Fetal Loss in Women With Unprovoked Thromboembolism (FLUTE)

Venous Thromboembolism Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00149357
• Other study ID #: CTMG-2005-FLUTE
• Status: Terminated
• Phase: N/A
• First received: September 6, 2005
• Last updated: March 21, 2017
• Start date: July 2005
• Est. completion date: December 2008

Study information

• Verified date: March 2017
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 239
• Est. completion date: December 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fetal Death
• Thromboembolism
• Thrombophilia
• Venous Thromboembolism

Intervention

Other:
• Thrombophilia Testing
TP testing in Group 1 and 3 only

Locations

Country	Name	City	State
Australia	Monash Medical Centre	Clayton	Victoria
Canada	Hamilton General Hospital	Hamilton	Ontario
Canada	Henderson Research Centre	Hamilton	Ontario
Canada	McMaster University Medical Centre	Hamilton	Ontario
Canada	St. Joseph's Hospital	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	Canadian Institutes of Health Research (CIHR)

Countries where clinical trial is conducted

Australia,  Canada,