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Fetal Loss in Women With Unprovoked Thromboembolism (FLUTE)

This study has been terminated.
(Funding withdrawn due to low enrollment)
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00149357
First received: September 6, 2005
Last updated: April 18, 2008
Last verified: April 2008
History of Changes
  Purpose

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.


Condition Intervention
Venous Thromboembolism
Fetal Death
 Other: Thrombophilia Testing

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by McMaster University:

Estimated Enrollment: 1880
Study Start Date: July 2005
Estimated Study Completion Date: April 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
 Other: Thrombophilia Testing
TP testing in Group 1 and 3 only

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Previous VTE in patients with current VTE excluded
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00149357

Locations
Australia, Victoria
Monash Medical Centre
Clayton, Victoria, Australia, 3168
Canada, Ontario
McMaster University Medical Centre
Hamilton, Ontario, Canada, L8N 3Z5
Henderson Research Centre
Hamilton, Ontario, Canada, L8V 1C3
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
St. Joseph's Hospital
Hamilton, Ontario, Canada, L8N 4A6
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Canadian Institutes of Health Research (CIHR)
Investigators
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00149357     History of Changes
Other Study ID Numbers: CTMG-2005-FLUTE
Study First Received: September 6, 2005
Last Updated: April 18, 2008
Health Authority: Canada: Health Canada

Keywords provided by McMaster University:
venous thromboembolism
VTE
thrombophilia
fetal loss

Additional relevant MeSH terms:
Fetal Death
Thromboembolism
Thrombophilia
Venous Thromboembolism
Venous Thrombosis
Pregnancy Complications
Death
 Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis
Hematologic Diseases

ClinicalTrials.gov processed this record on May 22, 2013