Fetal Loss in Women With Unprovoked Thromboembolism (FLUTE) - Full Text View

Fetal Loss in Women With Unprovoked Thromboembolism (FLUTE)

This study has been terminated.
( Funding withdrawn due to low enrollment )

Sponsors and Collaborators:	Hamilton Health Sciences Canadian Institutes of Health Research (CIHR)
Information provided by:	Hamilton Health Sciences
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, 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

Further study details as provided by Hamilton Health Sciences:

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
First Received:	September 6, 2005
Last Updated:	April 18, 2008
ClinicalTrials.gov Identifier:	NCT00149357
Health Authority:	Canada: Health Canada

Keywords provided by Hamilton Health Sciences:

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 October 14, 2008