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Fetal Loss in Women With Unprovoked Thromboembolism (FLUTE)

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ClinicalTrials.gov Identifier: NCT00149357
Recruitment Status : Terminated (Funding withdrawn due to low enrollment)
First Posted : September 8, 2005
Last Update Posted : March 23, 2017
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
McMaster University

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.

Condition or disease Intervention/treatment
Venous Thromboembolism Fetal Death Other: Thrombophilia Testing

Study Type : Observational
Actual Enrollment : 239 participants
Observational Model: Cohort
Time Perspective: Other
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
Study Start Date : July 2005
Actual Primary Completion Date : February 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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




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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00149357


Locations
Australia, Victoria
Monash Medical Centre
Clayton, Victoria, Australia, 3168
Canada, Ontario
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
McMaster University Medical Centre
Hamilton, Ontario, Canada, L8N 3Z5
St. Joseph's Hospital
Hamilton, Ontario, Canada, L8N 4A6
Henderson Research Centre
Hamilton, Ontario, Canada, L8V 1C3
Sponsors and Collaborators
McMaster University
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

Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT00149357     History of Changes
Other Study ID Numbers: CTMG-2005-FLUTE
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: March 23, 2017
Last Verified: March 2017

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

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