What side effects are associated with this type of intervention?

Common treatments for blood clots include anticoagulants such as warfarin, heparin, and newer oral anticoagulants like dabigatran, apixaban, and rivaroxaban. The known side effects of these treatments can include bleeding complications, such as gastrointestinal bleeding and intracranial hemorrhage. Other side effects may include anemia, thrombocytopenia, and, in some cases, liver enzyme abnormalities. Patients on these medications may also experience minor side effects like nausea, dizziness, and rash. It is important for patients to be monitored regularly to manage and mitigate these risks.

What prior FDA approvals exist?

The FDA has approved several anticoagulants for the treatment of blood clots, including low molecular weight heparins (LMWH) like enoxaparin, and direct oral anticoagulants (DOACs) such as apixaban, rivaroxaban, and edoxaban. These treatments are often used in conjunction with diagnostic tests like D-Dimer assays to assess clot presence and risk. The LumiraDx Point of Care D-Dimer and CRP Tests are part of this diagnostic approach, helping to guide the use of these anticoagulant therapies by providing rapid and accurate measurement of D-Dimer levels, which are indicative of clot formation and breakdown in the body.

What other types of research exist?

Promising novel alternatives to LumiraDx Point of Care D-Dimer and CRP tests for blood clot patients include: 1) High-sensitivity D-Dimer assays, which offer improved accuracy and faster results. 2) Multiplex biomarker panels that simultaneously measure D-Dimer, CRP, and other relevant biomarkers, providing a comprehensive assessment of thrombotic risk. 3) Advanced point-of-care devices utilizing microfluidics and lab-on-a-chip technology for rapid and precise testing. These innovations aim to enhance diagnostic accuracy, reduce turnaround time, and improve patient outcomes.

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Blood collection for Blood Clot (NOVEL-3 Trial)

N/A

Waitlist Available

Led By Judith Kirstein

Research Sponsored by LumiraDx UK Limited

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects must be >18 years of age

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 months

Awards & highlights

NOVEL-3 Trial Summary

This trial looked at whether the results of two point-of-care tests for blood clotting and inflammation were comparable to those of reference laboratory tests.

Who is the study for?

This trial is for adults over 18 who have symptoms of infection, inflammation, or blood clots and are seeking medical attention. They must be willing to consent and comply with study procedures. Excluded are those with skin conditions preventing blood draws, on recent anticoagulants or experimental drugs, critically ill, or in end-of-life care.Check my eligibility

What is being tested?

The trial tests the accuracy of LumiraDx Point of Care D-Dimer and CRP Tests using fingerstick and venepuncture methods against a reference analyzer. It aims to see if these quick bedside tests agree with standard lab results in various clinical conditions.See study design

What are the potential side effects?

Since this trial involves common blood collection methods like fingersticks and venepuncture rather than drug interventions, side effects may include minor pain at the puncture site, bruising, bleeding, or fainting during the blood draw.

NOVEL-3 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am older than 18 years.

NOVEL-3 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Assessment of sample matrix comparison

NOVEL-3 Trial Design

1Treatment groups

Experimental Treatment

Group I: Blood collectionExperimental Treatment2 Interventions

Venepuncture and fingerstick to obtain venous blood and capillary blood respectively

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Venepuncture

2018

N/A

~790

Fingerstick

2021

N/A

~420

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for blood clots include anticoagulants such as direct oral anticoagulants (DOACs), low-molecular-weight heparin (LMWH), and warfarin. DOACs, like rivaroxaban and apixaban, inhibit specific clotting factors (Factor Xa or thrombin), preventing clot formation. LMWH works by enhancing the activity of antithrombin III, which inhibits thrombin and Factor Xa. Warfarin inhibits vitamin K-dependent clotting factors. These treatments are crucial for blood clot patients as they prevent clot progression and recurrence, reducing the risk of complications such as post-thrombotic syndrome. Diagnostic tests for D-Dimer and CRP levels help monitor treatment efficacy and detect inflammation or clot presence, guiding therapeutic decisions.

Investigation of the Molecular Mechanism of Coagulopathy in Severe and Critical Patients With COVID-19.Effect of rosuvastatin on risk markers for venous thromboembolism in cancer.Review article: Coagulation cascade and therapeutics update: relevance to nephrology. Part 1: Overview of coagulation, thrombophilias and history of anticoagulants.