BridgeMD
New treatment option for Active Cancer and Symptomatic or Incidental Pulmonary Embolism Without...
Official title Home Treatment of Patients With Active Cancer and Acute Pulmonary Embolism Without HESTIA Criteria.
ClinicalTrials.gov ID: NCT07315347
What this study is testing
- What it's testing
- Main objective of this multisite randomised study aims to demonstrate in patients with active cancer and symptomatic or incidental PE without HESTIA criteria, that home treatment is non-inferior to hospitalisation as regards the 14-day rate of the composite primary endpoint. Primary endpoint corresponds to the rate of the composite of centrally adjudicated recurrent incidental or symptomatic VTE (i.e.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years
- Symptomatic or incidental hemodynamically stable PE objectively confirmed ≤ 24h according to the ESC guidelines
- Active cancer other than basal-cell or squamous-cell carcinoma of the skin defined at least by one of the followings:
- cancer that has been diagnosed within the past 6 months,
- cancer for which anti-cancer treatment is being given at the time of enrolment or during 6 months before randomisation, or recurrent locally advanced...
You likely can't join if
- Diagnosis of PE established for over 24h before inclusion
- Shock or hypotension defined as systolic blood pressure \ 15 minutes, if not caused by new-onset arrhythmia, hypovolaemia, or sepsis
- Hospitalisation for over 24h
- ECOG performans status 3 or 4
- Impossibility for 30-day follow-up,
- Estimated life expectancy less than 30 days
See the full eligibility criteria
- Age ≥ 18 years
- Symptomatic or incidental hemodynamically stable PE objectively confirmed ≤ 24h according to the ESC guidelines
- Active cancer other than basal-cell or squamous-cell carcinoma of the skin defined at least by one of the followings:
- cancer that has been diagnosed within the past 6 months,
- cancer for which anti-cancer treatment is being given at the time of enrolment or during 6 months before randomisation, or recurrent locally advanced or metastatic cancer
- No HESTIA criteria (i.e. no other medical condition than cancer since cancer is one of the medical condition that can check "yes" to the item).
- For woman of childbearing potential: negative beta-HCG before inclusion
- Signed informed consent
- Affiliated to French " sécurité sociale "
- Good understanding of the French language
- Diagnosis of PE established for over 24h before inclusion
- Shock or hypotension defined as systolic blood pressure \ 15 minutes, if not caused by new-onset arrhythmia, hypovolaemia, or sepsis
- Hospitalisation for over 24h
- ECOG performans status 3 or 4
- Impossibility for 30-day follow-up,
- Estimated life expectancy less than 30 days
- Patient in detention by judicial or administrative decision,
- Patient placed under a legal protection measure,
- Patient unable of giving free and informed consent
- Inclusion in another treatment study requiring hospitalisation
- Pregnant or breastfeeding women
- Patient on AME (state medical aid)
The study team makes the final eligibility decision.
Where it's taking place
- Colombes, France, France
- Dijon, France, France
- Paris, France, France
- Pierre-Bénite, France, France
- Villejuif, France, France
- Amiens, France
- Angers, France
- Brest, France
- Cergy-Pontoise, France
- Clermont-Ferrand, France
- Dijon, France
- Le Chesnay, France
- Nantes, France
- Paris, France
- Rouen, France
- Saint-Priest-en-Jarez, France
- Suresnes, France
- Toulon, France
- Toulouse, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Colombes, France, France; Dijon, France, France; Paris, France, France; Pierre-Bénite, France, France; Villejuif, France, France; Amiens, France and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.