Study Stopped
Funding withdrawn due to low enrollment
Fetal Loss in Women With Unprovoked Thromboembolism (FLUTE)
Determining the Risk of Fetal Loss in Women With Unprovoked Venous Thromboembolism (VTE) Who Do NOT Have Identifiable Inherited Thrombophilia Compared With Women Who Have the Diagnosis of VTE Excluded
1 other identifier
observational
239
2 countries
5
Brief Summary
The purpose of this study is to determine the risk of fetal loss in women with unprovoked venous thromboembolism (VTE) who do not have identifiable inherited thrombophilia compared with women who have the diagnosis of venous thromboembolism (VTE) excluded.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2005
Typical duration for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 6, 2005
CompletedFirst Posted
Study publicly available on registry
September 8, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedMarch 23, 2017
March 1, 2017
2.6 years
September 6, 2005
March 21, 2017
Conditions
Keywords
Study Arms (1)
1, 2 ,3
Group 1 Women with unprovoked VTE and No Known Thrombophilia Group 2 Women who are investigated for VTE and are negative (Control) Group 3 Women with unprovoked VTE who have Thrombophilia
Interventions
Eligibility Criteria
You may qualify if:
- Female
- At least 18 years of age
- Symptomatic for unprovoked venous thromboembolism (deep vein thrombosis \[DVT\] or pulmonary embolism \[PE\])
- At least one pregnancy not terminated intentionally
You may not qualify if:
- Previous VTE in patients with current VTE excluded
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- McMaster Universitylead
- Canadian Institutes of Health Research (CIHR)collaborator
Study Sites (5)
Monash Medical Centre
Clayton, Victoria, 3168, Australia
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2, Canada
McMaster University Medical Centre
Hamilton, Ontario, L8N 3Z5, Canada
St. Joseph's Hospital
Hamilton, Ontario, L8N 4A6, Canada
Henderson Research Centre
Hamilton, Ontario, L8V 1C3, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Huyen Tran, M.D.
McMaster University; Department of Medicine
- PRINCIPAL INVESTIGATOR
Jeffrey Ginsberg, M.D.
McMaster University; Department of Medicine
- PRINCIPAL INVESTIGATOR
Clive Kearon, M.D.
McMaster University; Department of Medicine
- PRINCIPAL INVESTIGATOR
Jim Julian, M.Math
McMaster University; Dept. of Clinical Epidemiology & Biostatistics
- PRINCIPAL INVESTIGATOR
Val Mueller, M.D.
McMaster University; Division of Obstetrics and Gynecology
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2005
First Posted
September 8, 2005
Study Start
July 1, 2005
Primary Completion
February 1, 2008
Study Completion
December 1, 2008
Last Updated
March 23, 2017
Record last verified: 2017-03