Network Platforms

Clinical Trials and Shared Platforms

This platform supports pilot studies to inform the design and conduct of full randomized controlled trials. Pilot studies evaluate the feasibility of recruitment and study procedures, and can inform sample size calculations and study logistics. Pilot data can also be reassuring to funders and grant reviewers and help to secure large-scale funding for collaborative multicenter trials.

Platform initiatives also include efforts aimed at global standardization and quality improvement in VTE research.

The Team

Platform Co-Leads

Deborah Siegal (Ottawa, ON)
Grégoire Le Gal (Ottawa, ON)

Working Group 

Tobias Tritschler (Bern, Switzerland) 

Pilot Studies

Since 2016, CanVECTOR has held annual pilot trial competitions that are open to network members. The research teams include trainees and early career investigators, along with patient partners and established investigators. Applications are reviewed by CanVECTOR patient partners and by peer-reviewers from Canada and members of other national networks (through INVENT-VTE).

See the list of active CanVECTOR funded studies. Click here to learn about the completed CanVECTOR funded studies. 

Standardization and Best Practices in VTE Research

14. Common Data Elements

ISTH VTE CDEs

Common Data Elements for Venous Thromboembolism (ISTH VTE CDE) were presented in The Journal of Thrombosis and Haemostasis as an official communication from the Scientific and Standardization Committee (SSC) of the International Society on Thrombosis and Haemostasis (ISTH). This culminated a year-long international effort to collaboratively create global common research data standards for VTE clinical research. The project’s Steering Committee, including CanVECTOR members Dr. Grégoire Le Gal (Chair), Dr. Lana Castellucci, and Dr. Marc Carrier, oversaw seven Working Groups comprising a team of over 50 international VTE experts. Twelve CanVECTOR members contributed as working group members and many others participated in the public comment period.

Access the ISTH Common Data Elements here.

Publication(s)

  • Le Gal, GCarrier, MCastellucci, LA, et al; for the ISTH CDE Task ForceDevelopment and implementation of common data elements for venous thromboembolism research: Official Communication from the SSC of the ISTHJ Thromb Haemost202119297– 303https://doi.org/10.1111/jth.15138

ASH COVID Toolkit 

 A toolkit including data elements and endpoints related to venous thrombosis, arterial thrombosis, anticoagulation, bleeding, and associated laboratory tests, was published in Blood Advances in December 2020. The toolkit, designed to be easy to use by trialists who are not thrombosis specialists, was a product of The ASH Research Collaborative (ASH RC) and the International Society on Haemostasis and Thrombosis (ISTH), led by Dr. Deborah Siegal, and a team consisting of several CanVECTOR members.

Learn more about the toolkit here

Publication(s)

  • Deborah M. Siegal, Geoffrey D. Barnes, Nicole J. Langlois, Adrienne Lee, Saskia Middeldorp, Leslie Skeith, William A. Wood, Grégoire Le Gal; A toolkit for the collection of thrombosis-related data elements in COVID-19 clinical studies. Blood Adv 2020; 4 (24): 6259–6273. doi: https://doi.org/10.1182/bloodadvances.2020003269

 

15. Standardized Outcomes

PE-related Death

Pulmonary embolism (PE)‐related death is often a component of the primary outcome in venous thromboembolism (VTE) clinical studies. Definitions for PE‐related death vary widely, which may lead to biased risk estimates of clinical outcomes, thereby affecting both internal and external validity of study results. We here provide a standardized definition of PE‐related death and propose guidance for classification and reporting of the cause of death for clinical studies in VTE. The proposal was developed in a four‐step process, including a systematic review of definitions used for PE‐related death in previous studies, two subsequent surveys with VTE experts, and meetings held within the Scientific and Standardization Committee (SSC) working group until consensus on the proposal was reached. The proposed classification comprises three categories:

  • Category A: PE‐related death;
  • Category B: undetermined cause of death, and;
  • category C: cause of death other than PE.

Category A includes A1: autopsy‐confirmed PE in the absence of another more likely cause of death; A2: objectively confirmed PE before death in the absence of another more likely cause of death; and A3: PE is not objectively confirmed, but is most likely the main cause of death. Category B includes B1: cause of death is undetermined, despite available information; and B2: insufficient clinical information available to determine the cause of death. The use of the proposed definition will hopefully improve the accuracy of study outcomes, between‐study comparisons, meta‐analyses, and validity of future clinical VTE studies.

Publication(s)

  • Systematic Review: Kraaijpoel N, Tritschler T, Guillo E, Girard P, Le Gal G. Definitions, adjudication, and reporting of pulmonary embolism-related death in clinical studies: A systematic review. J Thromb Haemost. 2019 Oct;17(10):1590-1607. doi: 10.1111/jth.14570. Epub 2019 Jul 31. PMID: 31301689.
  • Definitions and Methods: Tritschler, T, Kraaijpoel, N, Girard, P, et al Definition of pulmonary embolism‐related death and classification of the cause of death in venous thromboembolism studies: Communication from the SSC of the ISTH. J Thromb Haemost. 2020; 18: 1495– 1500. https://doi.org/10.1111/jth.14769
  • Validation in an Autopsy Cohort: Tritschler, TSalvatore, SPKahn, SR, et al. ISTH definition of pulmonary embolism-related death and classification of the cause of death in venous thromboembolism studies: Validation in an autopsy cohortJ Thromb Haemost2021192514– 2521https://doi.org/10.1111/jth.15458

Establishing an International Core Outcome Set for Clinical Trials of Interventions for Venous Thromboembolism in Adults (VTE-COS)

Blood clots in the veins (called venous thromboembolism or VTE) are common and affect up to 70,000 Canadians per year. This condition can be fatal if a blood clot in the leg or arm travels to the lungs. Treatment mostly relies on anticoagulants (blood thinners), which are very effective but involve risks and inconvenience for patients. Clinical trials are vital for determining the effectiveness of new treatments. Researchers measure outcomes that they believe are important for decision-making. Two problems that we have identified in clinical trials of VTE treatment are: 1) inconsistent measurement of outcomes, and 2) they may not be measuring all outcomes that are important, especially to patients but also to other stakeholders such as policy makers. The development of "core outcome sets" is gaining popularity as a strategy to address these problems. They are an agreed upon collection of standardized outcomes that should be measured and reported for a condition. A variety of perspectives are required to create a useful core outcome set. CanVECTOR, a national VTE research network, plans to involve researchers, clinicians, patients and other stakeholders to decide together on the best outcomes for VTE studies. We will seek input from international groups to develop a core outcome set that is applicable worldwide. Our project has several steps: 1) Review VTE studies to create a comprehensive list of outcomes; 2) Hold small group sessions with patients to identify outcomes that are meaningful to them; 3) Survey a large group of clinicians, researchers, patients and policy makers to prioritize the list of outcomes; 4) Hold a consensus meeting with representatives of each group to decide on the final core outcome set; and 5) Introduce and promote the core outcome set to Canadian and International researchers and stakeholders in our Canadian and global networks.

  1. Inconsistent measurement of outcomes, and
  2. They may not be measuring all outcomes that are important, especially to patients but also to other stakeholders such as policy makers.

The development of "core outcome sets" is gaining popularity as a strategy to address these problems. They are an agreed upon collection of standardized outcomes that should be measured and reported for a condition. A variety of perspectives are required to create a useful core outcome set. CanVECTOR, a national VTE research network, plans to involve researchers, clinicians, patients and other stakeholders to decide together on the best outcomes for VTE studies. We will seek input from international groups to develop a core outcome set that is applicable worldwide. The project has several steps including:

  1. Review VTE studies to create a comprehensive list of outcomes;
  2. Hold small group sessions with patients to identify outcomes that are meaningful to them;
  3. Survey a large group of clinicians, researchers, patients and policy makers to prioritize the list of outcomes;
  4. Hold a consensus meeting with representatives of each group to decide on the final core outcome set;
  5. Introduce and promote the core outcome set to Canadian and International researchers and stakeholders in our Canadian and global networks.

Please visit the project research page for complete details.

COMET Registry

Clinical trials of venous thromboembolism (VTE) treatment in adults suffer from inconsistent measurement of outcomes and they may not be measuring all outcomes that are important, especially to patients and stakeholders. A COS for VTE does not exist as a resource for investigators.

This project is a mixed-methods Core Outcome Set development study with the goal of defining a core set of valid, homogeneous and relevant outcomes for use in clinical trials of interventions for venous thromboembolism in adults, then promoting these outcomes internationally with researchers, knowledge users and all relevant stakeholders.

The scoping review has been registered at the University of Ottawa: http://hdl.handle.net/10393/40459. Learn more.

Publication(s)

  • Tritschler T, Langlois N, Hutton B, et al Protocol for a scoping review of outcomes in clinical studies of interventions for venous thromboembolism in adults BMJ Open 2020;10:e040122. doi: 10.1136/bmjopen-2020-040122

16. Adjudication Platform

Previously, adjudication was done with paper-based forms at face-to-face meetings; this was time consuming, inconvenient, and reduced independent evaluation by dual adjudicators. We developed a web-based adjudication platform called VERDICT that allows adjudicators to do this work on their own time, more efficiently, and with a lower potential for biased interpretation.

Please visit our resources page for complete details.