Zie protocol, hoofdstuk 3 (Objectives)
ID
Source
Brief title
Condition
- Coagulopathies and bleeding diatheses (excl thrombocytopenic)
- Maternal complications of pregnancy
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Zie protocol, hoofdstuk 3 (Objectives)
Secondary outcome
Zie protocol, hoofdstuk 3 (Objectives)
Background summary
Zie protocol, hoofdstuk 1 & 2 (Introduction & Background and rationale)
Study objective
Zie protocol, hoofdstuk 3 (Objectives)
Study design
Zie protocol, hoofdstuk 6 (Methods)
Intervention
Zie protocol, hoofdstuk 6&7 (Methods & Specific methods)
Study burden and risks
Both the risks and the burden for the study participants are minimal. Some will
be asked to be subjected to a short (and harmless) MRDTI scan. Considering the
current literature, it is our strong hypothesis that the risk of a missed
diagnoses of venous thromboembolism by applying the study algorithm is very
low.
Albinusdreef 2
Leiden 2300RC
NL
Albinusdreef 2
Leiden 2300RC
NL
Listed location countries
Inclusion criteria
* pregnant women with suspected DVT, defined as i) new leg swelling or edema
with onset in the last month or ii) new leg pain (buttock, groin, thigh or
calf) with onset in the last month; pregnancy is defined as a positive
pregnancy test and no sign of miscarriage
* Onset of symptoms more than 24 hours but less than 10 days ago
* Aged 18 years or older
* Willing and able to give written informed consent
Exclusion criteria
* Concomitant symptoms of suspected PE (chest pain or shortness of breath or
syncope/pre-syncope or unexplained tachycardia)
* Therapeutic anticoagulant therapy more than 48 hours prior to inclusion
(thrombosis prophylaxis is allowed)
* MRI contra-indication (including but not limited to a cardiac pacemaker or
subcutaneous defibrillator; vascular clips in the cerebral vessels; metal
splinter in the eye, a hearing aid that cannot be removed; a neurostimulator
that cannot be removed; a hydrocephalus pump; claustrophobia)
* Unable to perform MRI within 48 hours
* A medical condition, associated illness or co-morbid circumstances that
precludes completion of the study procedures (MRI and 90-day follow-up
assessment), including but not limited to life-expectancy less than 3 months,
inability to lie flat or morbid obesity preventing use of MR.
* Any reperfusion therapy (e.g. thrombolysis, surgical clot removal) initiated
for the current suspected VTE diagnosis applied before subjecting the patient
to MRDTI.
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL68905.058.19 |
Other | Trial NL7498 (NTR) |