Fetal Loss in Women With Unprovoked Thromboembolism (FLUTE)

This study has been terminated.

Sponsors and Collaborators:	Hamilton Health Sciences Canadian Institutes of Health Research (CIHR)
Information provided by:	McMaster University
ClinicalTrials.gov Identifier:	NCT00149357

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

Genetics Home Reference related topics: factor V Leiden thrombophilia

U.S. FDA Resources

Study Type:	Observational
Study Design:	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

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

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

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

Keywords provided by McMaster University:

venous thromboembolism
VTE
thrombophilia
fetal loss

Study placed in the following topic categories:

Embolism and Thrombosis
Death
Pregnancy Complications
Embolism
Thrombophilia

Vascular Diseases
Venous Thromboembolism
Thrombosis
Thromboembolism
Fetal Death

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009