Related Experiment Video

Updated: Feb 7, 2026

Design and Implementation of an fMRI Study Examining Thought Suppression in Young Women with, and At-risk, for Depression
08:42

Design and Implementation of an fMRI Study Examining Thought Suppression in Young Women with, and At-risk, for Depression

Published on: May 19, 2015

11.2K

Design and rationale for the DIVERSITY study: An open-label, randomized study of dabigatran etexilate for pediatric

Manuela Albisetti1, Branislav Biss2, Lisa Bomgaars3

  • 1Hematology Department University Children's Hospital Zürich Switzerland.

Research and Practice in Thrombosis and Haemostasis
|July 27, 2018
PubMed

Insights

This study will evaluate dabigatran etexilate (DE) as a new treatment for pediatric venous thromboembolism (VTE). The trial compares DE to the standard of care to assess its safety and effectiveness in children.

Area of Science:

  • Pediatric Hematology
  • Pharmacology
  • Clinical Trials

Background:

  • Current pediatric venous thromboembolism (VTE) treatments, including unfractionated heparin (UFH) and low-molecular-weight heparin (LMWH), have limitations.
  • Dabigatran etexilate (DE) shows promise for VTE treatment, with established efficacy and safety in adults.
  • Pediatric-specific trials are necessary to determine appropriate dosing and confirm efficacy for DE in children.

Purpose of the Study:

  • To outline the design of a phase IIb/III trial for pediatric VTE.
  • To evaluate a proposed dosing algorithm for dabigatran etexilate (DE) in children.
  • To assess the safety and efficacy of DE compared to the standard of care (SOC) for pediatric VTE.

Main Methods:

  • An open-label, randomized, noninferiority study involving approximately 180 pediatric patients (0 to <18 years) with VTE.
  • Patients will receive either DE or SOC for 3 months, following initial UFH or LMWH treatment.
  • DE will be administered twice daily in age-appropriate formulations (capsules, pellets, or liquid) based on a proposed dosing algorithm.

Main Results:

  • The study will determine the efficacy of DE by assessing complete thrombus resolution, freedom from recurrent VTE, and VTE-related mortality.
  • The safety of DE will be evaluated by measuring freedom from major bleeding events.
  • Two co-primary endpoints will be used to assess both efficacy and safety.

Conclusions:

  • The trial findings are expected to provide crucial data on the effectiveness and safety of dabigatran etexilate (DE) for treating pediatric VTE.
  • This research aims to establish DE as a viable alternative to current treatments for VTE in children.
  • The study is registered on ClinicalTrials.gov (NCT01895777).
Abstract

Keywords:
anticoagulantsdabigatran etexilatedirect thrombin inhibitorspediatricsvenous thromboembolism

More Related Videos

PIP-on-a-chip: A Label-free Study of Protein-phosphoinositide Interactions10:58

PIP-on-a-chip: A Label-free Study of Protein-phosphoinositide Interactions

Published on: July 27, 2017

10.0K
Author Spotlight: Simulating Pediatric Cardiac Surgery Using a Neonatal Piglet Model04:55

Author Spotlight: Simulating Pediatric Cardiac Surgery Using a Neonatal Piglet Model

Published on: May 26, 2023

1.4K

Related Concept Videos

Bioequivalence Experimental Study Designs: Completely Randomized and Randomized Block Designs01:20

Bioequivalence Experimental Study Designs: Completely Randomized and Randomized Block Designs

Body:Bioequivalence experimental study designs are crucial methodologies used in evaluating and comparing the bioavailability of different drug products. These designs are categorized into various types: completely randomized, randomized block, repeated measures, cross and carry-over, and Latin square designs.Completely randomized designs involve randomly allocating treatments to all subjects participating in the experiment. This allocation is achieved by assigning unique random numbers to...
250
Study Design in Statistics01:15

Study Design in Statistics

A study design is a set of techniques that allow a researcher to collect and analyze data from different variables defined for a specific research problem. Statistics is commonly for effective study design and more robust experiments,
Does aspirin reduce the risk of heart attacks? Is one brand of fertilizer more effective at growing roses than another? Is fatigue as dangerous to a driver as the influence of alcohol? Questions like these are answered using randomized experiments with proper...
10.1K
Study Designs in Epidemiology01:20

Study Designs in Epidemiology

Epidemiological study designs are fundamental tools for investigating the distribution, determinants, and control of health conditions in populations. They help researchers understand the relationships between exposures and outcomes, and they broadly fall into two categories: "observational" and "experimental" studies.
Observational studies are those where the researcher does not intervene but rather observes natural variations. They include cross-sectional, cohort, and...
1.0K
Bioavailability Study Design: Single Versus Multiple Dose Studies01:11

Bioavailability Study Design: Single Versus Multiple Dose Studies

Bioavailability studies are essential for understanding how a drug is absorbed, distributed, metabolized, and excreted in the body. These studies assess the extent and rate at which the active pharmaceutical agent becomes available at the site of action. The design of bioavailability studies can involve single-dose or multiple-dose regimens, each with distinct advantages and limitations.Single-dose studies are the preferred approach due to their simplicity and reduced drug exposure for...
249
Venous Thrombosis II: Clinical Manifestations and Diagnostic Studies01:20

Venous Thrombosis II: Clinical Manifestations and Diagnostic Studies

The key difference between Superficial Vein Thrombosis (SVT) and Deep Vein Thrombosis (DVT) lies in their location and severity.Clinical ManifestationsSVT typically presents with localized pain, tenderness, and redness along the course of a superficial vein, often accompanied by a palpable, cord-like structure under the skin. This condition is usually less dangerous than DVT but can be uncomfortable and may lead to complications such as cellulitis or, rarely, a clot extension into the deep...
349
Bioavailability Study Design: Absolute Versus Relative Bioavailability01:27

Bioavailability Study Design: Absolute Versus Relative Bioavailability

Bioavailability is a crucial pharmacokinetic parameter that quantifies the proportion of an administered drug that reaches the systemic circulation and is available for therapeutic action. Regulatory agencies mandate the assessment of bioavailability, typically measured as the area under the drug plasma concentration-versus-time curve (AUC), to ensure the efficacy and safety of pharmaceutical products. These evaluations are categorized as absolute and relative bioavailability studies.Absolute...
365