Leadership & Volunteers
ISTH assembled a project Steering Committee composed of over 50 VTE clinical research experts for this project, with attention taken to ensure fair representation by region, gender, and clinical focus areas. The Steering Committee’s charge included establishing the project’s framework and scope, and overseeing the work of seven Working Groups focusing on specific content areas within the CDEs. The Working Groups met once monthly via teleconference over a six month period to first identify key CDEs for their respective topic areas, and then develop definitions and data standards using existing clinical research studies and CRFs as a guide.
VTE CDE Steering Committee
Chair: Dr. Gregoire Le Gal, Ottawa Hospital Research Institute, Canada
Dr. Adam Cuker, University of Pennsylvania, United States
Prof. Marc Righini, Geneva University Hospital, Switzerland
Dr. Lana Castellucci, The Ottawa Hospital, Canada
Dr. Marc Carrier, The Ottawa Hospital, Canada
Dr. Erik Klok, LUMC, Netherlands
Dr. Jerrold Levy, Duke University Medical Center, United States
Prof. John-Bjarne Hansen, The Arctic University of Norway, Norway
Prof. Saskia Middeldorp, Amsterdam UMC, Netherlands
Working Groups
Anticoagulation and Other Therapies
Therapies for treatment and primary and secondary prevention of VTE
Lead: Dr. Adam Cuker, University of Pennsylvania, United States
Prof. Jonathan Douxfils, University of Namur, Belgium
Dr. Leslie Skeith, University of Calgary, Canada
Dr. Lisa Bauman Kreuziger, Blood Center of Wisconsin, United States
Dr. Neil Zakai, University of Vermont, United States
Dr. Nicoletta Riva, University of Malta, Malta
Prof. Peter Verhamme, University of Leuven, Belgium
Prof. Sam Schulman, McMaster University, Canada
Chronic VTE and Functional Outcomes
The definition of outcomes in chronic VTE, including functional outcomes, quality of life, chronic thromboembolism (e.g. post-thrombotic syndrome, CTEPH), and monitoring and diagnostic mechanisms for chronic VTE
Lead: Dr. Erik Klok, LUMC, Netherlands
Dr. Arina Ten Cate-Hoek, Maastricht University Medical Centre, Netherlands
Dr. Irene Lang, MedUniWien, Austria
Prof. Stavros Konstantinides, University Medical Center Mainz, Germany
Dr. Susan Kahn, Jewish General Hospital, Canada
Dr. Waleed Ghanima, Yystfold hospital, Norway
Dr Jean-Philippe Galanaud, Sunnybrook Hospital, Toronto, Canada
Diagnosis of VTE
Diagnostic studies and clinical prediction rules commonly used to diagnose VTE, including imaging studies, ultrasound, pulmonary angiography, probability and prognostic rules, and standardizing the definition of confirmed DVT/PE
Lead: Prof. Marc Righini, Geneva University Hospital, Switzerland
Dr. Char Witmer, The Children’s Hospital of Philadelphia (CHOP), United States
Dr. Erik Klok, LUMC, Netherlands
Dr. Esteban Gandara, The Ottawa Hospital, Canada
Prof. Paolo Prandoni, Arianna Foundation on Anticoagulation, Italy
Dr. Thomas Moumneh, Centre Hospitalier Universitaire d'Angers | CHU Angers, France
General Core Data Elements
Foundational common data elements in the following categories: (1) demographics; (2) history; (3) physical examination; (4) adverse events; (5) protocol deviations; and (5) study discontinuations
Lead: Dr. Lana Castellucci, The Ottawa Hospital, Canada
Dr. Alejandro Lazo-Langner, University of Western Ontario, Canada
Dr. Cynthia Wu, University Of Alberta Hospital, Canada
Dr. Fionnuala Ni Ainle, Rotunda Hospital, Ireland
Dr. Helia Robert-Ebadi, Geneva University Hospitals and Faculty of Medicine, Switzerland
Malignancy
Cancer-associated thrombosis, including active cancer definitions, VTE-related mortality in the context of cancer, cancer-specific VTE risks, and cancer-specific treatments for VTE
Lead: Dr. Marc Carrier, The Ottawa Hospital, Canada
Dr. Cihan Ay, Medical University of Vienna, Austria
Dr. Gabriela Cesarman Maus, National Cancer Institute, Mexico
Dr. Jeffrey Zwicker, Beth Israel Deaconess Med Ctr / Harvard Med School, United States
Dr. Mandy Lauw, Amsterdam UMC/Erasmus MC, Netherlands
Prof. Pantep Angchaisuksiri, Ramathibodi Hospital, Mahidol University, Thailand
Dr. Tzu-Fei Wang, The Ohio State University, United States
Perioperative
Pre-surgical, surgical, and post-surgical aspects of VTE (including post-acute ICU), including arterial thrombosis, bridging anticoagulation, and surgical risk stratification
Lead: Dr. Jerrold Levy, Duke University Medical Center, United States
Dr. Alex Spyropoulos, Northwell Health at Lenox Hill Hospital, United States
Dr. David Faraoni, Hospital for Sick Children, Univ of Toronto, Canada
Dr. Jean Connors, Brigham and Womens Hosp/Harvard Medical School, United States
Prof. Marc Samama, Cochin University Hospital, France
Dr. Marie Steiner, University of Minnesota, United States
Dr. Raquel Bartz, Duke University Medical Center, United States
Prof. Toshiaki Iba, Juntendo University, Japan
Predictors of VTE
Transient and permanent risk factors specific to patients with VTE, including genetic, environmental, and acquired predictors, and comorbidities
Lead: Prof. John-Bjarne Hansen, The Arctic University of Norway, Norway
Dr. Clive Kearon, Juravinski Hospital Clinic, Canada
Dr. Fernanda Orsi, Hospital das Clínicas da Unicamp, Brazil
Prof. Pierre Morange, CHU Timone, France
Dr. Sigrid Brækkan, Unversity of Tromso, Norway
Prof. Suzanne Canniegeter, Leiden University Medical Center, Netherlands
Dr. Vania Morelli, Unviersity of Tromso, Brazil