractionated Heparin Therapy in the Intensive ...A comparative, longitudinal observational study with laboratory-based aPTT and anti-XA activity measurement.
Comparison of clinical outcomes using activated partial ...Pooled data comparing aPTT vs. anti-Xa for monitoring therapeutic UFH did not suggest differences in the outcomes of bleeding or thrombosis.
8.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/23386070/
Discordant aPTT and anti-Xa values and outcomes in ...Patients with relatively high aPTT to anti-Xa values appear to be at increased risk of adverse outcomes. Monitoring both aPTT and Xa values may ...
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.
Comparison of clinical outcomes using activated partial ...Pooled data comparing aPTT vs. anti-Xa for monitoring therapeutic UFH did not suggest differences in the outcomes of bleeding or thrombosis.
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