Venous ThromboembolismNCT00149357
Fetal Loss in Women With Unprovoked Thromboembolism (FLUTE)
An observational study of Venous Thromboembolism and Fetal Death, run by McMaster University at 5 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Venous Thromboembolism, Fetal Death
- What is being tested?
- Thrombophilia Testing
- How many people
- 239 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Jul 2005to Dec 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Previous VTE in patients with current VTE excluded
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Canada4 sites
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2
McMaster University Medical Centre
Hamilton, Ontario, L8N 3Z5
St. Joseph's Hospital
Hamilton, Ontario, L8N 4A6
Henderson Research Centre
Hamilton, Ontario, L8V 1C3
About this study
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
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.
- Conditions
- Venous Thromboembolism, Fetal Death
- Being tested
- Thrombophilia Testing
- Keywords
- venous thromboembolism, VTE, thrombophilia, fetal loss
- Medical subject headings
- Venous Thromboembolism, Fetal Death, Thrombophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thrombophilia TestingOther
TP testing in Group 1 and 3 only
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Thrombophilia Testing |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startJul 2005
- Primary completionFeb 2008
- Study completionDec 2008
Why it stopped: Funding withdrawn due to low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Huyen Tran, M.D., Study chair, McMaster University; Department of MedicineJeffrey Ginsberg, M.D., Principal investigator, McMaster University; Department of MedicineClive Kearon, M.D., Principal investigator, McMaster University; Department of MedicineJim Julian, M.Math, Principal investigator, McMaster University; Dept. of Clinical Epidemiology & BiostatisticsVal Mueller, M.D., Principal investigator, McMaster University; Division of Obstetrics and Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00149357
- Sponsor's protocol ID
- CTMG-2005-FLUTE
- Status last verified
- Mar 2017
- First submitted
- 6 Sep 2005
- Last updated
- 23 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00149357
- Acronym / sponsor ID
- CTMG-2005-FLUTE
- Conditions
- Venous Thromboembolism, Fetal Death
- Keywords
- venous thromboembolism, VTE, thrombophilia, fetal loss
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Funding withdrawn due to low enrollment
- Enrolment
- 239 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Jul 2005
- Primary completion
- Feb 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 8 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1, 2 ,3 | – | Other: Thrombophilia TestingGroup 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Previous VTE in patients with current VTE excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thrombophilia TestingTP testing in Group 1 and 3 only | Other | 1, 2 ,3 |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Funding withdrawn due to low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huyen Tran, M.D. study chair
McMaster University; Department of Medicine
Jeffrey Ginsberg, M.D. principal investigator
McMaster University; Department of Medicine
Clive Kearon, M.D. principal investigator
McMaster University; Department of Medicine
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thromboembolism and Fetal Death, run by McMaster University at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Funding withdrawn due to low enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2017.