Fetal Loss in Women With Unprovoked Thromboembolism (FLUTE)

NCT ID: NCT00149357

Last Updated: 2017-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

239 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-07-31

Study Completion Date

2008-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Venous Thromboembolism Fetal Death

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Thrombophilia Testing

Intervention Type OTHER

TP testing in Group 1 and 3 only

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Thrombophilia Testing

TP testing in Group 1 and 3 only

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

McMaster University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Huyen Tran, M.D.

Role: STUDY_CHAIR

McMaster University; Department of Medicine

Jeffrey Ginsberg, M.D.

Role: PRINCIPAL_INVESTIGATOR

McMaster University; Department of Medicine

Clive Kearon, M.D.

Role: PRINCIPAL_INVESTIGATOR

McMaster University; Department of Medicine

Jim Julian, M.Math

Role: PRINCIPAL_INVESTIGATOR

McMaster University; Dept. of Clinical Epidemiology & Biostatistics

Val Mueller, M.D.

Role: PRINCIPAL_INVESTIGATOR

McMaster University; Division of Obstetrics and Gynecology

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Monash Medical Centre

Clayton, Victoria, Australia

Site Status

Hamilton General Hospital

Hamilton, Ontario, Canada

Site Status

McMaster University Medical Centre

Hamilton, Ontario, Canada

Site Status

St. Joseph's Hospital

Hamilton, Ontario, Canada

Site Status

Henderson Research Centre

Hamilton, Ontario, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Australia Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CTMG-2005-FLUTE

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Below Knee DVT Study
NCT03805672 TERMINATED PHASE4
Thrombin Generation in Neonates
NCT00165906 COMPLETED